NICEVIVA
MONOGRAPH SPEC LATEST 2025

Banaba Leaf

BOTANICALS · Evidence Monograph

Banaba Leaf is an evidence-graded botanicals monograph evaluated across 15 peer-reviewed PubMed studies (0 meta-analyses, 0 systematic reviews, and 1 randomized controlled trials, encompassing n = 68 cumulative participants). Current clinical evidence is rated GRADE Low (2.0 / 4.0) for phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways.

Evidence Grade (GRADE) Low (2.0 / 4.0)
Indexed PubMed Studies 15 Studies
Meta-Analyses · Reviews 0 Meta · 0 Systematic Reviews
Randomized Trials (RCT) 1 RCTs (1 Double-Blind)
Cumulative Participants n = 68
Reported Trial Dosages 200 g · 12.87 μg · 3.19 μg
Trial Duration Range 12 weeks · 6 weeks · 14 days
Reading Time ~8 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 15 indexed PubMed studies, GRADE Low).
  2. 02 Adults matching clinical trial dosing protocols (200 g · 12.87 μg · 3.19 μg) over a structured 12 weeks 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
cholesterol (PubMed clinical endpoint)
kidney (PubMed clinical endpoint)
liver (PubMed clinical endpoint)
diabetes (PubMed clinical endpoint)
01

What Is Banaba Leaf & Why Does Form Matter?

Banaba Leaf is classified under BOTANICALS and has been investigated across 15 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 (200 g, 12.87 μg, 3.19 μg).

02

Who Benefits Most & Common Depletion Factors

Suboptimal status or increased physiological demand for Banaba Leaf 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 (1 RCTs indexed) rather than generalized marketing claims.

03

Physiological Mechanism of Action

Within human physiology, Banaba Leaf 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 Banaba Leaf an overall evidence rating of GRADE Low (2.0 / 4.0) based on 15 PubMed studies: 0 meta-analyses, 0 systematic reviews, and 1 randomized controlled trials (1 double-blind, n = 68 total participants).

Representative peer-reviewed findings include: • PMID:33167849 (2021) — "Evaluation of a Nutraceutical Product with Probiotics, Vitamin D, Plus Banaba Leaf Extracts (Lagerstroemia speciosa) in Glycemic Control." (CONCLUSION: Probiotics may help correct defects in the gut microbial environment improving metabolic parameters, such as blood sugar levels, glycosylated hemoglobin and a decrease in body weight.) • PMID:40868990 (2025) — "Co-Supplementation of Policosanol and Banaba Leaf Extract Exhibited a Cooperative Effect Against Hyperglycemia and Dyslipidemia in Zebrafish: Highlighting Vital Organ Protection Against High-Cholesterol and High-Galactose Diet." (Likewise, BLE+POL effectively reduced blood malondialdehyde (MDA), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) levels and boosted plasma sulfhydryl content, ferric ion reduction ability (FRA), and paraoxonase (PON) activity.) • PMID:40613623 (2025) — "Exploring nutraceutical solutions for prediabetes: a narrative review on the effects of banaba and chromium picolinate." (In conclusion, nutraceuticals like CrP and banaba leaf extract hold promise as complementary therapies to be used alongside lifestyle modifications for individuals with prediabetes.)

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 200 g · 12.87 μg · 3.19 μg · 2.94 μg over 12 weeks · 6 weeks · 14 days · 30 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 Banaba Leaf, 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 (200 g · 12.87 μg · 3.19 μg) and re-evaluate efficacy after 12 weeks.
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 (15 Studies) · 4 Quantitative Analyses

01
CLINICAL STUDY Endocrine, metabolic & immune disorders drug targets (2021) PMID: 33167849 ↗
Evaluation of a Nutraceutical Product with Probiotics, Vitamin D, Plus Banaba Leaf Extracts (Lagerstroemia speciosa) in Glycemic Control.
Clinical Trial Synthesis 2021 Clinical Study published in Endocrine, metabolic & immune disorders drug targets. Key conclusion: CONCLUSION: Probiotics may help correct defects in the gut microbial environment improving metabolic parameters, such as blood sugar levels, glycosylated hemoglobin and a decrease in body weight.
View Original PubMed Abstract ↓

BACKGROUND: Dysbiosis is related to changes in the composition and behaviour of intestinal microbiota, which may contribute to an age-related decline in metabolic and immune system functioning (immune-senescence). OBJECTIVE: The microbiota-targeted dietary and probiotic interventions have been shown to favorably affect the host health by an enhancement of antioxidant activity, improving immune homeostasis, suppression of chronic inflammation, regulation of metabolism and prevention of insulin resistance. RESULTS: In our study, the use of specific probiotics strains improved the serum concentration of glycemic markers, thereby promoting better overall health. CONCLUSION: Probiotics may help correct defects in the gut microbial environment improving metabolic parameters, such as blood sugar levels, glycosylated hemoglobin and a decrease in body weight.

