Homeopathic medicines in heavy menstrual bleeding due to tumors of uterus
- Conditions
- Health Condition 1: D259- Leiomyoma of uterus, unspecified
- Registration Number
- CTRI/2019/11/021998
- Lead Sponsor
- ational Institute of Homoeopathy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. 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.
6. Literate patients, who can read and write in Bengali
1. Patients who are too sick for consultation.
2. Unwilling to take part and not giving consent to join the study.
3. Unable to read patient information sheet.
4. Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life- threatening illness affecting quality of life or any organ failure.
5. Patients suffering from uro-genital polyp, uterine fibroid causing hydronephrosis, fibroid with solid ovarian mass, calcified fibroid.
6. Blood hemoglobin level less than 7gm/dl
7. Patients desiring immediate surgical management for uterine fibroid.
8. Pregnancy and lactation.
9. Substance abuse and/or dependence.
10. Self-reported immune-compromised state.
11. 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) scoringTimepoint: Baseline, every month, up to 3 months
- Secondary Outcome Measures
Name Time Method b.Uterine Fibroid Symptom And Health - Related Quality of Life (UFS-QOL) questionnaireTimepoint: Baseline and 3 months;Size and number of the fibroidsTimepoint: Baseline and 3 months