NICEVIVA
MONOGRAPH SPEC LATEST 2026

Holy Basil (Tulsi)

BOTANICALS · Evidence Monograph

Holy Basil (Tulsi) is an evidence-graded botanicals monograph evaluated across 22 peer-reviewed PubMed studies (0 meta-analyses, 0 systematic reviews, and 8 randomized controlled trials, encompassing n = 292 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 22 Studies
Meta-Analyses · Reviews 0 Meta · 0 Systematic Reviews
Randomized Trials (RCT) 8 RCTs (4 Double-Blind)
Cumulative Participants n = 292
Reported Trial Dosages 21.68 g · 500 μg · 30 μg
Trial Duration Range 14 days · 12 weeks · 90 days
Reading Time ~11 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 22 indexed PubMed studies, GRADE Moderate).
  2. 02 Adults matching clinical trial dosing protocols (21.68 g · 500 μg · 30 μg) over a structured 14 days 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 (22 PubMed studies)
Quantitative biomarker & outcome analysis (12 studies with effect-size/sample data)
Randomized controlled trial verification (8 RCTs · 4 double-blind)
Systematic review & meta-analysis synthesis (0 meta-analyses · 0 reviews)
01

What Is Holy Basil (Tulsi) & Why Does Form Matter?

Holy Basil (Tulsi) is classified under BOTANICALS and has been investigated across 22 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 (21.68 g, 500 μg, 30 μg).

02

Who Benefits Most & Common Depletion Factors

Suboptimal status or increased physiological demand for Holy Basil (Tulsi) 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 (8 RCTs indexed) rather than generalized marketing claims.

03

Physiological Mechanism of Action

Within human physiology, Holy Basil (Tulsi) 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 Holy Basil (Tulsi) an overall evidence rating of GRADE Moderate (3.0 / 4.0) based on 22 PubMed studies: 0 meta-analyses, 0 systematic reviews, and 8 randomized controlled trials (4 double-blind, n = 292 total participants).

Representative peer-reviewed findings include: • PMID:31739106 (2020) — "An interaction study of Ocimum sanctum L. and levetiracetam in pentylenetetrazole kindling model of epilepsy." (CONCLUSIONS: Ocimum per se and combination with levetiracetam treatment exerted better seizure control, memory retention, oxidative stress reduction, and neuronal structure preservation than kindling control group.) • PMID:22305788 (2012) — "Enhancing chloramphenicol and trimethoprim in vitro activity by Ocimum sanctum Linn. (Lamiaceae) leaf extract against Salmonella enterica serovar Typhi." (CONCLUSIONS: The data suggest that TLE, in combination with C and Tm, had synergistic activity for S.) • PMID:21803027 (2011) — "Anti-cancer effects of novel flavonoid vicenin-2 as a single agent and in synergistic combination with docetaxel in prostate cancer." (In conclusion, our investigations collectively provide strong evidence that VCN-2 is effective against CaP progression along with indicating that VCN-2 and DTL co-administration is more effective than either of the single agents in androgen-independent prostate cancer.)

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 21.68 g · 500 μg · 30 μg · 5 μg over 14 days · 12 weeks · 90 days · 21 days. 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 Holy Basil (Tulsi), 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 (21.68 g · 500 μg · 30 μg) and re-evaluate efficacy after 14 days.
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 (22 Studies) · 12 Quantitative Analyses

01
CLINICAL STUDY Journal of ethnopharmacology (2020) PMID: 31739106 ↗
An interaction study of Ocimum sanctum L. and levetiracetam in pentylenetetrazole kindling model of epilepsy.
Clinical Trial Synthesis 2020 Clinical Study published in Journal of ethnopharmacology; statistical significance reported at p = 0.031. Key conclusion: CONCLUSIONS: Ocimum per se and combination with levetiracetam treatment exerted better seizure control, memory retention, oxidative stress reduction, and neuronal structure preservation than kindling control group.
View Original PubMed Abstract ↓

