ArticleJournal of Ayurveda and integrative medicine
Safety and pharmacokinetics of Withaferin-A in advanced stage high grade osteosarcoma: A phase I trial.
Article in Journal of Ayurveda and integrative medicine. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 53 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase II Clinical Trial of Standardized Withaferin-A for the Treatment of Steroid Refractory Acute Graft Versus Host Disease
A Phase I/II Trial to Assess Safety and Activity of Standardized Withaferin A as GvHD Prophylaxis in Patients Undergoing Matched Related Donor Hematopoietic Stem Cell Transplant
Who cites it
53 citing papers in PubMed, 90 citations in OpenAlex.
- Superior Bioavailability of a Novel 1.5% Ashwagandha Formulation (Zenroot™): A Randomized, Double-Blind, Single-Dose, Comparative, Oral Bioavailability Study in Healthy Adults.Advances in therapy · 2025Trial
- Neuroprotective Role of Withaferin A in Huntington's Disease: Current Evidence and Future Perspectives.Molecular neurobiology · 2026Review
- Plant Part-Specific Differences in Ashwagandha (Food science & nutrition · 2026Review
- Withaferin A, a candidate drug for lupus nephritis, confers renal protection via Pon1‑mediated attenuation of oxidative stress.International journal of molecular medicine · 2026Article
- Exploring the therapeutic potential of withaferin A by modulating key oncosignaling pathways.Naunyn-Schmiedeberg's archives of pharmacology · 2026Review
- Modulating Vimentin: A Systems-Level Therapeutic Strategy for Sepsis and Complex Diseases.Life (Basel, Switzerland) · 2026Article
- Withaferin A inhibits EBV-driven lymphomagenesis through multiple mechanisms, including EBNA1 degradation.Blood · 2026Article
- Targeting Cancer Stem Cells with Phytochemicals: Molecular Mechanisms and Therapeutic Potential.Biomedicines · 2026Review
- Advances in Chemotherapy in Pediatrics Acute Lymphocytic Leukemia (Pall): Actions, Associated Risks and Emerging Therapies.Current pharmaceutical design · 2026Review
- A review of protective effects ofFrontiers in pharmacology · 2026Review
- Overview of Ayurveda and Ashwagandha: Bioactive Phytochemicals and Potential Applications to Gliomas.Molecules (Basel, Switzerland) · 2025Review
- Withaferin A Rescues Brain Network Dysfunction and Cognitive Deficits in a Mouse Model of Alzheimer's Disease.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Current mechanistic insights into Withaferin A: a promising potential adjuvant anticancer agent from Withania somnifera.Naunyn-Schmiedeberg's archives of pharmacology · 2025Review
- Unraveling the role of withanolides as key modulators in breast cancer mitigation.Molecular biology reports · 2025Review
- An open-label, single dose, safety and pharmacokinetic study ofDrug metabolism and personalized therapy · 2025Article
- Evaluation of reversible cytochrome P450 inhibition by Withania somnifera leaf and root extracts.Drug metabolism and disposition: the biological fate of chemicals · 2025Article
- Article
- Ashwagandha (Journal of dietary supplements · 2025Article
- Randomized, Double-Blind, Crossover Study Comparing the Bioavailability of 4 Ashwagandha (Current therapeutic research, clinical and experimental · 2025Article
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWithaferin-A (WA), an active principle obtained from a traditional Indian herb known as Ashwagandha or the Indian ginseng, has been shown to prevent and cure urethane-induced lung tumors in mice, and also inhibit the growth of transplanted sarcoma in mice.
objectivesIn this study, we evaluated the safety and pharmacokinetics of WA in patients with advanced stage high-grade osteosarcoma.
methodsA phase I dose escalation study was planned using the classical 3 + 3 design (C33D). Dose escalation cohorts comprised of 72, 108, 144 and 216 mg of WA administered in two to four divided doses per day. Three patients were enrolled in each cohort and the last patient was observed for at least 30 days for any dose-limiting toxicity before progressing to a higher cohort. Pharmacokinetic studies were performed using high performance liquid chromatography (HPLC) technique with sensitivity up to 50 ng/ml. Safety evaluation including clinical examination, detailed history of adverse events, Liver Function Tests , Renal Function Tests and complete blood counts were performed at each visit. WA was administered daily till progression. Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 was used for grading adverse events.
resultsThe formulation used was generally well tolerated. Eleven adverse events of grade 1 or grade 2 severity were observed. No grade 3 or grade 4 adverse events were observed. Elevation of liver enzymes (5/11) and skin rash (2/11) was the most common adverse events. Other adverse effects include fatigue, fever, edema, and diarrhea (one each). None of the patients had detectable levels of WA in circulation.
conclusionThe formulation was well tolerated. However, WA appears to have low oral bioavailability. Further studies with improved formulations are warranted.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.