Scope of Homoeopathy in menstrual disturbances of adolescent girls – A Multi-centric, Prospective study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 试验地点
- 4
- 主要终点
- • Clinical Assessment using MYMOP2, ORIDL at every month up to 12 months
研究概览
简要总结
This study is multicentric prospective single arm study to observe and analyze the effectiveness of Individualized Homoeopathy Medicines for the treatment of menstrual disorders among the unmarried adolescent girls aged between 12- 18 years. The study will be conducted at four different centers in India, which includes at Noida, Puri, Kolkata and Mumbai for a period of 2 years and 6 months. The primary outcome will be done by using MYMOP2, ORIDL for Clinical Assessment at every month up to 12 months and Adolescent health assessment using WHO-5 index and Warwick-Edinburgh Mental Wellbeing scale at base line, 3 months, 6 months, 9 months and 12 months. The secondary outcome will done by the assessment of serum levels of LH, FSH, Oestradiol, free Testosterone, Dehydroepiandrosterone (DHEA), Prolactin, TSH, T3, T4, Lipid profile, Glucose tolerance test, Ultrasonography of abdomen and pelvis at baseline, 6th month and 12th month.
Homoeopathic medicines have been found useful in managing the signs and symptoms observed in menstrual disorders but meager documentation has been done about the effectiveness of homoeopathy medicines in treating such cases. So this study is proposed to see the effectiveness of homoeopathic intervention in the management of menstrual disorders in adolescence.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 12.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- Female
入选标准
- •Unmarried Females in the age group 12 to 18 years.
- •Females with menstrual abnormalities like amenorrhea, oligomenorrhoea, dysmenorrhoea, dysfunctional uterine bleeding.
- •Females not undergoing conventional treatment or any hormonal therapy.
- •Females who have given the written informed consent.
排除标准
- •Female below the age of 12 years and above the age of 18 years.
- •Females with abnormal findings on levels of Prolactin, TSH, T3, T
- •Females taking conventional treatment or any hormonal therapy.
- •Females taking medication for any other severe illness.
- •Females during pregnancy and lactation.
- •Females with no written informed consent.
结局指标
主要结局
• Clinical Assessment using MYMOP2, ORIDL at every month up to 12 months
时间窗: • Every month, upto 12 months. | • Baseline, 3 months, 6 months, 9 months and 12 months.
• Adolescent health assessment using WHO-5 index and Warwick-Edinburgh Mental Wellbeing scale
时间窗: • Every month, upto 12 months. | • Baseline, 3 months, 6 months, 9 months and 12 months.
次要结局
- •Assessment of serum levels of LH, FSH, Oestradiol, free Testosterone, Dehydroepiandrosterone (DHEA), Prolactin, TSH, T3, T4, Lipid profile, Glucose tolerance test, Ultrasonography of abdomen and pelvis(Baseline, 6th month and 12th month.)