A RANDOMIZED CONTROLLED CLINICAL AND IN SILICO ANALYSIS OF THE ADD-ON EFFECT OF DRAKSHA DADIMADI AVALEHA AND GANDHAKADI YOGA TABLETS ON THE FREQUENCY OF BLOOD TRANSFUSIONS IN THALASSEMIA MAJOR
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
This randomized controlled clinical trial aims to evaluate the add-on effect of Draksha-Dadimadi-Gandhakadi Yoga tablets in reducing the frequency of blood transfusions among patients with Thalassemia Major. Thalassemia Major is a chronic hemoglobinopathy requiring lifelong regular transfusions, which lead to iron overload, repeated hospitalization, and reduced quality of life.
The study will enroll participants diagnosed with transfusion-dependent Thalassemia Major who meet predefined inclusion criteria. Participants will be randomly allocated into two groups: one receiving standard conventional management alone (control group) and the other receiving standard management along with Draksha-Dadimadi-Gandhakadi Yoga tablets as an add-on intervention (intervention group).
The primary outcome is the change in the frequency of blood transfusions during the study period. Secondary outcomes include changes in hemoglobin levels, serum ferritin levels, quality-of-life scores, and safety parameters. The intervention duration and follow-up are designed to assess both efficacy and safety.
This study will provide evidence on whether the Ayurvedic formulation can serve as a safe and effective adjunct therapy to reduce transfusion requirements and improve clinical outcomes in Thalassemia Major.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 3.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- All
入选标准
- •Hb electrophoresis diagnosed cases of Thalassemia major.
- •Age groups of 3 to 16 years of either sex.
- •Patients on a regular blood transfusion regimen to maintain a pre-transfusion hemoglobin level between 9 and 10 g per dL.
- •Patients having history of receiving at least 8 or more blood transfusions per year.
- •Parents or guardian willing to give consent to participate in the study.
排除标准
- •Cases having HIV, HBV infection, Hepatic failure, DM, TB, malarial infection, active liver disease etc.
- •Other haemoglobinopathies like sickle cell anemia, hereditary spherocytosis etc.
- •Patients having cardiac and kidney complications.
- •Patients undergone Splenectomy and allogeneic bone marrow transplantation.
- •Known allergy to any content of Draksha dadimadi Avaleha and Gandhakadi Yoga tablets.
研究者
Bhavana Nandakumar
All India Institute of Ayurveda