02
CLINICAL STUDY International journal of molecular sciences (2025) PMID: 40868990 ↗
Co-Supplementation of Policosanol and Banaba Leaf Extract Exhibited a Cooperative Effect Against Hyperglycemia and Dyslipidemia in Zebrafish: Highlighting Vital Organ Protection Against High-Cholesterol and High-Galactose Diet.
Clinical Trial Synthesis 2025 Clinical Study published in International journal of molecular sciences. Key conclusion: Likewise, BLE+POL effectively reduced blood malondialdehyde (MDA), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) levels and boosted plasma sulfhydryl content, ferric ion reduction ability (FRA), and paraoxonase (PON) activity.
View Original PubMed Abstract ↓

The efficacy of Lagerstroemia speciosa (banaba) leaf extract (BLE), policosanol (POL), and their combination (BLE+POL) was evaluated in zebrafish (Danio rerio) against high cholesterol (HC)- and galactose (HG)-induced metabolic stress and organ toxicity. After 12 weeks of dietary intervention, BLE+POL significantly reduced HC+HG-augmented weight gain and improved hepatic and nephromegaly. Compared with BLE or POL alone, the combined intake of BLE+POL more effectively alleviated dyslipidemia and blood glucose levels. Likewise, BLE+POL effectively reduced blood malondialdehyde (MDA), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) levels and boosted plasma sulfhydryl content, ferric ion reduction ability (FRA), and paraoxonase (PON) activity. Histological outcomes suggest that BLE+POL has higher efficacy than either BLE or POL in mitigating HC+HG-induced fatty liver changes, hepatic inflammation, kidney senescence, and reactive oxygen species (ROS) production. Consistently, BLE+POL augmented the spermatozoa counts in the testes, enhanced mature vitellogenic oocytes in ovaries, and protected them from the HC+HG-induced oxidative stress. Compared with either BLE or POL, a combined intake of BLE+POL displayed a superior effect in inhibiting the apoptosis and accumulation of lipid peroxidation species 4-hyrdoxynonenal (4-HNE) in the brain. A combined intake of BLE+POL exhibited a pronounced impact than the BLE and POL alone and can be utilized as an effective formulation to counteract the HC+HG-induced events.

03
CLINICAL STUDY European review for medical and pharmacological sciences (2025) PMID: 40613623 ↗
Exploring nutraceutical solutions for prediabetes: a narrative review on the effects of banaba and chromium picolinate.
Clinical Trial Synthesis 2025 Clinical Study published in European review for medical and pharmacological sciences. Key conclusion: In conclusion, nutraceuticals like CrP and banaba leaf extract hold promise as complementary therapies to be used alongside lifestyle modifications for individuals with prediabetes.
View Original PubMed Abstract ↓

Prediabetes is an intermediary metabolic state marked by impaired glucose control, often preceding the development of type 2 diabetes (T2D). Early detection of prediabetes and intervention are critical to prevent the progression to T2D and its associated complications. This review examines the effects of nutraceuticals on regulating metabolism, with a focus on glucose control, specifically chromium picolinate (CrP) and banaba leaf extract. CrP has been extensively studied, and its role in regulating metabolism has been officially recognized. Preclinical research demonstrates its ability to improve glucose control by enhancing insulin sensitivity. These effects explain the reductions in fasting plasma glucose, elevated hemoglobin A1c, and insulin levels observed in clinical studies, particularly in patients with T2D. Banaba (Lagerstroemia speciosa) leaf extract, rich in corosolic acid and ellagitannins, has also shown promising results in improving glycemic control. As observed in preclinical studies, both banaba extract and corosolic acid exert insulin-sensitizing, glucose-lowering, and lipid-lowering properties. Clinical trials have confirmed these effects in individuals with T2D and prediabetes. Based on this evidence, combining CrP and banaba leaf extract may offer synergistic benefits in managing dysglycemia and delaying the onset of T2D in individuals with prediabetes. Only one study has evaluated the effects of the CrP and banaba extract combination, showing positive outcomes in individuals with prediabetes. Further research is needed to corroborate these preliminary findings. In conclusion, nutraceuticals like CrP and banaba leaf extract hold promise as complementary therapies to be used alongside lifestyle modifications for individuals with prediabetes. GRAPHICAL ABSTRACT: https://www.europeanreview.org/wp/wp-content/uploads/Graphical-Abstract-1-1-scaled.jpg.

