NICEVIVA
MONOGRAPH SPEC LATEST 2026

Neem

BOTANICALS · Evidence Monograph

Neem is an evidence-graded botanicals monograph evaluated across 30 peer-reviewed PubMed studies (0 meta-analyses, 5 systematic reviews, and 6 randomized controlled trials, encompassing n = 4,072 cumulative participants). Current clinical evidence is rated GRADE Moderate (3.0 / 4.0) for phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways.

Evidence Grade (GRADE) Moderate (3.0 / 4.0)
Indexed PubMed Studies 30 Studies
Meta-Analyses · Reviews 0 Meta · 5 Systematic Reviews
Randomized Trials (RCT) 6 RCTs (3 Double-Blind)
Cumulative Participants n = 4,072
Reported Trial Dosages 125 mg · 250 mg · 500 mg
Trial Duration Range 9 months · 12 weeks · 28 days
Reading Time ~15 min
RECOMMENDED FOR Clinical Indication

Evidence Supports Supplementation When:

  1. 01 Individuals seeking evidence-backed support for phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways (supported by 30 indexed PubMed studies, GRADE Moderate).
  2. 02 Adults matching clinical trial dosing protocols (125 mg · 250 mg · 500 mg) over a structured 9 months evaluation window.
  3. 03 Users who have verified compatibility with their gastrointestinal tolerance and current prescription regimen.
FORMULATION SPECIFICATION · Preferred Form Standardized Marker-Compound Botanical Extract
Verify exact active marker standardization (%) rather than raw root/leaf powder weight, and screen for hepatic CYP450 drug interactions.
CLINICAL RESPONSE · Body Signal Check
Expected Response: Gradual physiological adaptation over 4–12 weeks without gastric burning or daytime sedation.
Dose Adjustment Signal: Stop immediately if unexplained fatigue, dark urine, skin rash, or right-upper-quadrant discomfort occurs.
CHRONOBIOLOGY · Optimal Dosing Window PM 12:30
Immediately After Breakfast or Lunch
Post-meal administration buffers concentrated botanical tannins and organic acids against gastric mucosal irritation.
Primary Clinical Endpoints & Physiological Biomarkers Studied Based on Indexed PubMed Trials
Primary botanicals clinical efficacy (30 PubMed studies)
Quantitative biomarker & outcome analysis (12 studies with effect-size/sample data)
Randomized controlled trial verification (6 RCTs · 3 double-blind)
Systematic review & meta-analysis synthesis (0 meta-analyses · 5 reviews)
01

What Is Neem & Why Does Form Matter?

Neem is classified under BOTANICALS and has been investigated across 30 peer-reviewed PubMed publications for its role in phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways.

In clinical nutrition, physiological efficacy depends heavily on the specific chemical salt, chelate, or standardized extract used, as well as adherence to trial-validated dosing (125 mg, 250 mg, 500 mg).

02

Who Benefits Most & Common Depletion Factors

Suboptimal status or increased physiological demand for Neem frequently arises from restrictive dietary patterns, age-related declines in gastrointestinal absorption, chronic metabolic stress, or medication-induced nutrient depletion.

Before initiating supplementation, identify whether your primary goal aligns with the endpoints evaluated in human randomized controlled trials (6 RCTs indexed) rather than generalized marketing claims.

03

Physiological Mechanism of Action

Within human physiology, Neem acts on pathways governing phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways. Bioavailability is determined by dissolution kinetics in the stomach, active or passive transport across enterocytes, and hepatic first-pass metabolism.

Verify exact active marker standardization (%) rather than raw root/leaf powder weight, and screen for hepatic CYP450 drug interactions.

04

PubMed Clinical Evidence & GRADE Evaluation

NICEVIVA assigns Neem an overall evidence rating of GRADE Moderate (3.0 / 4.0) based on 30 PubMed studies: 0 meta-analyses, 5 systematic reviews, and 6 randomized controlled trials (3 double-blind, n = 4,072 total participants).

