Scope of Homoeopathy in menstrual disturbances of adolescent girls
- Conditions
- Polycystic ovarian syndrome, (2) ICD-10 Condition: E289||Ovarian dysfunction, unspecified, (3) ICD-10 Condition: E288||Other ovarian dysfunction,
- Registration Number
- CTRI/2024/06/068833
- Lead Sponsor
- CENTRAL COUNCIL FOR RESEARCH IN HOMOEOPATHY
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- Female
- Target Recruitment
- 240
- 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.
- Female below the age of 12 years and above the age of 18 years.
- Females with abnormal findings on levels of Prolactin, TSH, T3, T4.
- 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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method • Clinical Assessment using MYMOP2, ORIDL at every month up to 12 months • 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 • Every month, upto 12 months. | • Baseline, 3 months, 6 months, 9 months and 12 months.
- Secondary Outcome Measures
Name Time Method •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.
Trial Locations
- Locations (4)
Dr. Anjali Chatterjee Regional Research Institute (H), Kolkata.
🇮🇳Kolkata, WEST BENGAL, India
Dr. D.P. Rastogi Central Research Institute (H)
🇮🇳Ghaziabad, UTTAR PRADESH, India
Drug Proving Unit, unit of CCRH
🇮🇳Khordha, ORISSA, India
Regional Research Institute (H)
🇮🇳Mumbai, MAHARASHTRA, India
Dr. Anjali Chatterjee Regional Research Institute (H), Kolkata.🇮🇳Kolkata, WEST BENGAL, IndiaDr Suraia ParveenPrincipal investigator92312758284drsuraia@gmail.com