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Study to Evaluate the Safety and Effectiveness of Withaferin A as a Treatment to Prevent GvHD in Transplant Patients

RecruitingPhase 1, Phase 2Ages 18 Years - anyAllTata Memorial Centre
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In plain words

What the trial is, and whether it could suit you

What is acute Graft versus host disease (aGvHD)? GvHD is a complication that can occur after an allogeneic stem cell transplant resulting in damage to some organs. The death rate of GvHD patients is 15-40%. In GvHD, the donated peripheral blood stem cells or bone marrow view the recipient's body as foreign, and the donated cells/bone marrow harm the body. aGvHD usually develops in skin, liver or gastrointestinal tract, and symptoms might appear within few weeks after transplant. Symptoms of acute GvHD are observed as skin rash or reddened areas on the skin, yellow discoloration of the skin and/or eyes, and abnormal blood test results, nausea, vomiting, diarrhea, or abdominal cramping. What is the current prevention used for GvHD? To prevent development of GvHD many standard drugs like cyclosporine (CSA), tacrolimus (TAC), methotrexate (MTX), mycophenolate mofetil (MMF), rapamycin and cy

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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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What it tests

  • SWA (standardized root extract of Withania somnifera)
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Where

2 sites
Advanced Centre for Treatment, Research and Education in Cancer
Navi Mumbai, India
Advanced Centre for Treatment, Research and Education in Cancer
Navi Mumbai, India
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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