Health Condition 1: null- Symptomatic Leiomyoma of Uterus
Conditions
Interventions
Intervention1: Individualized homeopathic
medicines in appropriate doses: Single individualized
homeopathic remedy orally in centesimal or 50 millesimal potencies as appropriate.
Each dose in centesi
Sponsors
Mahesh Bhattacharyya Homeopathic Medical College Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age between 18 years to 40 years 2. Female patients 3. Patients who agree to comply with the current study protocol and giving informed consent 4. Patients presenting with symptomatic uterine fibroids (diagnosed/undiagnosed) such as menorrhagia, metrorrhagia, dysmenorrhea, lower abdominal discomfort or pain, lower back pain and urological symptoms including dysuria and frequency, pressure or pain 5. Intramural fibroid of at least 1 cm in diameter, at least one fibroid on transvaginal ultrasonography, and women who are planning to undergo hysterectomy for treatment of symptomatic fibroids may also participate if they are willing to defer the operation until the study is completed
Exclusion criteria
Exclusion criteria: 1. Severe anemia (hematocrit value less than 30), recent rapid growth of fibroid (i.e. doubling in size within one to six months) 2. Pregnancy, lactation, and likelihood of pregnancy 3. Unevaluated gynecological abnormalities (unexplained vaginal bleeding, cervical dysplasia) 4. Pedunculated fibroid of greater than 5 cm in diameter 5. Patients with pelvic inflammatory disease (PID) developed within one month 6. Patients with suspicious adenomyosis 7. Gross developmental defect or congenital abnormalities of uterus 8. Immune-compromised patients 9. Presence of severe concomitant systemic/infectious/psychiatric disease(s) 10. Clinical findings suggesting failure of vital organs/systems 11. Patients with uncontrolled hypertension, diabetes or other uncontrolled co-morbidities 12. Previous history of myomectomy, myolysis, uterine artery embolization etc. for uterine fibroid 13. Patients already undergoing homeopathic treatment elsewhere 14. Patients with underlying disease affecting quality of life 15. History of alcohol or drug abuse 16. Inability to comply with the protocol 17. If any of the mentioned exclusion criteria developed during the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diameter (cm) of the uterine fibroid, largest one to be considered in multiple fibroidsTimepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Five visual analogue scales of 100 mm measuring pain, heavy bleeding, general well being, quality of sleep and stressTimepoint: 6 months;Uterine fibroid symptoms and health related quality of life questionnaire UFSQOLTimepoint: 6 months | — |
Countries
India
Contacts
Public ContactDr Shubhamoy Ghosh
Mahesh Bhattacharyya Homeopathic Medical College and Hospital Government of West Bengal
Outcome results
None listed