The American Herbal Pharmacopoeia®

AHP Research Update

September 8, 2026

Dear AHP Members,


This month’s quality papers include a study comparing British Pharmacopoeia and US Pharmacopoeia standards for ashwagandha (Withania somnifera), quality assessment protocols for Codonopsis Radix and Ocimum species, and a framework for detecting adulteration of Rhodiola. Research studies include three clinical trials on ashwagandha, including for sleep and fitness in the elderly, cardiorespiratory fitness, and skin and hair as related to health. Additional clinical studies include fenugreek for postpartum sleep and astragalus in patients undergoing chemotherapy for colon cancer, among others. Preclinically, we have included a study on triphala for renal protection in hyperuricemia. Safety studies this month also address ashwagandha, one in patients with stress and anxiety and one regarding teratogenic and abortifacient claims. We have also included a safety study on Scutellaria baicalensis, as well as an investigation comparing global pharmacovigilance requirements for natural health products.


Please note that to facilitate ease of use for our members, we are now providing a Summary for each included paper. As always, we will include a link to the paper along with the citation.


We hope you will find these studies worthwhile and helpful for building your safety and documentation files. Please let us know if you are interested in any specific herbs or ingredients and we will do our best to accommodate your needs.  


Sincerely,

 

Roy Upton, RH, DipAyu

President, American Herbal Pharmacopoeia®


QUALITY


A Comparison of British and US Pharmacopoeia Standards for Quality of Ashwagandha Dietary Supplements in Commerce


Quick Link: https://pubmed.ncbi.nlm.nih.gov/41386716/


Summary: A study using an HPLC-PDA method based on British Pharmacopoeia (BP) and United States Pharmacopoeia (USP) standards quantified three steroidal lactones (withaferin A, withanolide A, and withanoside IV) in ashwagandha samples and commercial products. Among the results, not only were differences found in steroidal lactones content, but 44% and 60% of products did not meet BP or USP standards, respectively, with 10 out of 25 samples meeting both standards. Two of the samples were root-derived with the rest of the samples containing undisclosed aerial parts, which contributed to the high failure rate.


Citation: Avula B, Katragunta K, Tatapudi KK, et al. Phytother Res. 2026 Aug;40(8):4833-4844. doi: 10.1002/ptr.70148. Epub 2025 Dec 12.


A Quantifiable Grading Standard for Codonopsis Radix Based on the Multidimensional Quality Evaluation System of Phenotype, Chemistry, and Bioactivity


Quick Link: https://pubmed.ncbi.nlm.nih.gov/42143989/


Summary: To provide a comprehensive quality assessment for Codonopsis Radix (CR), a system combining phenotypic traits, chemical components, and bioactivity was developed. Based upon this approach, 50 CR samples were classified into Grade 1 (excellent), Grade 2 (good), and Grade 3 (general) and then tested in immunosuppressed mice. A significant correlation was observed between grade and immunomodulatory activity with Grade 1 significantly enhancing body weight growth rate; increasing thymus and spleen indices; and regulating serum levels of IL-2, IL-6, and TNF-α.


Citation: Liu C-L, Chen J-M, Jiang Y, Li H-J. J Chromatogr B Analyt Technol Biomed Life Sci. 2026 Aug 1:1280:125125. doi: 10.1016/j.jchromb.2026.125125. Epub 2026 May 16.


Differentiation of Ocimum Species Using UV-Vis and FTIR Spectroscopic Fingerprinting Combined with Chemometrics


Quick Link: https://pubmed.ncbi.nlm.nih.gov/42636429/


Summary: Spectroscopic fingerprint methods (ultraviolet-visible [UV-Vis] and Fourier Transform Infra-red [FTIR] spectroscopy) combined with chemometrics was developed to distinguish among Ocimum basilicum L., O. basilicum L. forma citratum Back., and O. sanctum L. species. UV-Vis spectroscopy exhibited partial overlap among species, resulting in 78.98% classification accuracy, while FTIR spectroscopy enabled clear species differentiation with 100% classification accuracy.


Citation: Suzery M, Nurauliya AH, Wibawa PJ, et al. Nat Prod Res. 2026 Aug 24:1-6. doi: 10.1080/14786419.2026.2720787. Online ahead of print.


