Homeopathic treatment of heavy menstrual bleeding

Phase 2

Recruiting

• Conditions: Excessive, frequent and irregularmenstruation,

• Registration Number: CTRI/2021/12/038645
• Lead Sponsor: D N De Homoeopathic Medical College Hospital

Brief Summary

Heavy menstrual bleeding (HMB)is a common gynecological that adversely affects quality of life and workproductivity. Approximately 10-35%of women report heavy menstrual periodsat some stage during their reproductive years, with 5% consulting a medical practitionerfor investigation of HMB. In research, HMB is defined as a measured menstrualblood loss of more than 80mL per cycle, but studies have repeatedly that atleast 40% of women seeking medical attention for heavy periods lose less thanthis volume. Homeopathy as a therapeutic system may offer significant benefitto patients suffering from HMB; however, the research evidence remainscompromised. In this double-blind, randomized, placebo-controlled pilot trialof individualized homeopathic medicines in treatment of HMB at D N DeHomoeopathic Medical College & Hospital, 60 females will be randomized toreceive either homeopathic medicines or identical-looking placebo for a periodof 3 months. PBAC and MMAS scores will be assessed at baseline and at the endof each menstrual cycle up to 3 cycles as the primary and secondary outcomemeasures respectively. Comparative analysis will be carried out after 3 monthsof intervention. Results will be published in scientific journals.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-12-15
• Study Start: 2021-12-20

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Heavy menstrual bleeding (HMB) as substantiated with a Pictorial blood assessment chart (PBAC) score of 100-185 2.
• Age: 18-45 years 3.
• Patients taking oral contraceptive pills will be considered for the study after giving a wash-out period of 1 month.
• Patients giving written consent to participate in the study.
• Literate patients, who can read and write in Bengali and/or English.

Exclusion Criteria

• Patients suffering from carcinoma of cervix, chronic tubo-ovarian mass, endometrial carcinoma.
• Vulnerable population – unconscious, too sick for consultation, differently abled, terminally or critically ill patients, mentally incompetent.
• Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life- threatening illness affecting quality of life or any organ failure.
• Blood haemoglobin level less than 7g/dl.
• Patient under tobacco chewing and / or smoking, alcoholism and / or any other form(s) of substance abuse and /or dependence.
• Self-reported immune-compromised state.
• Undergoing homeopathic treatment for any chronic disease within last 6 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pictorial blood assessment chart (PBAC) score	At baseline, and after each menstrual cycle up to 3 cycles

Secondary Outcome Measures

Name	Time	Method
Menorrhagia multi-attribute quality-of-life scale (MMAS) score	At baseline, and after each menstrual cycle up to 3 cycles

Trial Locations

Locations (1)

D N De Homoeopathic Medical College and Hospital, Govt. of West Bengal; 🇮🇳 Kolkata, WEST BENGAL, India

D N De Homoeopathic Medical College and Hospital, Govt. of West Bengal

🇮🇳Kolkata, WEST BENGAL, India

Khushbu Pandey

Principal investigator

8777318316

khusi4n@gmail.com