Homoeopathy in the treatment of dysmenorrhea in adolescents
- Conditions
- Health Condition 1: N944- Primary dysmenorrhea
- Registration Number
- CTRI/2023/11/060229
- Lead Sponsor
- Central Council for Research in Homoeopathy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Patients conformed to the diagnostic criterion of Primary Dysmenorrhoea according to the Primary Dysmenorrhea Consensus Guidelines and if they had experienced primary dysmenorrhoea for two or more months.
2.Age between 13 to 19 years.
3.Menstrual cycle(21 to 35) days.
4.Pain on numeric rating scale (NRS) >4.
5.Signed informed consent of the parent and assent of the children.
1.Secondary dysmenorrhea caused by endometriosis, uterine myoma, endometrial polyps, pelvic inflammatory disease, or other gynecological problems confirmed by a gynecological, abdominal ultrasound examination.
2.Females with irregular/infrequent menstrual cycles (outside of the typical range 21 to 35 day’s cycle)
3.Patients with haemoglobin less than 7gm/dl.
4.Patients complicated with severe diseases (e.g. cerebral, liver, kidney, systemic diseases, mental disorders)
5.Received other alternative therapies such as massage, acupressure, herbal therapy in the previous one month.
6.Those who have been treated with hormone drugs over the last 3 months.
7.poor treatment compliance (e.g. unstable working and living situation, difficult follow-up).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is the mean change from baseline in number of pain days as compared to placebo over 6 months.Timepoint: At baseline and then every month over 6 months
- Secondary Outcome Measures
Name Time Method To evaluate the change in intensity of pain of dysmenorrhea on numeric rating scale over 6 months.Timepoint: At baseline and then every month over 6 months;To evaluate the changes in mean number of reporting absenteeism days from school/work over 6 months.Timepoint: At baseline and then every month over 6 months;To evaluate the changes in scores of Menstrual distress questionnaire (MDQ) at 3rd and 6th month.Timepoint: At baseline, 3rd and 6th month.;To evaluate the changes in working ability, location, intensity, days of pain, dysmenorrhea (WaLIDD) score over 6 months.Timepoint: At baseline and then every month over 6 months;To evaluate the reduction in consumption of analgesics over 6 months.Timepoint: At baseline and then every month over 6 months