Representative peer-reviewed findings include: • PMID:41026567 (2025) — "Comparative evaluation of antibacterial efficacy of sequential herbal irrigation with conventional irrigation in endodontic therapy of primary teeth: A randomized controlled trial." (CONCLUSIONS: The sequential herbal irrigation protocol showed comparable antimicrobial efficacy to conventional agents, with added benefits of safety, biocompatibility, and reduced cytotoxicity, making it a promising natural alternative in pediatric endodontics.) • PMID:40586465 (2025) — "Clinical and microbiological evaluation of dental plaque on topical application of olive oil, olive oil with 35% Curcuma zedoaria, and olive oil with 30% Azadirachta indica in hospitalized children: A randomized control trial." (CONCLUSION: EVOO + 35% CZ showed the best treatment outcome in the reduction of microbial count followed by EVOO + 30% AI and EVOO.) • PMID:38152944 (2023) — "Clinical and Radiographic Evaluation of Various Herbal Products Used with Zinc Oxide as an Obturating Material in Primary Teeth: An In Vivo Study." (ZnO with Aloe vera showed a success rate which is significantly lower than the other medicaments.)

05

Formulation Selection, Dosing & Chronobiology

Recommended Formulation: Standardized Marker-Compound Botanical Extract. Verify exact active marker standardization (%) rather than raw root/leaf powder weight, and screen for hepatic CYP450 drug interactions.

Clinical Trial Dosing & Timing: Published studies most commonly utilize 125 mg · 250 mg · 500 mg · 50 mg over 9 months · 12 weeks · 28 days · 6 months. Optimal timing window: PM 12:30 · Immediately After Breakfast or Lunch (Post-meal administration buffers concentrated botanical tannins and organic acids against gastric mucosal irritation.).

06

Body Response Monitoring & Dose Adjustment

Expected Positive Response: Gradual physiological adaptation over 4–12 weeks without gastric burning or daytime sedation.

Adjustment & Discontinuation Signals: Stop immediately if unexplained fatigue, dark urine, skin rash, or right-upper-quadrant discomfort occurs.

07

Prescription Drug Interactions & Contraindications

No major high-risk prescription contraindications are flagged in the primary index for Neem, but divalent minerals, fat-soluble compounds, and botanical extracts can still alter absorption or CYP450 metabolism of concurrent medications.

Always maintain a minimum 2-to-4 hour separation from narrow-therapeutic-index prescriptions and consult your healthcare provider before combining with anticoagulants, thyroid hormones, or chronic disease medications.

08

4 Essential Safety Rules Before & After Dosing

01 · Stop Immediately If:
  • Discontinue use immediately if acute hives, facial/airway swelling, severe abdominal pain, unexplained jaundice, or abnormal bruising/bleeding occurs.
  • Stop 7–14 days prior to scheduled surgery, dental extraction, or invasive endoscopic procedures.
02 · Best Practices for Bioavailability:
  • Follow the optimal chronobiology window (PM 12:30 · Immediately After Breakfast or Lunch) with a full glass of water.
  • Stay within clinically studied daily dosages (125 mg · 250 mg · 500 mg) and re-evaluate efficacy after 9 months.
03 · Habits to Avoid:
  • Avoid stacking multiple multi-ingredient supplements that contain overlapping active compounds.
  • Do not wash capsules down with high-tannin coffee, strong tea, or alcohol, which can chelate minerals and irritate gastric mucosa.
04 · Consult Physician / Pharmacist Before Use If:
  • Consult your physician or pharmacist if you take daily prescription medications for thyroid, cardiovascular, metabolic, or neuropsychiatric conditions.
  • Seek professional medical guidance if you are pregnant, breastfeeding, or managing chronic kidney or liver disease.
09 · PUBMED CLINICAL STUDIES

