To determine the anti-sickling and antioxidant activity of tapyadi loha through in vitro study and to evaluate the safety, efficacy and tolerability of tapyadi loha in sickle cell anemia through pilot clinical study.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- 5.Requirement of intensive care
研究概览
简要总结
- Sickle Cell Anemia (SCA) is a hereditary blood disorder prevalent in India’s tribal populations, with the country holding the highest number of sickle gene carriers globally. Despite treatment strategies involving blood transfusions, hydroxyurea, and stem cell transplantation, challenges like high mortality rates, affordability, and limited access persist. In 2006, Gujarat implemented a program to address SCA. Hydroxyurea, which reduces sickling of red blood cells, and blood transfusions are common treatments, though stem cell transplants remain cost-prohibitive for many. The study aimed to explore the efficacy of Ayurvedic treatments, particularly Tapyadi Loha, in managing SCA by bridging the gap between Ayurveda and Western medicine. The research hypothesizes that Tapyadi Loha possesses anti-sickling and antioxidant properties, offering an alternative or complement to conventional treatments. Phase 1 involves in vitro testing of its effectiveness, while Phase 2 is a clinical trial to assess safety, efficacy, and quality of life improvements for patients. The study aims to provide a scientifically backed solution for SCA management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Non pregnant, non lactating woman.
- •Diagnosed case of sickle cell anemia
- •Willing to give written informed consent for participation in the trial as well as willing and able to comply with study visit schedule and other protocol requirements.
排除标准
- •K/C/O HIV antibody, HBsAg or HCV antibody
- •Alcohol or any drug dependence within past one year.
- •Participation in any other clinical study or receipt of treatment with any investigational drug or device within 1 month prior Screening
- •Patients having acute phase of crisis and with various complication such as stroke, renal failure, spleen infraction, transfusional iron overload and Recently blood transfused individuals.
结局指标
主要结局
5.Requirement of intensive care
时间窗: 1.Maintenance of Hb levels - 0th Day 30th and 60th Day 90th Day | 2.Frequency-duration- intensity of crises - 0th Day 30th and 60th Day 90th Day | 3.Requirement of in-patient hospitalization - 0th Day 30th and 60th Day 90th Day | 4.Number of days of hospitalization - 0th Day 30th and 60th Day 90th Day | 5.Requirement of intensive care - 0th Day 30th and 60th Day 90th Day | 6.Quality of life- 0th Day 30th and 60th Day 90th Day
1.Maintenance of Hb levels
时间窗: 1.Maintenance of Hb levels - 0th Day 30th and 60th Day 90th Day | 2.Frequency-duration- intensity of crises - 0th Day 30th and 60th Day 90th Day | 3.Requirement of in-patient hospitalization - 0th Day 30th and 60th Day 90th Day | 4.Number of days of hospitalization - 0th Day 30th and 60th Day 90th Day | 5.Requirement of intensive care - 0th Day 30th and 60th Day 90th Day | 6.Quality of life- 0th Day 30th and 60th Day 90th Day
6.Quality of life.
时间窗: 1.Maintenance of Hb levels - 0th Day 30th and 60th Day 90th Day | 2.Frequency-duration- intensity of crises - 0th Day 30th and 60th Day 90th Day | 3.Requirement of in-patient hospitalization - 0th Day 30th and 60th Day 90th Day | 4.Number of days of hospitalization - 0th Day 30th and 60th Day 90th Day | 5.Requirement of intensive care - 0th Day 30th and 60th Day 90th Day | 6.Quality of life- 0th Day 30th and 60th Day 90th Day
2.Frequency-duration- intensity of crises
时间窗: 1.Maintenance of Hb levels - 0th Day 30th and 60th Day 90th Day | 2.Frequency-duration- intensity of crises - 0th Day 30th and 60th Day 90th Day | 3.Requirement of in-patient hospitalization - 0th Day 30th and 60th Day 90th Day | 4.Number of days of hospitalization - 0th Day 30th and 60th Day 90th Day | 5.Requirement of intensive care - 0th Day 30th and 60th Day 90th Day | 6.Quality of life- 0th Day 30th and 60th Day 90th Day
3.Requirement of in-patient hospitalization
时间窗: 1.Maintenance of Hb levels - 0th Day 30th and 60th Day 90th Day | 2.Frequency-duration- intensity of crises - 0th Day 30th and 60th Day 90th Day | 3.Requirement of in-patient hospitalization - 0th Day 30th and 60th Day 90th Day | 4.Number of days of hospitalization - 0th Day 30th and 60th Day 90th Day | 5.Requirement of intensive care - 0th Day 30th and 60th Day 90th Day | 6.Quality of life- 0th Day 30th and 60th Day 90th Day
4.Number of days of hospitalization
时间窗: 1.Maintenance of Hb levels - 0th Day 30th and 60th Day 90th Day | 2.Frequency-duration- intensity of crises - 0th Day 30th and 60th Day 90th Day | 3.Requirement of in-patient hospitalization - 0th Day 30th and 60th Day 90th Day | 4.Number of days of hospitalization - 0th Day 30th and 60th Day 90th Day | 5.Requirement of intensive care - 0th Day 30th and 60th Day 90th Day | 6.Quality of life- 0th Day 30th and 60th Day 90th Day
次要结局
- 1) To determine the safety and tolerability of Tapyadi Loha in Sickle cell anemia on the basis of occurrence/ severity/ requirement of medicine/ causality assessment of adverse event.(1) To determine the safety and tolerability of Tapyadi Loha in Sickle cell anemia on the basis of occurrence/ severity/ requirement of medicine/ causality assessment of adverse event. -0th Day)