04
CLINICAL STUDY Pharmaceuticals (Basel, Switzerland) (2025) PMID: 40573255 ↗
Synergistic Effect of Banaba Leaf Extract and Policosanol (Raydel(®)) Ameliorate High Cholesterol and High Galactose-Diet Induced Adverse Events in Zebrafish.
Clinical Trial Synthesis 2025 Clinical Study published in Pharmaceuticals (Basel, Switzerland) involving n = 28 participants; statistical significance reported at p = 0.01. Key conclusion: Conclusions: The findings highlight the synergistic effects of the BNB and PCO combination to mitigate the adversity posed by the consumption of the HC+HG diet.
View Original PubMed Abstract ↓

Background: This study aimed to explore the therapeutic potential of a dietary regimen of banaba leaf extract (BNB), policosanol (PCO, Raydel®), and their combination (BNB+PCO), to mitigate high cholesterol (HC) and high galactose (HG) diet-induced dyslipidemia, hyperglycemia, oxidative stress, senescence, and organ damage in zebrafish (Danio rerio). Methodology: Zebrafish (n = 28/group) were fed with HC (4% w/w)+HG (30% w/w) or HC+HG supplemented either with BNB (0.1% w/w) or PCO (0.1% w/w) or BNB+PCO (0.1% w/w each). Following 6 weeks of dietary intervention, biochemical and histopathological examinations across the groups were performed. Results: Post 6 weeks of consumption, the BNB+PCO group exhibited a significant 40% decrease in body weight (BW) relative to the BW of the HC+HG group, while the BNB or PCO groups displayed nonsignificant changes in BW. Both BNB and PCO reduced HC+HG-induced dyslipidemia and hyperglycemia; however, co-administration (BNB+PCO) demonstrated a significantly greater therapeutic effect in countering these conditions compared to either BNB or PCO alone. A similar effect of the BNB+PCO combination was observed on the elevation of plasma sulfhydryl content, paraoxonase (PON), and ferric ion reduction activity (FRA), with notably ~1.2-times (p < 0.01) higher levels compared to their corresponding values observed in the BNB or PCO groups. Significantly diminished plasma AST, ALT, hepatic interleukin 6 (IL-6) levels, and fatty liver changes were observed in response to BNB+PCO, compared to either BNB or PCO alone. Also, BNB+PCO displayed a higher curative effect against HC+HG-induced impairment of tissue regeneration than BNB or PCO alone. A notable effect of BNB+PCO was perceived in protecting kidneys, testis, and ovary damage. Consistently, BNB+PCO showed a profound impact on mitigating HC+HG elevated reactive oxygen species (ROS) generation, apoptosis, cellular senescence, and accumulation of brain-binding lipid proteins (BLBPs) and 4-hydroxynoneal (4-HNE) in the brain. Conclusions: The findings highlight the synergistic effects of the BNB and PCO combination to mitigate the adversity posed by the consumption of the HC+HG diet.

05
CLINICAL STUDY Pharmaceuticals (Basel, Switzerland) (2025) PMID: 40143139 ↗
Synergistic Efficacy of Policosanol (Raydel(®)) and Banaba Leaf Extract to Treat Hyperglycemia and Dyslipidemia in Streptozotocin-Induced Diabetic and Hyperlipidemic Zebrafish (Danio rerio): Protection of Liver and Kidney with Enhanced Tissue Regeneration.
Clinical Trial Synthesis 2025 Clinical Study published in Pharmaceuticals (Basel, Switzerland); statistical significance reported at p = 0.05. Key conclusion: Histological analyses revealed a significant effect of BNB+
View Original PubMed Abstract ↓