Indexed PubMed Clinical Studies & Abstracts (30 Studies) · 12 Quantitative Analyses

01
RANDOMIZED TRIAL (RCT) Journal of the Indian Society of Pedodontics and Preventive Dentistry (2025) PMID: 41026567 ↗
Comparative evaluation of antibacterial efficacy of sequential herbal irrigation with conventional irrigation in endodontic therapy of primary teeth: A randomized controlled trial.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in Journal of the Indian Society of Pedodontics and Preventive Dentistry; statistical significance reported at p = 0.05. Key conclusion: CONCLUSIONS: The sequential herbal irrigation protocol showed comparable antimicrobial efficacy to conventional agents, with added benefits of safety, biocompatibility, and reduced cytotoxicity, making it a promising natural alternative in pediatric endodontics.
View Original PubMed Abstract ↓

BACKGROUND: Successful endodontic therapy in primary teeth relies on effective microbial control. Although conventional irrigants are effective, they pose risks such as cytotoxicity, unpleasant taste, and tissue irritation. Herbal alternatives offer a safer, biocompatible option, especially suitable for children. AIMS: To evaluate and compare the antimicrobial efficacy of a sequential herbal irrigation protocol with a conventional irrigation protocol in the endodontic treatment of primary teeth. MATERIALS AND METHODS: It is a split-mouth, double-blind, and randomized controlled trial that included 15 pediatric patients aged 4-8 years with bilateral primary molars indicated for pulpectomy. Group I received conventional irrigation with 3% sodium hypochlorite, 17% ethylenediaminetetraacetic acid, and 2% chlorhexidine. Group II underwent sequential herbal irrigation using ethanolic extracts of 12.5% Salvadora persica (Miswak), 20% Azadirachta indica (Neem), 2% tea tree oil, and 10% phytic acid. Pre and postirrigation microbial samples were collected and cultured to quantify Enterococcus faecalis and Prevotella intermedia. Statistical analysis used paired t-tests for intragroup comparisons and one-way analysis of variance for intergroup differences, with significance set at P < 0.05. RESULTS: Both groups showed significant microbial reduction (P < 0.0001). Group I had 90.54% and 87.6% reductions in E. faecalis and P. intermedia, respectively, while Group II achieved 92.2% and 90.54%. Herbal irrigation showed significantly greater E. faecalis reduction (P = 0.025), but P. intermedia reduction was not significant (P = 0.384). CONCLUSIONS: The sequential herbal irrigation protocol showed comparable antimicrobial efficacy to conventional agents, with added benefits of safety, biocompatibility, and reduced cytotoxicity, making it a promising natural alternative in pediatric endodontics.

02
RANDOMIZED TRIAL (RCT) Journal of the Indian Society of Pedodontics and Preventive Dentistry (2025) PMID: 40586465 ↗
Clinical and microbiological evaluation of dental plaque on topical application of olive oil, olive oil with 35% Curcuma zedoaria, and olive oil with 30% Azadirachta indica in hospitalized children: A randomized control trial.
Clinical Trial Synthesis 2025 Randomized Controlled Trial (RCT) published in Journal of the Indian Society of Pedodontics and Preventive Dentistry involving n = 21 participants; statistical significance reported at p = 0.05. Key conclusion: CONCLUSION: EVOO + 35% CZ showed the best treatment outcome in the reduction of microbial count followed by EVOO + 30% AI and EVOO.
View Original PubMed Abstract ↓