ETHNOPHARMACOLOGICAL RELEVANCE: Ocimum sanctum L. commonly known as tulsi (synonym of Ocimum tenuiflorum L.) is widely used in Ayurveda medicine and is having multitude neuromodulatory effect including the anticonvulsant effect in acute seizure models as per previous studies. In India, it is used for the treatment of epilepsy as traditional medicine. However, its role in chronic seizure model and interaction with newer antiepileptic drugs has not been investigated, which will enhance its translational value. AIM OF THE STUDY: Current study investigated the effect of Ocimum on chronic seizure model and its interaction with levetiracetam (LEV), a newer antiepileptic drug. MATERIALS AND METHODS: The adjuvant role of Ocimum sanctum hydroalcoholic extracts (OSHE) 1000 mg/kg along with LEV 300 mg/kg was studied in adult male Wistar rats with mean weight of 227.84 ± 21.68 g using pentylenetetrazole (30 mg/kg, i.p.) kindling (K) (with maximum 24 injections on alternate days and challenge on 7th-day). Along with seizure score, neurobehavioral, brain tissue oxidative stress and histopathology status were assessed. Pharmacokinetic interaction was assessed between LEV and OSHE after 14 days of drug treatment. RESULTS: K-LEV + OSHE had least seizure score during kindling and on the pentylenetetrazole-challenge test (p=0.031) than other kindling groups. Seizure protection was more in K-LEV + OSHE (85.72%) than others (K-LEV-42.86%, K-OSHE-42.86%, and K-Control-28.58%). Ocimum treated groups had better memory retention potential as evident from Morris water maze (MWM), passive avoidance test but not in an elevated plus maze test. Oxidative-stress was lower in Ocimum treated groups than K-Control group. As per histopathology, K-LEV + OSHE group had the least neuronal degeneration among kindling groups. There was no significant pharmacokinetic interaction between LEV and OSHE, except increased Tmax in LEV + OSHE group than LEV alone (p=0.009). CONCLUSIONS: Ocimum per se and combination with levetiracetam treatment exerted better seizure control, memory retention, oxidative stress reduction, and neuronal structure preservation than kindling control group. There was a very minimal

02
CLINICAL STUDY Asian Pacific journal of tropical medicine (2012) PMID: 22305788 ↗
Enhancing chloramphenicol and trimethoprim in vitro activity by Ocimum sanctum Linn. (Lamiaceae) leaf extract against Salmonella enterica serovar Typhi.
Clinical Trial Synthesis 2012 Clinical Study published in Asian Pacific journal of tropical medicine involving n = 23 participants. Key conclusion: CONCLUSIONS: The data suggest that TLE, in combination with C and Tm, had synergistic activity for S.
View Original PubMed Abstract ↓

OBJECTIVE: To evaluate the antibacterial activity of Ocimum sanctum (O. sanctum) leaf extract, alone, and in combination with chloramphenicol (C) and trimethoprim (Tm) against Salmonella enterica serovar Typhi (S. typhi). METHODS: The antibacterial activity of ethanolic extract of tulsi, O. sanctum, leaf (TLE; 500 μg) for 23 S. typhi isolates was determined following agar diffusion. The C (30 μg) and Tm (5 μg) activity alone and in combination with TLE (250 μg) was determined by disk diffusion. The zone diameter of inhibition (ZDI) for the agents was recorded, and growth inhibitory indices (GIIs) were calculated. RESULTS: The S. typhi isolates (n=23), which were resistant to both C (ZDI 6 mm) and Tm (ZDI 6 mm), had TLE (500 μg) ZDIs 16-24 mm. The ZDIs of C and Tm were increased up to 15-21 mm and 17-23 mm, respectively, when TLE (250 μg) was added to the C and Tm discs. The GIIs ranged 0.789-1.235 and 0.894-1.352, due to combined activity against S. typhi isolates, of C and TLE and Tm and TLE, respectively. CONCLUSIONS: The data suggest that TLE, in combination with C and Tm, had synergistic activity for S. typhi isolates, and hence O. sanctum is potential in combating S. typhi drug resistance, as well promising in the development of non-antibiotic drug for S. typhi infection.

