Homeopathic medicines in heavy menstrual bleeding due to tumors of uterus

Phase 2

Recruiting

Conditions: Leiomyoma of uterus, unspecified,

Registration Number: CTRI/2019/11/021998

Lead Sponsor: National Institute of Homoeopathy

Brief Summary: It has been estimated that at least 20 percent of women at the age of 30 have got fibroid in their wombs. In conventional therapy, drugs are used as a temporary palliation or may be used in rare cases, as an alternative to surgery. Though homeopathy has promising potentials in treating Heavy Menstrual Bleeding, it has remained mostly anecdotal rather than being evidence-based. Placebo-controlled randomized controlled trial has not been attempted yet in treatment of heavy menstrual bleeding due to uterine fibroids. This study is aimed to assess the efficacy of individualized homeopathic medicines in comparison with placebo in the above said condition. A double blind, randomized, placebo-controlled, two parallel arms clinical trial will be conducted on 68 patients at National Institute of Homoeopathy (NIH). Patients will be randomized to receive either individualized homeopathic medicines in centesimal potencies, or identical looking placebo. Irrespective of groups, all the randomized patients will be advised for iron rich diet. Duration of therapy will be 3 months. Highamâ€™s Pictorial Blood Loss Assessment Chart (PBAC) scoring will be the primary outcome - measured at baseline, and every month, up to 3 months. Uterine fibroid size and number and Uterine Fibroid Symptom And Health - Related Quality of Life (UFS-QOL) questionnaire will be used as secondary outcomes - measured at baseline and after 3 months. Comparative analysis will be carried out to detect group differences. Results will be published in scientific journals.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Female

Target Recruitment: 68

Inclusion Criteria

Patients suffering from heavy menstrual bleeding due to uterine fibroid (PBAC score 100 points or above indicate heavy menstrual bleeding) 2.
Age: 18-45 years 3.
Uterine fibroid detected on Trans-abdominal Sonography 4.
Patients taking Oral Contraceptive Pills will be considered for the study after giving a wash-out period of 1 month 5.
Patients giving written consent to participate in the study.
Literate patients, who can read and write in Bengali.

Exclusion Criteria

Patients who are too sick for consultation.
Unwilling to take part and not giving consent to join the study.
Unable to read patient information sheet.
Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life- threatening illness affecting quality of life or any organ failure.
Patients suffering from uro-genital polyp, uterine fibroid causing hydronephrosis, fibroid with solid ovarian mass, calcified fibroid.
Patients desiring immediate surgical management for uterine fibroid.
Pregnancy and lactation.
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
Highams Pictorial Blood Loss Assessment Chart (PBAC) scoring	Baseline, every month, up to 3 months

Secondary Outcome Measures

Name	Time	Method
Size and number of the fibroids	Baseline and 3 months
b.Uterine Fibroid Symptom And Health - Related Quality of Life (UFS-QOL) questionnaire	Baseline and 3 months

Trial Locations

Locations (1): National Institute of Homoeopathy
🇮🇳
Kolkata, WEST BENGAL, India
National Institute of Homoeopathy
🇮🇳Kolkata, WEST BENGAL, India
Suman Singh
Principal investigator
7890094491
singhsuman1116@gmail.com