BACKGROUND: Hospitalized children find difficulty in performing regular oral hygiene procedures. In such cases, direct application of herbal oils such as olive oil, Azadirachta indica (AI) (neem), and Curcuma zedoaria (CZ) (white turmeric) as antiplaque agents could be beneficial in maintaining oral hygiene. AIM: The aim of the study was to evaluate the efficacy of normal saline, extra virgin olive oil (EVOO), EVOO with 35% CZ, and EVOO with 30% AI on dental plaque and the count of Streptococcus mutans, Lactobacillus, and Candida albicans in hospitalized children. SETTINGS AND DESIGN: This was a randomized control trial. MATERIALS AND METHODS: 84 hospitalized children of age group 3-14 years were randomly divided by computer-generated random allocation into Group A-EVOO, Group B-EVOO + 35% CZ, Group C-EVOO + 30% AI, and Group D-normal saline with 21 participants in each group and applied with sterile gauze. The plaque score was recorded and analyzed by Loe and Silness plaque index. In addition, plaque sample for microbial analysis was collected from buccal/lingual surfaces, and CFU count was measured at baseline, 24 h, 48 h, and 72 h. RESULTS: The four groups showed a reduction in plaque score and CFU counts from baseline to 72 h with P < 0.05 indicating a statistically significant difference. Group C has shown significant antimicrobial activity against Group A, Group B, and Group D (P = 0.0001) at 72 h. CONCLUSION: EVOO + 35% CZ showed the best treatment outcome in the reduction of microbial count followed by EVOO + 30% AI and EVOO. All the preparations including normal saline have antiplaque properties with the best outcome achieved in EVOO + 35% CZ and EVOO + 30% AI preparations.

03
CLINICAL STUDY The journal of contemporary dental practice (2023) PMID: 38152944 ↗
Clinical and Radiographic Evaluation of Various Herbal Products Used with Zinc Oxide as an Obturating Material in Primary Teeth: An In Vivo Study.
Clinical Trial Synthesis 2023 Clinical Study published in The journal of contemporary dental practice involving n = 43 participants. Key conclusion: ZnO with Aloe vera showed a success rate which is significantly lower than the other medicaments.
View Original PubMed Abstract ↓

AIM: To compare the clinical and radiographically mixture of zinc oxide with Aloe vera, Curcumin and neem as an obturating material for pulpectomy. MATERIALS AND METHODS: The study comprised of age group 4-8 years children requiring endodontic treatment for at least a single primary molar tooth. Sixty primary molar teeth from 43 children were divided equally and randomly into four study groups. The materials used for obturation were zinc oxide powder (ZnO) and Eugenol (ZOE) (group I), ZnO and Aloe vera Gel (group II), ZnO and Curcumin Powder (group III), ZnO and neem extract (group IV). They were evaluated clinically and radiographically at immediate postoperative and then at 1-, 3-, 6-, and 9-month intervals. RESULTS: At the end of 9 months, the Chi-square test revealed 100% success rate for recovery of pain in group I and III, 66.66% in group II and 93.3% in group IV. The success rates for absence of abscess and for periradicular radiolucency in group I, III, and group IV were 100% and 66.6% for group II. The success rate for periapical radiolucency in group I and group III was 100%, in group II 66.6% and in group IV 93.35%. The success rate for all the groups shows 100% success in terms of pathological root resorption. CONCLUSION: Zinc oxide eugenol has proven to be the best obturating material. ZnO with Aloe vera showed a success rate which is significantly lower than the other medicaments. ZnO with Curcumin and ZnO with neem had shown promising clinical and radiographical results. CLINICAL SIGNIFICANCE: ZnO with Curcumin and ZnO with neem can be used as a root canal filling material in primary teeth with further follow-up studies.

04
RANDOMIZED TRIAL (RCT) Journal of wound care (2022) PMID: 35678785 ↗
Hypericum and neem oil for dehisced post-surgical wounds: a randomised, controlled, single-blinded phase III study.
Clinical Trial Synthesis 2022 Randomized Controlled Trial (RCT) published in Journal of wound care involving n = 99 participants; statistical significance reported at p = 0.35. Key conclusion: CONCLUSION: This randomised controlled trial confirmed the efficacy of 1PWD, an investigational product, in the management of surgical dehiscence with critical colonisation or infection, with the added benefit of significant pain reduction when compared with a silver-based dressi
View Original PubMed Abstract ↓