Background: The efficacy of banaba leaf extract was tested against carboxymethyllysine (CML)-induced toxicity in embryos and adult zebrafish. Additionally, the individual and combined effects of banaba (BNB) and policosanol (PCO) were analyzed to alleviate dyslipidemia, hyperglycemia, and associated effects in streptozotocin (STZ)-induced hyperlipidemic diabetic zebrafish. Methodology: The high cholesterol diet (HCD, final 4%, w/w)-fed zebrafish were injected with STZ to develop diabetes and were subsequently fed with either HCD or HCD+BNB (final 0.1% w/w) or HCD+PCO (final 0.1% w/w) or HCD+BNB+PCO (each final 0.1%, w/w) each for 14 days. The zebrafish tail fin was amputated to assess tissue regeneration, while the organs and blood were collected for histological and biochemical analysis. Results: Severely compromised embryo survivability and developmental defects were noticed in the CML-injected group that significantly improved following BNB exposure. Similarly, CML-induced acute paralysis and mortality of adult zebrafish were effectively mitigated by the treatment with BNB. In the hyperlipidemic diabetic zebrafish, both BNB and PCO supplementation displayed the hypoglycemic effect; however, a remarkable reduction (p < 0.05) in blood glucose levels was observed in the BNB+PCO group, around 14% and 16% less than the BNB group and PCO group, respectively. Likewise, higher tail fin regeneration was noticed in response to BNB+PCO supplementation. Both BNB and PCO have a substantial counter-effect against HCD+STZ-induced dyslipidemia. However, the combined supplementation (BNB+PCO) displayed a significantly better effect than that of BNB and PCO alone to alleviate total cholesterol (TC), triglycerides (TGs), and low-density lipoprotein cholesterol (LDL-C). The most impressive impact of BNB+PCO was noticed in the elevation of high-density lipoprotein cholesterol (HDL-C), which was ~1.5 times higher than the HDL-C level in response to BNB and PCO. Also, BNB+PCO effectively reduced the malondialdehyde (MDA) and elevated the plasma sulfhydryl content, paraoxonase (PON), and ferric ion reduction (FRA) activity. Histological analyses revealed a significant effect of BNB+

06
CLINICAL STUDY Microorganisms (2024) PMID: 39338524 ↗
Identification of Bioactive Substances Derived from the Probiotic-Induced Bioconversion of Lagerstroemia speciosa Pers. Leaf Extract That Have Beneficial Effects on Diabetes and Obesity.
Clinical Trial Synthesis 2024 Clinical Study published in Microorganisms. Key conclusion: This implies that the consumption of a probiotic should be encouraged for people undergoing BLE treatment to improve its anti-diabetic effects.
View Original PubMed Abstract ↓

Lagerstroemia speciosa L. (Banaba) has been used as a functional food because of its diuretic, decongestant, antipyretic, anti-hyperglycemic, and anti-adipogenic activities. Triterpene acids, including corosolic acid, oleanolic acid, and asiatic acid, are the principal phytochemicals in Banaba and are potentially anti-diabetic substances, owing to their effect on blood glucose concentration. Bioconversion of Banaba leaf extract (BLE) by Lactobacillus plantarum CBT-LP3 improved the glucose uptake, insulin secretion, and fat browning of this functional food. Furthermore, we identified asiatic acid, which was found to be increased by 3.8-fold during the L. plantarum CBT-LP3-mediated bioconversion process using metabolite profiling. Most previous studies have focused on corosolic acid, another triterpene acid that is a known anti-diabetic compound and is used to standardize BLE preparations. However, asiatic acid is the second most common of the triterpene acids and is also well known to have anti-diabetic properties. The present study has provided strong evidence that asiatic acid represents an alternative to corosolic acid as the most important active compound. These results suggest that the probiotic-mediated bioconversion of BLE may improve the anti-diabetic effects of this functional food. This implies that the consumption of a probiotic should be encouraged for people undergoing BLE treatment to improve its anti-diabetic effects.