Adulteration Prevention-Oriented Systematic Review of Chemical Constituents in the Genus Rhodiola and Strategic Outlook for Species Identification Based on Chemical Constituents


Quick Link: https://pubmed.ncbi.nlm.nih.gov/42657013/


Summary: To address adulteration of Rhodiola in the marketplace, Li et al. (2026) provided a comprehensive overview and classification of more than 500 phytochemicals in the genus, while qualitatively delineating interspecific chemical similarities and differences. Furthermore, the authors offered a hierarchical "chemical characteristics + classification tree" framework for stepwise identification along with a strategical plan for utilizing such an approach.


Citation: Li J, Sun X, Li G. Front Pharmacol. 2026 Aug 12:17:1872755. doi: 10.3389/fphar.2026.1872755. eCollection 2026.


RESEARCH


Ashwagandha (Withania somnifera) Root Extract Improves General Health in Elderly Men and Women: A Prospective, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study


Quick Link: https://pubmed.ncbi.nlm.nih.gov/41725116/


Summary: An 8-week, randomized, double-blind study with 50 healthy adults aged 60 to 85 years investigated the effects of ashwagandha (Withania somnifera) root extract (300 mg twice daily) on quality of life based upon the Older People's Quality of Life (OPQOL) questionnaire, as well sleep based upon the Epworth Sleepiness Scale (ESS) and fitness based upon the Senior Fitness Test (SFT). Significant improvements were seen in all three parameters compared to placebo. No adverse events were reported, with the extract reported to have good to excellent tolerability.


Citation: Honnutagi R, Ingale A, Naikawdi A. Phytother Res. 2026 Aug;40(8):4932-4945. doi: 10.1002/ptr.70125. Epub 2026 Feb 22.


Efficacy and Safety of Low-Dose Ashwagandha Supplementation on Exercise Endurance: A Randomized, Placebo-Controlled, Double-Blind, Clinical Trial


Quick Link: https://pubmed.ncbi.nlm.nih.gov/41846233/


Summary: In a randomized, double-blind, placebo-controlled study (N=66), a low dose (30 mg/day) of an ashwagandha root extract (Ashwa.30) standardized to withanolides (> 15% w/w) and an ATP-active fraction (> 15% w/w) was assessed for effects on cardiorespiratory fitness and exercise-induced fatigue in healthy individuals aged 18-45 years. The extract was shown to significantly and safely improve maximal oxygen consumption (VO2max), a gold standard parameter for aerobic fitness via the Modified Bruce Protocol Treadmill Test and maximal heart rate, along with lower lactic acid levels during exercise. In addition, creatine phosphokinase levels were significantly reduced, while Rating of Perceived Exertion and fatigue scores improved.


Citation: Prajapati H, Satia M, Shah D, et al. Phytother Res. 2026 Aug;40(8):4978-4987. doi: 10.1002/ptr.70178. Epub 2026 Mar 17.


A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Study of Efficacy and Safety of Ashwagandha Root Extract Capsule on Skin and Hair Health in Healthy Adults


Quick Link: https://pubmed.ncbi.nlm.nih.gov/41770039/


Summary: Taking health into consideration, including psychological effects along with associations with stress, inflammation, and the immune system, the potential benefits of ashwagandha on hair loss and skin conditions were investigated in a randomized double-blind study with healthy male and female subjects aged 18 to 60 years (N=92). After receiving ashwagandha extract (KSM‐66) capsules (300 mg 2x/day) for 75 days, significant improvements were seen in transepidermal water loss (TEWL) and hair-related parameters (density, growth, anagen, telogen, and anagen: telogen ratio), as well as quality of life measures, compared to placebo. No adverse effects were reported.


Citation: Jillella A, Keerthi N, Reddy JV. Phytother Res. 2026 Aug;40(8):4946-4959. doi: 10.1002/ptr.70199.


The Effect of Fenugreek Oral Capsule on the Sleep Quality of Primiparous Women in the Postpartum Period: A Triple‑Blind Randomized Controlled Trial


Quick Link: https://pubmed.ncbi.nlm.nih.gov/42547874/


Summary: A randomized, triple-blind, placebo-controlled study assessed the effects of fenugreek seed extract (700 mg/day starting on postpartum day 3,4, or 5 and continuing until day 60) on sleep based upon the Pittsburgh Sleep Quality Index (PSQI). While sleep quality scores were significantly different between the intervention and control groups at the start of the study and at day 15 postpartum, average sleep quality scores were significantly better at 30 and 60 days postpartum in the fenugreek group when adjusting for baseline differences.