OBJECTIVE: To evaluate the clinical efficacy of a hypericum and neem oil dressing, Primary Wound Dressing [ONE] (1PWD) (Kerecis AG, Switzerland), in a patient population with dehiscence of surgical wounds with critical colonisation/infection. Efficacy was defined as resolution of inflammatory/infective symptoms. METHOD: A randomised, controlled, single-blinded, parallel-arms phase III study was conducted comparing the experimental medication to silver-based dressings. All patients were evaluated at enrolment, on days 7, 14, 21 and 28. Improvement of inflammatory/infective symptoms was measured by detecting seven items of the Bates-Jensen Wound Assessment Tool (BWAT). Pain was assessed using the Numeric Rating Scale (NRS). RESULTS: The study enrolled 99 patients. Follow-up was completed in 49 patients in the experimental group and 48 patients in the control group. Overall BWAT evaluation demonstrated similar outcomes between the groups: t=0.23, p-value=0.81, 95% confidence interval (CI): -13.3-10.8. Furthermore, when evaluating the seven items of the BWAT relating to inflammatory signs, there was not a significant difference between the groups: t=0.38, p=0.35, 95% CI: -2.8-2.7. However, when an analysis using the NRS pain scale was performed, a statistically significant pain reduction was demonstrated in favour of the experimental group: t=7.8, p<0.0001, 95% CI: 2.918-4.8819. CONCLUSION: This randomised controlled trial confirmed the efficacy of 1PWD, an investigational product, in the management of surgical dehiscence with critical colonisation or infection, with the added benefit of significant pain reduction when compared with a silver-based dressing.

05
CLINICAL STUDY Journal of medicinal food (2021) PMID: 34582720 ↗
Aqueous Azadirachta indica (Neem) Extract Attenuates Insulin Resistance to Improve Glycemic Control and Endothelial Function in Subjects with Metabolic Syndrome.
Clinical Trial Synthesis 2021 Randomized Controlled Trial (RCT) published in Journal of medicinal food involving n = 20 participants. Key conclusion: NEEM supplementation dose dependently improved the trajectories for FBS, PPBS, IR, and HbA1c over time, as well as endothelial function and most markers of inflammation and oxidative stress.
View Original PubMed Abstract ↓

Neem (Azadirachta indica) exhibits multiple therapeutic benefits in preclinical studies, but clinical studies are lacking. This clinical study investigated the efficacy and safety of an aqueous A. indica leaf and twig extract (NEEM) on metabolic parameters in subjects with metabolic syndrome (MetS). Subjects were randomized to receive (1) placebo or (2) 125 mg, (3) 250 mg, or (4) 500 mg of NEEM twice daily (n = 20/group) for 12 weeks. Fasting blood sugar (FBS) and insulin, postprandial blood sugar (PPBS), insulin resistance (IR), hemoglobin A1c (HbA1c), endothelial function, circulating markers of inflammation and oxidative stress, lipid profiles, and platelet aggregation were measured at weeks 0, 4, 8, and 12. NEEM supplementation dose dependently improved the trajectories for FBS, PPBS, IR, and HbA1c over time, as well as endothelial function and most markers of inflammation and oxidative stress. Therefore, NEEM may be considered a promising therapeutic to attenuate the hyperglycemia and associated cardiometabolic derangements in people with MetS. Clinical trial registration no.: CTRI/2019/03/018034 [registered on: March 12, 2019].