03
CLINICAL STUDY Biochemical pharmacology (2011) PMID: 21803027 ↗
Anti-cancer effects of novel flavonoid vicenin-2 as a single agent and in synergistic combination with docetaxel in prostate cancer.
Clinical Trial Synthesis 2011 Clinical Study published in Biochemical pharmacology. Key conclusion: In conclusion, our investigations collectively provide strong evidence that VCN-2 is effective against CaP progression along with indicating that VCN-2 and DTL co-administration is more effective than either of the single agents in androgen-independent prostate cancer.
View Original PubMed Abstract ↓

The present study was conducted to determine the efficacy of novel flavonoid vicenin-2 (VCN-2), an active constituent of the medicinal herb Ocimum Sanctum Linn or Tulsi, as a single agent and in combination with docetaxel (DTL) in carcinoma of prostate (CaP). VCN-2 effectively induced anti-proliferative, anti-angiogenic and pro-apoptotic effect in CaP cells (PC-3, DU-145 and LNCaP) irrespective of their androgen responsiveness or p53 status. VCN-2 inhibited EGFR/Akt/mTOR/p70S6K pathway along with decreasing c-Myc, cyclin D1, cyclin B1, CDK4, PCNA and hTERT in vitro. VCN-2 reached a level of 2.6±0.3μmol/l in serum after oral administration in mice which reflected that VCN-2 is orally absorbed. The i.v. administration of docetaxel (DTL), current drug of choice in androgen-independent CaP, is associated with dose-limiting toxicities like febrile neutropenia which has lead to characterization of alternate routes of administration and potential combinatorial regimens. In this regard, VCN-2 in combination with DTL synergistically inhibited the growth of prostate tumors in vivo with a greater decrease in the levels of AR, pIGF1R, pAkt, PCNA, cyclin D1, Ki67, CD31, and increase in E-cadherin. VCN-2 has been investigated for radioprotection and anti-inflammatory properties. This is the first study on the anti-cancer effects of VCN-2. In conclusion, our investigations collectively provide strong evidence that VCN-2 is effective against CaP progression along with indicating that VCN-2 and DTL co-administration is more effective than either of the single agents in androgen-independent prostate cancer.

04
CLINICAL STUDY Journal of ethnopharmacology (2003) PMID: 12963158 ↗
Antinociceptive action of Ocimum sanctum (Tulsi) in mice: possible mechanisms involved.
Clinical Trial Synthesis 2003 Clinical Study published in Journal of ethnopharmacology. Key conclusion: OS (50, 100 mg/kg, i.p.) also increased the tail withdrawal latency in mice.
View Original PubMed Abstract ↓

The alcoholic leaf extract of Ocimum sanctum (OS, Tulsi) was tested for analgesic activity in mice. In the glacial acetic acid (GAA)-induced writhing test, OS (50, 100 mg/kg, i.p.; and 50, 100, 200 mg/kg, p.o.) reduced the number of writhes. OS (50, 100 mg/kg, i.p.) also increased the tail withdrawal latency in mice. Naloxone (1 mg/kg, i.p.), an opioid antagonist, and DSP-4 (50 mg/kg, i.p.), a central noradrenaline depletor, attenuated the analgesic effect of OS in both the experimental models, whereas, PCPA (300 mg/kg, i.p.), a serotonin synthesis inhibitor, potentiated the action of OS on tail flick response in mice. The results of our study suggest that the analgesic action of OS is exerted both centrally as well as peripherally and involves an interplay between various neurotransmitter systems.

05
CLINICAL STUDY Current neuropharmacology (2023) PMID: 36797613 ↗
Herbal Therapeutics for Alzheimer's Disease: Ancient Indian Medicine System from the Modern Viewpoint.
Clinical Trial Synthesis 2023 Systematic Review published in Current neuropharmacology. Key conclusion: In this article Ayurveda, the ancient Indian herbal medicine system based on multiple clinical and experimental, evidence have been reviewed for treating AD and improving brain functioning.
View Original PubMed Abstract ↓