Citation: Mohammadi S, Karimi FZ, Salari R, Mazloom SR. Matern Health Neonatol Perinatol. 2026 Aug 4;12(1):32. doi: 10.1186/s40748-026-00281-8.


The Effect of Astragalus membranaceus on Gut Microbiota and Chemotherapy Related Complications in Patients with Colon Cancer Undergoing Chemotherapy


Quick Link: https://pubmed.ncbi.nlm.nih.gov/42437336/


Summary: A study with 86 colon cancer patients (stages II, III, and IV) undergoing chemotherapy (bevacizumab combined with oxaliplatin and capecitabine) who also received astragalus (Astragalus membranaceus) granules (4 g/bag, 3 times/day, orally in water) determined effects of the intervention on intestinal flora and inflammation. Results showed astragalus to significantly increase intestinal Bifidobacterium and Lactobacillus and to reduce the content of Enterococcus and Escherichia coli. In addition, serum CD4+ T cells were significantly increased while CD8+ T cells significantly decreased, effects associated with lowered inflammatory states.


Citation: Zhang B, Lin H, Zhang J, et al. Pak J Pharm Sci. 2026 Sep;39(9):2919-2927. doi: 10.36721/PJPS.2026.39.9.270.1.


Nigella sativa (Black Seed) Oil Alleviates the Serum Levels of IL-6 and Insulin in Patients with Polycystic Ovary Syndrome


Quick Link: https://pubmed.ncbi.nlm.nih.gov/42601227/


Summary: A 12-week, randomized, double-blind, placebo-controlled trial (N=60) showed Nigella sativa oil (1,000 mg/day) to significantly decrease serum IL-6 and fasting blood glucose in women with polycystic ovary syndrome. However, no significant differences were observed for fasting insulin, Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), Quantitative Insulin Sensitivity Check Index (QUICKI), luteinizing hormone, or total testosterone between groups.


Citation: Jamshidian S, Jalilvand F. Obstet Gynaecol Res. 2026 Aug;52(8):e70442. doi: 10.1111/jog.70442.


Aromatherapy Effects on Pain and Anxiety during Transrectal Ultrasound-Guided Prostate Biopsy: A Randomized Controlled Trial


Quick Link: https://pubmed.ncbi.nlm.nih.gov/42302879/


Summary: In a randomized placebo-controlled study to determine potential benefits of the administration via nebulizer of lavender or frankincense aromatherapy in 120 male patients while undergoing transrectal ultrasound-guided prostate biopsy, primary outcomes included changes in anxiety levels according to the State Anxiety Inventory (STAI-I) and pain intensity according to the Visual Analog Scale (VAS). Significant beneficial effects were seen in anxiety and pain measures with both lavender and frankincense, with no adverse events.


Citation: Saylam B, Nebioglu A, Aydinli B, et al. Complement Ther Med. 2026 Sep:100:103396. doi: 10.1016/j.ctim.2026.103396. Epub 2026 Jun 16.


Triphala Ameliorates Hyperuricemia-Associated Nephropathy by Modulating the Gut Microbiota-Glycerophospholipid-TLR4 Axis


Quick Link: https://pubmed.ncbi.nlm.nih.gov/42600364/


Summary: In a mouse model of hyperuricemia, triphala aqueous extract dose-dependently reduced serum uric acid, improved renal function by lowering serum creatinine (Cr) and blood urea nitrogen (BUN) levels, increased the fractional excretion of uric acid (FEUA), and alleviated tubular injury and fibrosis. The renal protective effects were associated with changes in gut microbiota, including reversing dysbiosis by suppressing opportunistic pathogens (e.g. Parasutterella and Allobaculum) and enriching those that are beneficial (e.g. Bifidobacterium and Akkermansia).


Citation: Liu C, Zhang H, Zhang H, et al. Phytomedicine. 2026 Aug 6:160:158694. doi: 10.1016/j.phymed.2026.158694. Online ahead of print.


