Health Condition 1: D25- Leiomyoma of uterus Health Condition 2: null- Uterine fibroids
Conditions
Interventions
Intervention1: Aurum Muriaticum Natronatum in centesimal or 50 millesimal potencies: In centesimal scale, each dose consist of a single drop of Aurum Muriaticum natronatum (preserved in 90% v/v ethano
dosage and repetition depending upon the individual requirement of the cases. In 50 millesimal scale, a single medicated cane sugar globule of poppy seed size (no. 10) will be dissolved in 90 ml disti
16 doses to be marked on the vial
Sponsors
National Institute of Homoeopathy Ministry of AYUSH Govt of India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Premenopausal women 2. Age 18-45 years 3. Uterine fibroids confirmed by pelvic and/or transvaginal ultrasonography 4. Presence of any of the symptoms such as abnormal uterine bleeding (profuse menstruation or intercyclic menstruation), pelvic heaviness, pain during menstruation, pain during intercourse, and pressure symptoms such as urinary frequency, constipation etc. 5. Patients taking oral contraceptive pills (OCPs) will be advised to stop pills till it exhaust for the ongoing cycle and willing to continue any other alternative methods of contraception followed by re-assessment of symptoms in the next cycle enrolment 6. Patients under hormonal replacement therapy (HRT) to be included after a washout period of 3 months 7. Patients with known but controlled systemic diseases with medication 8. Ability to read Bengali 9. Patients giving written consent to participate in the study
Exclusion criteria
Exclusion criteria: 1. Asymptomatic fibroids 2. Patients with calcified fibroid, coagulation disorders, extra uterine fibroid, uro-genital polyp, any fibroid causing hydronephrosis , fibroid with solid ovarian mass 3. 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. 4. Patients with hemoglobin less than 7 gm/dl (severe anaemia) 5. Genito-urinary tract malignancy (suspected/diagnosed) 6. Patients desiring immediate surgical management for uterine fibroid 7. Previous history of myomectomy, myolysis, uterine artery embolisation, etc., for uterine fibroids 8. Patients desiring for childbearing within next year 9. Patients insisting to use OCPs 10. Patients with psychiatric diseases 11. Pregnancy and lactation 12. Cases suffering from uncontrolled systemic illness or life-threatening infections or any vital organ failure 13. Cases already undergoing homoeopathic treatment for any chronic purpose 14. Substance abuse and/or dependence 15. Self-reported immune-compromised state
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Uterine Fibroid Symptoms Quality of Life (UFS-QOL) questionnaire (translated Bengali version)Timepoint: Baseline, after 3 months and after 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Number and/or size of uterine fibroid(s), as detected on pelvic ultrasound or transvaginal sonographyTimepoint: Baseline, after 3 months and after 6 months | — |
Countries
India
Contacts
Public ContactAbhijit Chattopadhyay
National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India
Outcome results
None listed