Alzheimer's is a chronic neurodegenerative disease where amyloid-beta (Aβ) plaques and neurofibrillary tangles are formed inside the brain. It is also characterized by progressive memory loss, depression, neuroinflammation, and derangement of other neurotransmitters. Due to its complex etiopathology, current drugs have failed to completely cure the disease. Natural compounds have been investigated as an alternative therapy for their ability to treat Alzheimer's disease (AD). Traditional herbs and formulations which are used in the Indian ayurvedic system are rich sources of antioxidant, anti-amyloidogenic, neuroprotective, and anti-inflammatory compounds. They promote quality of life by improving cognitive memory and rejuvenating brain functioning through neurogenesis. A rich knowledge base of traditional herbal plants (Turmeric, Gingko, Ashwagandha, Shankhpushpi, Giloy, Gotu kola, Garlic, Tulsi, Ginger, and Cinnamon) combined with modern science could suggest new functional leads for Alzheimer's drug discovery. In this article Ayurveda, the ancient Indian herbal medicine system based on multiple clinical and experimental, evidence have been reviewed for treating AD and improving brain functioning. This article presents a modern perspective on the herbs available in the ancient Indian medicine system as well as their possible mechanisms of action for AD treatment. The main objective of this research is to provide a systematic review of herbal drugs that are easily accessible and effective for the treatment of AD.

06
RANDOMIZED TRIAL (RCT) Frontiers in nutrition (2023) PMID: 37885445 ↗
Chronic supplementation of a multi-ingredient herbal supplement increases speed of cognitive task performance alongside changes in the urinary metabolism of dopamine and the gut microbiome in cognitively intact older adults experiencing subjective memory decline: a randomized, placebo controlled, parallel groups investigation.
Clinical Trial Synthesis 2023 Randomized Controlled Trial (RCT) published in Frontiers in nutrition involving n = 128 participants. Key conclusion: Reduced levels of Sutterella in the gut is associated with improved bowel movements of participants.
View Original PubMed Abstract ↓

BACKGROUND: The effects of herbs on brain function are often investigated in isolation, yet herbal preparations are often complex combinations of phytochemicals, designed to target widespread mechanisms. OBJECTIVE: To assess the effects of chronic, 12 weeks, supplementation of a multi-ingredient herbal supplement (containing Bacopa monnieri, Gotu kola leaf, Turmeric whole powder, Reishi full spectrum, Rosemary, Cardamom, Holy Basil, Turmeric Wholistic™ extract, Green Tea & Seagreens) on cognitive function in older adults with subjective memory decline. Secondly, to investigate whether effects are underpinned by shifts in microbial composition and/or metabolism of the herbs. METHODS: Male and female participants (N = 128) aged between 55-75 years completed lab-based cognitive assessments, and provided stool and urine samples, at baseline and then following 90 days of multi-ingredient herb, or placebo, supplementation. RESULTS: Deficits in memory were observed in response to 90 days of multi-ingredient herbal supplement supplementation but the positive effects were all focused on speed of cognitive task performance, with an additional improvement in the false alarm rate on the rapid visual information processing task. These improvements coincided with an increased presence of tyrosine in the urinary metabolome and this may implicate the role of dopamine in these processing and/or motor speed increases. Finally, multi-ingredient herbal supplementation significantly reduced levels of 3 bacterial species in the gut microbiome and one of these, Sutterella, coincides with lower levels of constipation reported in the multi-ingredient herbal supplement condition. CONCLUSION: A multi-ingredient herbal supplement increases speed of cognitive task performance and increased metabolism of tyrosine suggests that this is modulated by increased dopaminergic activity. Reduced levels of Sutterella in the gut is associated with improved bowel movements of participants. Interpretation of the negative effects on memory are, however, stymied by an unequal randomization of participants into treatment groups pre- and post-COVID 19.Clinical trial registration: identifier NCT05504668.