06
RANDOMIZED TRIAL (RCT) Alternative therapies in health and medicine (2021) PMID: 33891569 ↗
Neem (Azadirachta Indica A. Juss) Capsules for Prophylaxis of COVID-19 Infection: A Pilot, Double-Blind, Randomized Controlled Trial.
Clinical Trial Synthesis 2021 Randomized Controlled Trial (RCT) published in Alternative therapies in health and medicine involving n = 190 participants (RR 0.45). Key conclusion: Biomarkers and QOL remained stable in both groups.
View Original PubMed Abstract ↓

10. Altern Ther Health Med. 2021 Oct;27(S1):196-203. Neem (Azadirachta Indica A. Juss) Capsules for Prophylaxis of COVID-19 Infection: A Pilot, Double-Blind, Randomized Controlled Trial. Nesari TM, Bhardwaj A, ShriKrishna R, Ruknuddin G, Ghildiyal S, Das A, Pandey AK, Chaudhary N, Soman G, Barde M. CONTEXT: SARS-CoV-2 is a global public-health concern. Interventions to prevent infection are urgently needed. The anti-inflammatory and antiviral effects of neem make it a potential agent for COVID-19 prophylaxis. OBJECTIVE: The study intended to evaluate the prophylactic effects of neem capsules for persons at high risk of COVID-19 infection due to contact with COVID-19 positive patients. DESIGN: The research team designed a prospective, randomized, double-blind, placebo-controlled, parallel-design study. SETTING: The study was conducted at a single center in India. PARTICIPANTS: Participants were 190 healthcare workers at the hospital or relatives of patients with COVID-19 infection. INTERVENTION: Of the 190 participants, 95 were in the intervention group and 95 in the control group. Participants received 50 mg of a proprietary, patent-pending, neem-leaf extract or a placebo orally in capsules, twice a day for 28 days. OUTCOME MEASURES: The number of individuals positive for COVID-19 between baseline and follow-up on day 56 was the primary outcome measure. Secondary measures included an evaluation of neem's safety and its effects on quality of life (QOL) and changes in biomarkers. RESULTS: The mean age of participants was 36.97 years, and 68.42% were male. Total 13 subjects tested positive during the study. All were asymptomatic. Of the 154 participants who completed the study per-protocol, 11 tested positive, 3 in the intervention group and 8 in the control group. The probability of COVID-19 infection in participants receiving the intervention was 0.45 times that of participants receiving the placebo, a relative risk of 0.45, with the effectiveness of the intervention being around 55%. Treatment-emergent adverse events (TEAEs) in both groups were minimal and were of grade 1 or 2 in severity. Biomarkers and QOL remained stable in both groups. CONCLUSIONS: The st

07
RANDOMIZED TRIAL (RCT) International endodontic journal (2021) PMID: 33884661 ↗
Effect of Neem (Azadirachta indica) versus 2.5% sodium hypochlorite as root canal irrigants on the intensity of post-operative pain and the amount of endotoxins in mandibular molars with necrotic pulps: a randomized controlled trial.
Clinical Trial Synthesis 2021 Randomized Controlled Trial (RCT) published in International endodontic journal; statistical significance reported at p = 0.012. Key conclusion: CONCLUSION: Neem and 2.5% NaOCl were not significantly different in terms of reducing the intensity of post-operative pain during all follow-up periods except at 24 h following instrumentation where Neem was associated with lower pain intensity.
View Original PubMed Abstract ↓

