Efficacy of Homoeopathy in Menstrual Morbidities in Adolescent School-Going Girls: A Cluster Randomized Placebo Controlled Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,000
- 试验地点
- 5
- 主要终点
- Symptomatic improvement on validated scales like MDQ and aMBQ.
研究概览
简要总结
Menstrual abnormalities such as amenorrhoea, dysmenorrhoea, premenstrual syndrome, and abnormal uterine bleeding are common causes for which women seek medical advice and are a major reason for absenteeism among school going and working-age females. To address these issues, a cluster-randomized, single-blind, placebo-controlled trial is proposed to assess the efficacy of individualized homoeopathic treatment in managing menstrual problems among adolescent school going girls aged 10–19 years.
Participants will receive individualized homoeopathic medicines (administered orally as four pills per dose) or placebo, identical in appearance, along with standardized lifestyle modification advice. The intervention will be continued for a duration of six months. All participants will be provided Information, Education and Communication (IEC) materials to reinforce lifestyle and self-care measures.
Primary outcomes include symptomatic improvement on validated scales. Secondary outcomes cover changes in knowledge, attitude, practices, number of sick days, symptom burden, intensity and duration, absenteeism, and dropouts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 10.00 Year(s) 至 19.00 Year(s)（—）
- 性别
- Female
入选标准
- •Adolescent school-going girls between age group 10-19 years suffering from any menstrual complaint.
- •Only those participants giving assent/informed consent or/and the consent of their parents.
排除标准
- •Girls in age years less than 10 or greater than 19 years.
- •Girls without assent, informed consent or/and consent from their parents.
- •Known cases of bleeding disorders or those with a history of bleeding disorder.
- •Known case of uncontrolled systemic illness.
- •Known case of gynaecological conditions requiring surgical intervention.
- •Known case of psychiatric disorders.
- •Self-reported immunocompromised cases.
结局指标
主要结局
Symptomatic improvement on validated scales like MDQ and aMBQ.
时间窗: Monthly for 6 months
次要结局
- Changes in KAP and Menstrual Practice Questionnaire score.(Baseline and end of 6 months)
- Days of absenteeism due to menstrual problems.(Monthly)
- No. of dropouts from school due to menstrual problems.(Monthly)
- Burden, intensity (NRS) and duration of symptoms(hrs/days).(Monthly)
- No. of sick days due to menstrual complaints.(Monthly)
研究者
Dr Anupriya
Central Council for Research in Homoeopathy