07
CLINICAL STUDY Cureus (2024) PMID: 38313882 ↗
Lagerstroemia speciosa Pers. (Lythraceae) Ethanolic Extract Attenuates Isoniazid-Induced Oxidative Stress and Hepatic Inflammation in Rats.
Clinical Trial Synthesis 2024 Clinical Study published in Cureus. Key conclusion: Conclusion The results of this study suggest that EBLE can be used for INH-induced hepatotoxicity.
View Original PubMed Abstract ↓

Background Drug-induced liver injury is a common cause of acute liver failure. Isoniazid (INH) is used as a first-line treatment for tuberculosis. Clinical and experimental studies have reported abnormal liver function after INH therapy. Lagerstroemia speciosa Pers., commonly known as banaba, has been traditionally used to treat various ailments including diabetes and obesity due to its antioxidant and anti-inflammatory properties. Aim To investigate the hepatoprotective effect of ethanolic banaba leaf extract (EBLE) against INH-induced hepatotoxicity in rats. Materials and methods A total of 30 male Wistar albino rats (150 - 200 g) were divided into five groups (n = 6). Group I rats were served as a control and were administered dimethyl sulfoxide for the first 30 days and water for the next 30 consecutive days. Group II rats were administered INH (50 mg/kg, p.o.) once in the first 30 consecutive days and sacrificed at Day 30. Group III rats were administered INH for 30 consecutive days and left without treatment for the next 30 days. In Groups IV and V, rats were post-treated orally with EBLE 250 and 500 mg/kg, p.o. (0.3 ml/rat) for 30 days after INH administration. At the end of Day 60, the remaining group of animals were sacrificed. The blood and liver tissues were collected. The marker enzymes of hepatotoxicity, oxidative stress markers, inflammatory markers, and histopathology were analyzed. Results INH administration induced significant elevation of marker enzymes (aspartate transaminase, alanine transaminase, alkaline phosphatase, lactate dehydrogenase, bilirubin, gamma-glutamyl transpeptidase) of hepatotoxicity in the serum. This treatment also increased lipid peroxidation and proinflammatory marker expression (tumor necrosis factor-alpha, transforming growth factor-beta, and nuclear factor kappa B (NF-κB) except inhibitor of NF-κB) and decreased antioxidants such superoxide dismutase, catalase, and glutathione in the liver tissue. All these abnormalities were significantly mitigated after treatment with EBLE. Conclusion The results of this study suggest that EBLE can be used for INH-induced hepatotoxicity.

08
CLINICAL STUDY Environmental toxicology (2020) PMID: 32697429 ↗
Lagerstroemia speciosa (L.) Pers. triggers oxidative stress mediated apoptosis via intrinsic mitochondrial pathway in HepG2 cells.
Clinical Trial Synthesis 2020 Clinical Study published in Environmental toxicology. Key conclusion: EBLE treatments caused significant and concentration-dependent cytotoxicity and oxidative stress in HepG2 cells.
View Original PubMed Abstract ↓

Hepatocellular carcinoma is the second leading cause of cancer-related mortality worldwide. Lagerstroemia speciosa Pers. (Lythraceae) commonly known as Banaba has been used in different forms in traditional medicinal systems for treating various diseases which include diabetes and obesity. In this study, we investigated the cytotoxic potential of ethanolic Banaba leaf extract (EBLE) in HepG2 cells. The phytochemical analysis of EBLE was performed by HPTLC. HepG2 cells were treated with EBLE at 25, 50, 100, and 150 μg/mL concentrations, and cytotoxicity was evaluated by MTT assay. Oxidative stress was assessed by the evaluation of lipid peroxidation, superoxide dismutase, and reduced glutathione. Apoptosis-related morphology was investigated by acridine orange and ethidium bromide (AO/EB) dual staining. Mitochondrial membrane potential (ΔΨm) was evaluated by JC-1 staining. Apoptosis-related marker genes were evaluated by qPCR. HPTLC analysis confirmed the presence of corosolic acid (12.87 μg/mg), berberine (3.19 μg/mg), and gallic acid (2.94 μg/mg) in EBLE. EBLE treatments caused significant and concentration-dependent cytotoxicity and oxidative stress in HepG2 cells. Dual staining with AO/EB confirmed membrane distortion and nuclear chromatin condensation upon EBLE treatments. JC-I staining revealed the loss of ΔΨm. Furthermore, at a molecular level, EBLE treatments interfere with Bax/Bcl-2 homeostasis and induced the pro-apoptotic marker genes such as cytochrome c, Apaf-1, and caspases 9 and 3. EBLE treatments caused cytotoxicity in HepG2 cells, and this could be due to the induction of oxidative stress and apoptosis via the intrinsic or mitochondrial pathway. © 2020 Wiley Periodicals LLC.

