Anaemia control among adolescent girls through Ayurveda interventions in the five districts under Mission Utkarsh
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 1,505
- 试验地点
- 5
- 主要终点
- The impact of the Ayurveda interventions on the status of Anemia in the sample selected from the population will be assessed through –
研究概览
简要总结
This project includes two components - 1) Distribution of Ayurveda medicine to all the adolescent girls (age 14-18 years) registered in the Poshan scheme of Ministry of Women and Child Development, Government of India, in the Anganwadi Centres of the five districts identified under Mission Utkarsh. Total target number of beneficiaries (population) for distribution of Ayurveda medicines is 94,635 girls. 2) However, the effect of the Ayurveda interventions in prevention on the parameters of anemia will be assessed independently by Indian Institute for Public Health, Delhi in a sample of 1505 participants among the said population in the five districts.
The Ayurveda interventions viz., Krimimudgar Rasa (7 days), Drakshavaleha (90 days) and Punarnavadi Mandur (90 days), with known effectiveness and safety will be given as adjunct to the standard ongoing measures for Anaemia prevention, to the adolescent girls (of age 14 to 18 years), registered in the Poshan Scheme at the Anganwadi centres in the identified districts. Information education and communication will be done regarding appropriate nutrition, the importance of treatment adherence to the conventional regimen of Iron-Folic Acid and, the Ayurveda interventions in this project and, other healthy lifestyle practices will also be given to all the beneficiaries.
This project is a joint venture of Ministry of Ayush and Ministry of Women and Child Development and is implemented by CCRAS. This is a multi-centre project which will be executed by five Ayush institutes and the outcome will be assessed in all the five districts by Investigators of IIPH-D.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 14.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- Female
入选标准
- •Girls between 14-18 years of age and willing to take the Ayurveda interventions for 3 months along with the ongoing conventional anemia prevention measures.
排除标准
- •Girls who are married/pregnant 2) Known cases of any Hemoglobinopathies, bleeding disorders, serious systemic illnesses, Diabetes mellitus, malignancies, and having family history of hemoglobinopathies and history of blood transfusion in last 6 months.
结局指标
主要结局
The impact of the Ayurveda interventions on the status of Anemia in the sample selected from the population will be assessed through –
时间窗: 12 weeks
change in hemoglobin level (venous), ferretin level, score of fatigue assessment scale (FACIT) and score of appetite assessment scale (SNAQ), before and after the intervention for three months
时间窗: 12 weeks
(This will be independently assessed by the Indian Institute of Public Health, Delhi and the proposal is approved by their IEC)
时间窗: 12 weeks
次要结局
- 1) Change in hemoglobin (capillary) assessed through strip based digital hemoglobinometer, incidence of fatigue & status of appetite of the population taking Ayurveda interventions(2) Proportion of the beneficiaries showing thinness assessed by body mass index (BMI) for age (as per the 2007 WHO Growth Reference), after the intervention period)
研究者
Dr Sarada Ota
Central Council for Research in Ayurvedic Sciences