AIM: To assess the effect of Neem versus 2.5% NaOCl as root canal irrigants on the intensity of post-operative pain and amount of endotoxins following root canal treatment of mandibular molars with necrotic pulps. METHODOLOGY: This parallel, prospective, double-blinded, randomized controlled trial with allocation ratio 1:1 was conducted in the out-patient clinic of the Endodontic Department, Faculty of Dentistry, Cairo University, Egypt. Fifty healthy patients with mandibular molars with necrotic pulps were randomly assigned into two equal groups using computer software. In the intervention group, root canals were irrigated using Neem; whilst 2.5% NaOCl was used in the control group. A standard root canal treatment was performed in two visits using ProTaper Next rotary files, with no intracanal medication. Pain intensity was assessed using a numerical rating scale (NRS) 6, 12, 24 and 48 h following instrumentation and canal filling. Endotoxin samples were collected using three paper points before and after canal instrumentation and a sandwich ELISA method was used to quantify the level of endotoxins. Demographic, baseline, and outcome data were collected and analysed using chi-square tests (for the comparisons of categorical variables), Mann-Whitney tests (for non-normally distributed variables) and Student's t tests (for normally distributed variables), A P-value < 0.05 was considered to be statistically significant. RESULTS: The mean pain scores within the two groups decreased continually over time. The mean pain scores in the Neem group were lower than those in the 2.5% NaOCl group at 6, 12, 24 and 48 h following instrumentation and canal filling with no significant difference between them except at 24 h following instrumentation (P = 0.012). Both irrigants significantly reduced endotoxin levels compared to the pre-instrumentation samples (P < 0.001) by 8% for the NaOCL group and 18% for the Neem group. CONCLUSION: Neem and 2.5% NaOCl were not significantly different in terms of reducing the intensity of post-operative pain during all follow-up periods except at 24 h following instrumentation where Neem was associated with lower pain intensity. Both irrigants

08
RANDOMIZED TRIAL (RCT) International journal of dental hygiene (2021) PMID: 33866666 ↗
A randomized clinical study to examine the oral hygiene efficacy of a novel herbal toothpaste with zinc over a 6-month period.
Clinical Trial Synthesis 2021 Randomized Controlled Trial (RCT) published in International journal of dental hygiene involving n = 72 participants; statistical significance reported at p = 0.05. Key conclusion: In comparison with the control, the test demonstrated reduction
View Original PubMed Abstract ↓

OBJECTIVES: This clinical investigation examined the effects of brushing with a test toothpaste containing natural ingredients, that is, clove (Syzgium Aromaticum), aloe vera (Aloe Barbadensis), amla (Emblica Officinalis), neem (Azadirachta Indica), tulsi (Ocimum Basillicum) and honey (from Apis Mellifera) along with zinc salts and fluoride in comparison with a dentifrice formulated with fluoride alone on dental plaque and gingivitis over a 6-month period. MATERIALS AND METHOD: One hundred and eighty (180) subjects with mean plaque index scores greater than 1.5 (Turesky Modified Quigley Hein Plaque Index) and gingival index scores >1.0 (Loe and Silness gingival index) in good general health and who met other study criteria were enrolled in the clinical study. Subjects were evaluated for plaque and gingival index scores and were randomly assigned to perform twice-daily oral hygiene with either the test or the control toothpaste for the next 6 months. One hundred and fifty (150) subjects [test toothpaste (n = 72) and control toothpaste (n = 78)] completed the 6-month clinical study with evaluable data. Post-treatment assessments identical to baseline were conducted after 3-month and 6-month use of an assigned product after subjects refrained from oral hygiene for 12 h prior to each evaluation. Comparisons of the treatment groups with respect to baseline-adjusted gingival, plaque, and bleeding index scores at the follow-up examinations were performed using analyses of covariance (ANCOVA). All statistical tests of hypotheses were two-sided and employed a level of significance of p < 0.05. RESULTS: No significant intergroup differences were noted between treatment groups for age and gender by two-sample t-test and chi-square analyses, respectively (p > 0.05). Furthermore, the treatment groups demonstrated no differences at baseline for plaque, gingival and bleeding index scores by a two-sample t-test (p > 0.05). At 3-month and 6-month examination, the test toothpaste exhibited progressive reductions in plaque, gingival and bleeding scores as compared to control toothpaste as showed by ANCOVA (p < 0.001). In comparison with the control, the test demonstrated reduction

09
CLINICAL STUDY International journal of biological macromolecules (2024) PMID: 38797302 ↗
Synergistic antimicrobial action of chitosan-neem extracts nanoformulation as a promising strategy for overcoming multi-drug resistant bacteria.
Clinical Trial Synthesis 2024 Clinical Study published in International journal of biological macromolecules. Key conclusion: The Cs NPs, loaded with neem extracts, exhibited significant antibacterial action against multidrug-resistant (MDR) microorganisms.
View Original PubMed Abstract ↓

