Ancient herb, modern hope: ashwagandha compound tested to prevent deadly transplant complication

NCT ID NCT07724873

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 54 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Advanced Centre for Treatment, Research and Education in Cancer

    RECRUITING

    Navi Mumbai, Maharashtra, 410210, India

  • Advanced Centre for Treatment, Research and Education in Cancer

    RECRUITING

    Navi Mumbai, Maharashtra, 410210, India

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