Homeopathic treatment of painful menses

Phase 3

Completed

• Conditions: Primary dysmenorrhea,

• Registration Number: CTRI/2018/10/016013
• Lead Sponsor: Mahesh Bhattacharyya Homoeopathic Medical College and Hospital

Brief Summary

Primarydysmenorrhoea refers to one that is not associated with any identifiable pelvicpathology. The pathogenesis of pain is attributed to a biochemical derangement.It affects more than 50% post pubescent women in the age group of 18–25 yearswith ovulatory cycles. Homeopathy treatment for the said condition is claimed to be beneficial,still systematic research evidences remain compromised. This study has been undertaken to examine the efficacy of individualised homeopathic medicines against placebo in treatment of primary dysmenorrhea. In this prospective, double blind, randomised, placebo controlled,parallel arm trial at Mahesh Bhattacharyya Homoeopathic Medical College andHospital, 128 patients suffering from primary dysmenorrhea will be randomised in 1:1ratio into either individualised homeopathic treatment or identicalplacebo. A 0-10 Numeric Rating Scale (NRS) measuring intensity of pain of dysmenorrhea and Verbal Multidimensional scoring system (VMSS) assessing the severity of dysmenorrhea symptoms and itsassociated symptoms will be used as the primary and secondary outcome measuresrespectively, measured at baseline, and every month up to 3 months. At the endof 3 months, comparative analysis will be carried out to detect groupdifferences, if any. Results will be published in scientific journals.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-11
• Last Update Posted: 2020-09-22

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 128

Inclusion Criteria

a) Female cases suffering from primary dysmenorrhoea, pain score of 4 to 9 on Numeric Rating Scale in the last three cycles b) Age between 13 and 45 yrs c) Capability and willingness to give informed consent and to comply with the study procedure.

Exclusion Criteria

• a) Cases suffering from severe dysmenorrhea, are too sick for consultation b) Cases suffering with secondary dysmenorrhea c) Patients using oral contraceptive pills, hormone replacement therapy or corticosteroids or having a history of their use in previous 3 months d) Unevaluated gynaecological abnormalities; e.g. unexplained vaginal bleeding, cervical dysplasia, pelvic inflammatory diseases (PID) within one month, patients with suspicious adenomyosis, gross developmental defect or congenital abnormalities of the uterus etc.
• or patients having history of breast or reproductive organ cancer or patients underwent hysterectomy and/or bilateral oophorectomy or change in hormone status (introduction of an oestrogen and/or progestogen, amenorrhoea, pregnancy etc.) e) Diagnosed cases of uncontrolled systemic diseases, unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life or any organ failure f) Undergoing homoeopathic treatment for chronic disease within last 6 months g) Self-reported immune-compromised state h) Patient with psychiatric disorders i) Patients unable to read patient information sheet j) Patients unwilling to take part or not giving consent to join the study k) Substance abuse and/or dependence l) Cases requiring immediate surgical intervention.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
0-10 Numeric Rating Scale (NRS) measuring intensity of pain of dysmenorrhea	At baseline, every month up to 3 months

Secondary Outcome Measures

Name	Time	Method
Verbal Multidimensional scoring system assessing the severity of dysmenorrhea symptoms and its associated symptoms	At baseline, every month up to 3 months

Trial Locations

Locations (1)

OPD room no 5, Dept of Obstetrics and Gynaecology, M B H Medical College & Hospital; 🇮🇳 Haora, WEST BENGAL, India

OPD room no 5, Dept of Obstetrics and Gynaecology, M B H Medical College & Hospital

🇮🇳Haora, WEST BENGAL, India

Rai Khushboo Ravindra

Principal investigator

7985399380

ksb26592@gmail.com