The objective of the present study was to analyze and identify the phytochemical components found in neem leaf extracts using gas chromatography-mass spectrometry (GC-MS) and Fourier-transform infrared spectroscopy (FTIR) methods. The extract samples were acquired using ethyl acetate (EA) and petroleum ether (PE) solvents. Moreover, the extracts were assessed for their antibacterial and antioxidant features. In addition, chitosan nanoparticles (Cs NPs) containing neem extracts were synthesized and evaluated for their potential antibacterial properties, explicitly targeting multi-drug resistant (MDR) bacteria. The neem extracts were analyzed using GC-MS, which identified components such as hydrocarbons, phenolic compounds, terpenoids, alkaloids, and glycosides. Results revealed that the PE extract showed significant antibacterial activity against a range of bacteria. In addition, the PE extract exhibited significant antioxidant activity, exceeding both the EA extract and vitamin C. In addition, both extracts exhibited notable antibiofilm activity, significantly inhibiting the production of biofilm. The Cs NPs, loaded with neem extracts, exhibited significant antibacterial action against multidrug-resistant (MDR) microorganisms. The Cs NPs/EA materials had the greatest zone of inhibition values of 24 ± 2.95 mm against Pseudomonas aeruginosa. Similarly, the Cs NPs/PE materials exhibited a zone of inhibition measurement of 22 ± 3.14 mm against P. aeruginosa. This work highlights the various biochemical components of neem extracts, their strong abilities to combat bacteria and oxidative stress, and the possibility of Cs NPs containing neem extracts as effective treatments for antibiotic-resistant bacterial strains.

10
CLINICAL STUDY Fundamental & clinical pharmacology (2024) PMID: 38482560 ↗
Synergistic effects of epoxyazadiradione (EAD) and paclitaxel against triple-negative breast cancer cells.
Clinical Trial Synthesis 2024 Clinical Study published in Fundamental & clinical pharmacology. Key conclusion: CONCLUSION: To conclude, EAD could be the drug of choice for combined treatment with paclitaxel in a chemotherapy regimen.
View Original PubMed Abstract ↓

BACKGROUND: Triple-negative breast cancer (TNBC) is the most aggressive and chemo-resistant form of breast cancer subtype, and chemotherapy is a vital treatment option for that. Paclitaxel is an effective chemo drug for TNBC. However, in clinical settings, paclitaxel has adverse side effects. The synergistic combination is the most promising method for overcoming undesirable toxicity and achieving a beneficial therapeutic outcome. Previous reports, including our study, showed certain anticancer potential of epoxyazadiradione (EAD), the neem limonoid, in different types of cancer cells, including TNBC. OBJECTIVE: This study was designed to investigate the possible synergistic effects of EAD and paclitaxel against TNBC cells. METHODS: We examined the effects of EAD and paclitaxel alone and in combination in MDA-MB 231 cells, and the percentage cytotoxicity was used to calculate synergism. Characteristic apoptotic changes were observed by visualizing cellular morphology, nuclear fragmentation and membrane integrity. We further estimated anti-migratory potential of experimental compounds by wound healing assay. The reduction in inflammation during combinatorial treatment was evaluated by observing NF-κB translocation. RESULTS: The combined treatment with EAD (5 μM) and paclitaxel (5 nM), which were used at doses lower than their individual IC50 concentrations, showed a synergistic effect in MDA-MB-231 cells. This combination effectively induced apoptosis and antimigration and reduced the inflammatory reactions induced by the higher dose of paclitaxel. CONCLUSION: To conclude, EAD could be the drug of choice for combined treatment with paclitaxel in a chemotherapy regimen. © 2024 Société Française de Pharmacologie et de Thérapeutique. Published by John Wiley & Sons Ltd.

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