Homoeopathy in the treatment of dysmenorrhea in adolescents

Phase 3

Recruiting

Conditions: Primary dysmenorrhea,

Registration Number: CTRI/2023/11/060229

Lead Sponsor: Central Council for Research in Homoeopathy

Brief Summary: Dysmenorrhea is one of the most common gynaecological problems and is characterized by acute pelvic pain during menstruation. Primary dysmenorrhea is the presence of painful menstruation in the absence of pelvic diseases (e.g., endometriosis and pelvic inflammatory disease) or pelvic leiomyoma. Primary dysmenorrhea is the most common form of chronic pelvic pain that can last for at least 6 months, can be severe enough to disrupt oneâ€™s daily life activities, and ultimately lead to medical or surgical treatment. The reported prevalence of dysmenorrhea has ranged from 15.8% to 89.5%, with higher rates reported in adolescent populations. It is the leading women hood problem that affects 90% of adolescent girls and more than 50% menstruating women. Prior studies have shown the impact of dysmenorrhea on quality of life as dysmenorrhea often leads to women not attending school or office. The rate of absence days from school was reported to vary between 14% and 51% among women with dysmenorrhea. The conventional treatment for primary dysmenorrhea is Nonsteroidal anti-inflammatory medications (NSAIDs) and oral contraceptives, but it has lot of side effects. As a result, patients seek complementary and alternative therapies, such as Homoeopathy as a treatment option for Primary dysmenorrhea and in Homoeopathic literature, myriads of drugs have been mentioned for Primary dysmenorrhea. This research study is planned to be carried out to obtain scientific evidence of the effectiveness of homeopathy in in reducing the pain days in Primary Dysmenorrhea in adolescents with an added benefit of knowing the efficacy of homoeopathy in reducing the use of analgesics for dysmenorrhea as well as improving the sick days or days of absenteeism in a student life.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Female

Target Recruitment: 120

Inclusion Criteria

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.

Exclusion Criteria

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 dayâ€™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
Number of pain days in Homoeopathic group as compared to placebo group over 6 months.	At baseline and then every month over 6 months

Secondary Outcome Measures

Name	Time	Method
To evaluate the reduction in consumption of analgesics over 6 months.	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.	At baseline, 3rd and 6th month.
To evaluate the change in intensity of pain of dysmenorrhea on numeric rating scale over 6 months.	At baseline and then every month over 6 months
To evaluate the changes in working ability, location, intensity, days of pain, dysmenorrhea (WaLIDD) score over 6 months.	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.	At baseline and then every month over 6 months

Trial Locations

Locations (3): Central Research Institute (Homoeopathy)
🇮🇳
Lucknow, UTTAR PRADESH, India
Dr D P Rastogi, Central Research Institute (Homoeopathy)
🇮🇳
Nagar, UTTAR PRADESH, India
Regional Research Institute (Homoeopathy)
🇮🇳
Hyderabad, TELANGANA, India
Central Research Institute (Homoeopathy)
🇮🇳Lucknow, UTTAR PRADESH, India
Dr Lipipushpa Debata
Principal investigator
8929031218
drlipi08@gmail.com