07
CLINICAL STUDY Biomaterials (2023) PMID: 37262936 ↗
The potential role of the novel orodispersible film from rice polymer loaded with silkworm pupae hydrolysate and the combined extract of holy basil and ginger for the management of stroke with stress.
Clinical Trial Synthesis 2023 Clinical Study published in Biomaterials. Key conclusion: The results clearly showed that all doses of JP1 decreased the brain infarct volume, oxidative stress, inflammation, and apoptosis and improved neurological deficits.
View Original PubMed Abstract ↓

The prevalence of stroke under stress conditions is rising and the severity of stroke is increasing. Owing to the limitation of the current therapeutic strategy, a novel effective strategy for treating this condition is needed. In this study, we explored the neuroprotective effect of an orodispersible film derived from a rice polymer loaded with silkworm pupae and the combined extract of holy basil and ginger (JP1). Male Wistar rats weighing 200-250 g were administered JP1 at the doses of 1, 10, and 100 mg/kg BW 45 min prior to an exposure to a 6-h immobilization stress for 14 days. Permanent, occlusion of the right middle cerebral artery (MCAO) was performed, and JP1 was administered continually for 21 days after MCAO. Assessments of the brain infarction volume, oxidative stress, inflammation, and apoptosis in the cerebral cortex were carried out 24 h after MCAO. Neurological severity scores were also determined for the rats every 7 days after MCAO until the end of the study period. The results clearly showed that all doses of JP1 decreased the brain infarct volume, oxidative stress, inflammation, and apoptosis and improved neurological deficits. Therefore, JP1 is a potential novel neuroprotective supplement for combating ischemic stroke under stress conditions. However, a clinical trial is essential to confirm this beneficial effect.

08
CLINICAL STUDY Poultry science (2011) PMID: 21177454 ↗
Effects of flaxseed, sardines, pearl millet, and holy basil leaves on production traits of layers and fatty acid composition of egg yolks.
Clinical Trial Synthesis 2011 Clinical Study published in Poultry science. Key conclusion: Holy basil leaf meal is a good feed supplement for increasing the yolk α-linolenic acid level by reducing the yolk saturated fatty acid levels proportionately.
View Original PubMed Abstract ↓

The effects of flaxseed, sardines, pearl millet, and holy basil (Oscimum sanctum) leaf meal on Single Comb White Leghorn (Forsgate strain) layer hen production traits, fatty acid composition of egg yolks, and egg quality characteristics were studied. Layer hens were allocated to 1 of 6 dietary treatments from 27 to 32 wk of age: control (treatment 1), control + 1 g of basil leaf meal (BLM) (treatment 2), control + 2 g of BLM (treatment 3), designer egg layer mash (DELM; treatment 4), DELM + 1 g of BLM (treatment 5), DELM + 2 g of BLM (treatment 6). No significant differences were found in egg production between dietary treatments, indicating that neither the designer diet nor the BLM had an adverse effect on egg production. The high energy level in the designer diet, because of the flaxseed oil and sardines, significantly reduced feed intake compared with the control diet. The egg weight was significantly higher in birds fed the designer diet compared with the egg weight in the control diet. The flaxseed oil and sardine oil, which are rich in n-3 polyunsaturated fatty acids, contributed to significantly increased n-3 polyunsaturated fatty acid levels in the egg yolks, with a proportionate reduction in the level of palmitic acid. Other fatty acids showed only minor variations. Flaxseed oil increased the level of α-linolenic acid, whereas fish oil increased the eicosapentaenoic acid and docosahexaenoic acid levels. The BLM at low levels of inclusion (1 and 2 g/kg) also contributed significantly to elevating the yolk n-3 polyunsaturated fatty acid levels, especially C18:3. Holy basil leaf meal is a good feed supplement for increasing the yolk α-linolenic acid level by reducing the yolk saturated fatty acid levels proportionately.

09
CLINICAL STUDY Alternative therapies in health and medicine (2010) PMID: 20232616 ↗
Antioxidants and antiinflammatory dietary supplements for osteoarthritis and rheumatoid arthritis.
Clinical Trial Synthesis 2010 Meta-Analysis published in Alternative therapies in health and medicine. Key conclusion: Whether any of these supplements can be effectively and safely recommended to reduce nonsteroidal antiinflammatory drug or steroid usage is unclear and requires more high-quality research.
View Original PubMed Abstract ↓