SAFETY


Safety of 8-Week Administration with Ashwagandha (Withania somnifera) Root Extract in Adults with Stress and Anxiety: Findings from a Prospective, Randomized, Multi-Center, Double-Blinded, Placebo-Controlled Study


Quick Link: https://pubmed.ncbi.nlm.nih.gov/41943502/


Summary: An 8-week, randomized, double-blind, placebo-controlled study with 1,002 healthy adults reporting stress and anxiety investigated the safety and tolerability of oral ashwagandha (Withania Somnifera) (600 mg/day). No serious adverse events were reported with a total of 74 adverse events (46 in the placebo group and 28 in the ashwagandha group), most commonly nausea, dry mouth, and headache. No significant changes were observed in liver function tests, renal function markers, or hematological parameters between groups. No significant differences between groups were seen in tolerabilty as determined by the Global Assessment of Tolerability to Therapy scale with most in the ashwagandha group rating it as “Good” or “Excellent.”


Citation: Pakhale K, Salve J, Ademola J, et al. Phytother Res. 2026 Aug;40(8):5005-5015. doi: 10.1002/ptr.70315. Epub 2026 Apr 6.


A Systematic and Ethnobotanical Review of Ashwagandha's (Withania Somnifera) Teratogenic and Abortifacient Potentials


Quick Link: https://pubmed.ncbi.nlm.nih.gov/40887707/


Summary: A comprehensive review based upon PRISMA guidelines was conducted to critically address ashwagandha teratogenic and abortifacient claims regarding reproductive toxicity, molecular interactions, and traditional usage. According to the reviewers, while ethnobotanical reports suggest potential abortifacient effects, the validity of such claims needs to be questioned due to citation distortion and lack of primary source validation. Based upon animal studies, no significant reproductive toxicity has been observed at doses relevant to human consumption, while human clinical studies show no adverse effects on thyroid function, hormonal balance, or reproductive health. Overall, the authors concluded that evidence for teratogenic or abortifacient activity remains inconclusive with standardized high-quality research in controlled conditions needed.


Citation: Tallon MJ, Koturbash I, Blum JL. Phytother Res. 2026 Aug;40(8):4737-4758. doi: 10.1002/ptr.70079. Epub 2025 Aug 31.


ABCB1 rs2032582 as a Potential Biomarker for Predicting Scutellaria baicalensis Georgi-Drug Induced Liver Injury in Humans


Quick Link: https://pubmed.ncbi.nlm.nih.gov/42665171/


Summary: In an attempt to address potential Scutellaria baicalensis (SBG)-related herb-induced liver injury, including a dose-dependent toxicity pattern and pharmacogenomic biomarkers of genetic susceptibility (specifically ABCB1 polymorphisms), two multicenter studies in the Chinese Han population were investigated. In the retrospective study (1,928,526 outpatients), a relationship between SBG dosage, treatment duration and hepatotoxicity risk were analyzed. A screening in 12 patients with SBG-related drug-induced liver injury utilized single-nucleotide polymorphism (SNP) and genotyping for genetic susceptibility. Results showed a dose-toxicity relationship with daily doses exceeding the pharmacopoeia recommendation (>10 g/day) significantly increasing the risk of liver injury. Furthermore, the ABCB1 rs2032582 variant was identified as a genetic susceptibility in the Chinese Han population.


Citation: Fu L, Ji L, Zhu W, et al. J Ethnopharmacol. 2026 Aug 28:122329. doi: 10.1016/j.jep.2026.122329. Online ahead of print.


Pharmacovigilance Regulatory Requirements for the Natural Health Products (NHPs) Industry in World Health Organization-Defined High Health Expenditure Countries (2020): A Scoping Review


Quick Link: https://pubmed.ncbi.nlm.nih.gov/42050312/


Summary: A study compared the pharmacovigilance requirements for natural health products (NHP) in the top 30 countries/regions from the World Health Organization's (WHO) list of nations with the highest Current Health Expenditure in 2020; regulatory documents from 12 countries/regions were included (i.e. Australia, Brazil, Canada, China, India, Japan, Republic of Korea, South Africa, Switzerland, UK, USA. and the EU). The investigation showed that pharmacovigilance requirements vary both between and within countries and regions, as well as in jurisdictions that apply separate medicine- and food-based primary legislation to different NHP categories. While the focus is on serious adverse drug reactions (ADR), requirements for submitting foreign ADR reports, periodic safety update reports, conducting literature screening, and employing a Qualified Person for Pharmacovigilance also vary.


Citation: Lim XY, Ram S, Scahill S, Barnes J. Drug Saf. 2026 Sep;49(9):1023-1043. doi: 10.1007/s40264-026-01674-6. Epub 2026 Apr 28.

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