Ancient herb, modern hope: ashwagandha compound tested to prevent deadly transplant complication
NCT ID NCT07724873
First seen Jul 24, 2026 · Last updated Jul 24, 2026
Summary
This trial tests whether a compound from the herb ashwagandha, called withaferin A, can help prevent graft-versus-host disease (GvHD) in people receiving a stem cell transplant for blood cancer. GvHD is a serious complication where donated immune cells attack the recipient's body, affecting up to 60% of patients despite standard prevention. Participants will take withaferin A capsules for 90 days after transplant, alongside standard medications, to see if it safely reduces the risk of acute GvHD.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a standardized root extract of Withania somnifera (ashwagandha) called withaferin A
- What this could lead to
- If it works, this could offer a safe, inexpensive, and easy-to-take pill to prevent a life-threatening complication of stem cell transplants, improving survival and reducing costs.
- What could go wrong
- This is an early-phase trial with only 54 participants, so the results may not apply broadly. Side effects like liver enzyme increases and skin rash are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 54 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. ECOG performance score of 0 or 1 2. Adequate liver function (Total serum bilirubin \< twice upper normal limit or Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 3-fold higher than laboratory upper normal limits) 3. Adequate renal function (creatinine clearance \> 50 ml/min) 4. Adequate cardiac function (LVEF\>40%) 5. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration. 6. Signed, written informed consent Exclusion Criteria: - 1. Known hypersensitivity or contraindications against Withaferin-A. 2. Presence of an active uncontrolled infection defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable to infection. 3. Any medical or psychiatric illness which precludes the participant from giving informed consent 4. Pregnancy, lactation, or inadequate contraception.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Advanced Centre for Treatment, Research and Education in Cancer
RECRUITINGNavi Mumbai, Maharashtra, 410210, India
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Advanced Centre for Treatment, Research and Education in Cancer
RECRUITINGNavi Mumbai, Maharashtra, 410210, India
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can blood tests predict transplant complications?
- Can we predict lung damage from CAR t-cell therapy?
- A new dosing strategy aims to hit the busulfan sweet spot in kids
- Switching stomach drugs after transplant may tame a deadly immune attack
- A guided path back to work after blood cancer: a trial tests the impact
- Could a walk a day keep brain fog away after a stem cell transplant?