OBJECTIVE: To review efficacy studies of antioxidant and antiinflammatory dietary supplements used to manage osteoarthritis (OA) and rheumatoid arthritis (RA) and make conclusions about their place in therapy. Glucosamine, chondroitin, and methyl sulfonyl methane were excluded. DATA SOURCES: A literature search was conducted using MEDLINE (1996 through January 2009), EMBASE, Cochrane Library, Natural Medicines Comprehensive Database, and Natural Standard, with bibliographic review of relevant articles. Cited studies from before our search range were included if they represented the only published human data available. Search words included "antioxidant," "antiinflammatory," "cat's claw," "ginger," "fish oil," "omega-3," "turmeric," "vitamin E," "vitamin C," "Baikal skullcap," "barberry," "Chinese goldthread," "green tea," "Indian holy basil," "hu zhang,""oregano," and"rosemary." STUDY SELECTION AND DATA EXTRACTION: Efficacy studies published in English were included provided they evaluated the dietary supplements in patients with OA or RA. DATA SYNTHESIS: Our search strategy yielded 16 clinical studies (11 randomized, placebo-controlled clinical trials, three crossover trials, one case-controlled study, and one open-label study) in addition to one meta-analysis and one review article. CONCLUSIONS: Three studies support cat's claw alone or in combination for OA, and two studies support omega-3 fatty acids for the treatment of RA. We cannot recommend use of vitamin E alone; vitamins A, C, and E in combination; ginger; turmeric; or Zyflamend (New Chapter, Brattleboro, Vermont) for the treatment of OA or RA or omega-3 fatty acids for OA. Whether any of these supplements can be effectively and safely recommended to reduce nonsteroidal antiinflammatory drug or steroid usage is unclear and requires more high-quality research.

10
RANDOMIZED TRIAL (RCT) Trials (2026) PMID: 41656269 ↗
Effects of multi-herb and ashwagandha root formulas on stress modulation: a randomized, double-blind, placebo-controlled clinical study.
Clinical Trial Synthesis 2026 Randomized Controlled Trial (RCT) published in Trials; statistical significance reported at p = 0.0001. Key conclusion: CONCLUSION: The study concluded that both VL-G-A5
View Original PubMed Abstract ↓

BACKGROUND: Chronic stress is detrimental to the maintenance of the main response system - the hypothalamic-pituitary-adrenal (HPA) axis. The current study aimed to investigate the efficacy of two plant-based adaptogens, a formula containing Rhodiola, holy basil and Schisandra chinensis (VL-G-A57) and a full-spectrum ashwagandha (VL-G-E12), on stress and related symptoms in individuals with high stress. MATERIALS AND METHODS: The 60-day randomized, double-blind, placebo-controlled clinical study included individuals aged between 18 to 65 years with a body mass index (BMI) of 18 to 29.9 kg/m2. One hundred eighty-six participants were randomized to one of the adaptogens, VL-G-A57 or VL-G-E12, or to placebo. The primary outcome was a reduction in stress levels. Secondary outcomes were changes in sleep quality, fatigue, restorative sleep, mental alertness, mood dysregulation, and anxiety. A priori power analysis determined the required sample size. Efficacy was assessed by comparing mean changes in the primary endpoint at days 30 and 60 using ANCOVA, with baseline values as covariates. Dunnett's post hoc test identified significant differences versus placebo, and within-group changes were evaluated using paired t-tests. Normality was assessed visually and via Shapiro-Wilk/Kolmogorov-Smirnov tests as needed. Secondary outcomes were analyzed similarly. Analyses were conducted using R (v4.0.5) and XLSTAT (v2021.3.1). RESULTS: At day 60, both VL-G-A57 and VL-G-E12 significantly reduced Perceived Stress Scale (PSS) scores compared to placebo (p < 0.0001). Sleep quality, as measured by the Pittsburgh Sleep Quality Index (PSQI), improved significantly in both adaptogen groups (VL-G-A57: p = 0.0008, VL-G-E12: p < 0.0001). This corresponded well with the Restorative Sleep Questionnaire-Weekly (RSQ-W) results in the two IP arms when compared with placebo (p < 0.0001). Additionally, mood dysregulation (VL-G-A57: p = 0.0454), anxiety (VL-G-A57: p = 0.0004, VL-G-E12: p = 0.0015), and stress levels (VL-G-A57-VL-G-E12: p < 0.0001) showed significant improvements compared to placebo. No differences in mental alertness were observed. CONCLUSION: The study concluded that both VL-G-A5

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