Study to evaluate the efficacy of Ayurvedic Intervention with Yoga and Placebo as a treatment regime for Iron Deficiency Anemia: an open label, three arm, randomised control trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Change in laboratory parameters compared to baseline after 3 months of Ayurvedic intervention.
研究概览
简要总结
This study is a three-arm, open-label, parallel-group and placebo-controlled trial. The trial will randomize 123 participants in the ratio of 1:1:1 of 18 yrs. and above equally to 1st arm: Ayurvedic intervention, 2nd arm: Yogic practices, 3rd arm: Placebo. Participants will receive interventions for 3 months.
The primary outcome includes improvement in laboratory parameters after 3 months of interventions. Secondary outcomes include assessment of treatment satisfaction, patient’s compliance, sleep quality, quality of life, mood states, pain and anxiety levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult male and non-pregnant female population having mild or moderate Iron Deficiency anemia (IDA) caused by different aetiology such as abnormal uterine bleeding and other conditions leading to significant blood loss prior to trial enrolment.
- •Hemoglobin ranges Non pregnant women mild: 110 to 119 g per l, moderate: 80 to 109 g per l.
- •Men, 15 years and above mild: 110 to 129 g per l, moderate: 80 to 109g per l.
- •Transferrin saturation less than 20%
- •S-ferritin less than 30 µg per l.
- •Willingness to participate and sign the informed consent form.
排除标准
- •1.Anemia predominantly caused by factors other than Iron Deficiency Anemia e.g. anemia with untreated vitamin B12 or folate deficiency, sickle cell anemia, thalassemia minor.
- •Iron overload or disturbances in utilization of iron (e.g. haemochromatosis and haemosiderosis).
- •Pregnant or lactating women.
- •Known hypersensitivity to any excipients in the investigational drug products.
- •Erythropoietin treatment within 8 weeks prior to the screening visit.
- •Patients planning surgery within the trial phase or received a blood transfusion a week prior to the screening visit.
- •Any other medical condition that, in the opinion of investigator, make the patient incompetent to participate in the trial or place the patient at potential risk, e.g. any chronic comorbidity.
结局指标
主要结局
Change in laboratory parameters compared to baseline after 3 months of Ayurvedic intervention.
时间窗: Baseline, Day 90
Change in laboratory parameter compared to baseline after 3 months of yogic practices.
时间窗: Baseline, Day 90
次要结局
- Changes in sleep quality, quality of life, anxiety levels, fatigue, mood states and pain.(Treatment satisfaction and adherence.)