09
RANDOMIZED TRIAL (RCT) Trials (2019) PMID: 30616613 ↗
Polyherbal dietary supplementation for prediabetic adults: study protocol for a randomized controlled trial.
Clinical Trial Synthesis 2019 Randomized Controlled Trial (RCT) published in Trials involving n = 40 participants. Key conclusion: Although the use of dietary and herbal supplements is popular worldwide, and a variety of single herbal medicines have been examined for glycemic management, the potential of increasingly common polyherbal formulations to return glycemic parameters to normal ranges among adults w
View Original PubMed Abstract ↓

BACKGROUND: Prediabetes describes a state of hyperglycemia outside of normal limits that does not meet the criteria for diabetes diagnosis, is generally symptomless, and affects an estimated 38% of adults in the United States. Prediabetes typically precedes the diagnosis of type 2 diabetes, which accounts for increased morbidity and mortality. Although the use of dietary and herbal supplements is popular worldwide, and a variety of single herbal medicines have been examined for glycemic management, the potential of increasingly common polyherbal formulations to return glycemic parameters to normal ranges among adults with prediabetes remains largely unexplored. The purpose of this study is to evaluate the efficacy of a commercially available, polyherbal dietary supplement on glycemic and lipid parameters in prediabetic individuals. METHODS: In this multi-site, double-blinded, randomized controlled clinical trial, 40 participants with prediabetes will be randomized to either a daily oral polyherbal dietary supplement (GlucoSupreme™ Herbal; Designs for Health®, Suffield, CT, USA; containing cinnamon bark (Cinnamomum cassia), banaba leaf (Lagerstroemia speciosa standardized to 1% corosolic acid), kudzu root (Pueraria lobata standardized to 40% isoflavones), fenugreek seed (Trigonella foenum-graceum standardized to 60% saponins), gymnema leaf (Gymnema sylvestre standardized to 25% gymnemic acid), American ginseng root (Panax quinquefolius standardized to 5% ginsenosides), and berberine HCl derived from bark (Berberis aristata)) or placebo for 12 weeks. Short-, medium-, and comparatively long-term markers of glycemic control (blood glucose and fasting insulin, fructosamine, and glycated hemoglobin/A1c, respectively), and other glycemic parameters (GlycoMark, β-cell function, and insulin sensitivity/resistance) will be obtained. Lipid profile (total cholesterol, LDL, HDL, and triglycerides), inflammation (hs-CRP), progression to type 2 diabetes mellitus, as well as safety indices (ALT, AST) will be obtained. An intention-to-treat analysis will be used to assess changes in study outcomes. DISCUSSION: Treatment options for adults with prediabetes are currently limited.

10
CLINICAL STUDY Biological trace element research (2017) PMID: 27854046 ↗
Fluoride Exposure Aggravates the Testicular Damage and Sperm Quality in Diabetic Mice: Protective Role of Ginseng and Banaba.
Clinical Trial Synthesis 2017 Clinical Study published in Biological trace element research. Key conclusion: However, the correlates showed moderate association between blood glucose levels and the spermatological as well as biochemical indices wherein the tissue fluoride levels correlate least.
View Original PubMed Abstract ↓

Fluoride toxicity is known to pose infertility in fluoride-intoxicated animals as well as in people residing in fluoride endemic zones. The present study addresses the degree of impairments caused due to co-exposure of high fluoride toxicity in diabetic mice. Swiss mice, Mus musculus, were subjected to fluoride toxicity by providing fluoride-supplemented drinking water (600 ppm NaF) for a period of 30 days after the confirmation of streptozotocin-induced diabetes(STZ, 50 mg/kgbw). Consequently, aggravated hyperglycemia and tissue fluoride accumulation were witnessed in fluoride-intoxicated diabetic mice; later, these toxicated mice were treated with ginseng extract (GE) and banaba leaf extract, (BLE) at dose of 150 mg/kgbw/day alone and in combination for 15 and 30-day duration to check the efficacy of phytoextracts in reversing the toxicity. The spermatological indices studied, such as sperm density, motility, viability and morphology as well as the testicular biochemical parameters showed enhanced impairment in reproductive status of fluoride-intoxicated diabetic mice. Further, 15-days administration of GE and BLE in combination at a dose of 150 mg/kgbw/day was found to be beneficial in normalizing the alterations observed upon fluoride intoxication to diabetic mice. However, the correlates showed moderate association between blood glucose levels and the spermatological as well as biochemical indices wherein the tissue fluoride levels correlate least.

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