Comparing Individualized Homoeopathic Medicine, Biochemic medicines and Nutritional advise in alleviating Micronutrient deficiencies: A pilot randomized placebo controlled trial in school going children.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Improvement in serum levels of the deficient micronutrients (Vitamin B12, D, Iron, Calcium, Zinc, Magnesium and Iodine) across the three treatment groups.
研究概览
简要总结
Study titled "Comparing Individualized Homoeopathic Medicine, Biochemic medicines and Nutritional advise in alleviating Micronutrient deficiencies: A pilot randomized placebo controlled trial in school going children." is Pilot, Single blind, randomized, controlled trial & would be conducted in identified schools through DDPRCRIH Noida for a period of 1 year with a primary objective to identify single and multiple micronutrient deficiencies in school children which will be assessed at baseline, 3 months and 6 months across the three treatment groups. Sample size is 120 participants. There will be 40 participants in each group. Group 1 will receive Individualized homoeopathic medicines in centesimal potency will be prescribed as per the principles of Homoeopathy for 6 months and Nutritional Counselling. Group 2 will receive Biochemic Medicines, twice a day for 6 months and Nutritional Counselling. Group 3 will receive Placebo and Nutritional Counselling. Participants diagnosed with one or more micronutrient deficiencies of all genders in age group of 6-17 years will be included in study. Complete haematological parameters will be assessed at baseline, 3 months and after 6 months of treatment. Clinical assessment including nutritional assessment will be done at baseline and at end of each month upto 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 17.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants of all genders in the age group of 6-17 years.
- •(Class 1- Class 12) Diagnosed with one or more micronutrient deficiencies.
排除标准
- •Children where parents refuse consent and/or child refuses assent.
- •Children currently taking micronutrient supplements or undergoing treatment for micronutrient deficiencies within the last 30 days.
- •Children currently on treatment with corticosteroids, or those who have taken steroids in last 6 weeks.
- •Children with severe malnutrition or those requiring hospitalization for malnutrition.
- •Children with severe micronutrient deficiencies, requiring immediate intervention.
- •Children with psychological or behavioral issues, suffering from any mental illness like Autism, Attention deficit hyperactive disorder.
- •Children with concurrent heart, liver or renal conditions or chronic malignancy selfreported bleeding disorder or haemoglobinopathy, self reported cases of drug reactions, autoimmune diseases, tuberculosis etc.
- •Raised CRP levels greater than 10.0 mg/dl.
结局指标
主要结局
Improvement in serum levels of the deficient micronutrients (Vitamin B12, D, Iron, Calcium, Zinc, Magnesium and Iodine) across the three treatment groups.
时间窗: Baseline, 3 Months, 6 Months
次要结局
- Identification of indicative prevalence range of single micronutrient and multiple micronutrient deficiencies (two or more deficiencies in the same child) in school going children(Baseline)
- Identification of Screening-to-recruitment ratio(Baseline)
- Clinical improvement in deficiency symptoms (e.g., fatigue, cognitive function, growth parameters)(Baseline, 1 Months, 2 Months, 3 Months, 4 Months, 5 Months, 6 Months)
- Identification of symptoms linked to micronutrient deficiencies(Baseline)
研究者
Dr Divya Taneja
Central Council for Research in Homoeopathy