Efficacy of Adjuvant Homoeopathic Treatment in Sickle Cell Disease - A Pilot, Single-Blind, Randomized, Placebo-Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Change in frequency, duration and intensity (FDI) of acute Vaso-occlusive pain crisis episodes
研究概览
简要总结
The single blind, randomized, placebo controlled trial will be undertaken at 1 centre providing standard OPD care for Sickle cell disease with an objective to evaluate the efficacy ofadjuvant homoeopathic treatment in management of Sickle Cell Disease by : Assessing change in frequency, intensity and durationof acuteVaso-occlusive pain crisis episode, Assessing number of blood transfusions required, Assessing change in haematological parameters ascompared to baseline, Assessing loss of daily wages due to missed days ofwork and Assessment of quality of life based on Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) at baseline, 6 months and 12months
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed patient of Sickle Cell Disease with reported episodes of acute vaso-occlusive crisis anytime in last 3 months Individuals with vaso occlusive crisis on day of enrollment will be enrolled after the episode of acute crisis is over.
排除标准
- •Individuals having any severe complication of sickle cell disease like acute chest syndrome (ACS), aseptic necrosis of bone, etc.
- •Individuals with any another hemolytic anemia such thalassemia, G6PD, hereditary spherocytosis, hemolytic uremic syndrome, etc.
- •Individuals who have had bone marrow transplantation Individuals with self reported addictions to alcohol, severe end stage comorbidities like stroke, end stage kidney disease.
结局指标
主要结局
Change in frequency, duration and intensity (FDI) of acute Vaso-occlusive pain crisis episodes
时间窗: Patient will be examined on monthly basis. The outcome will be assessed at baseline, 6 month, 12 months.
Frequency will be measured as number of episodes each week
时间窗: Patient will be examined on monthly basis. The outcome will be assessed at baseline, 6 month, 12 months.
Duration will be measured as number of days with pain severe enough to affect daily activities
时间窗: Patient will be examined on monthly basis. The outcome will be assessed at baseline, 6 month, 12 months.
Intensity will be measured on VAS scale as the most severe pain occurring anytime during the acute episode
时间窗: Patient will be examined on monthly basis. The outcome will be assessed at baseline, 6 month, 12 months.
Number of blood transfusions required during the follow up period
时间窗: Patient will be examined on monthly basis. The outcome will be assessed at baseline, 6 month, 12 months.
次要结局
- Change in hematological and biochemical parameters at 6 months and at 12 months as compared to baseline(oHaemoglobin)