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Homoeopathic treatment of tumors in uterus

Phase 2
Conditions
Health Condition 1: D25- Leiomyoma of uterusHealth Condition 2: null- Uterine fibroids
Registration Number
CTRI/2018/03/012571
Lead Sponsor
ational Institute of Homoeopathy Ministry of AYUSH Govt of India
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
0
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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
terine Fibroid Symptoms Quality of Life (UFS-QOL) questionnaire (translated Bengali version)Timepoint: Baseline, after 3 months and after 6 months
Secondary Outcome Measures
NameTimeMethod
umber and/or size of uterine fibroid(s), as detected on pelvic ultrasound or transvaginal sonographyTimepoint: Baseline, after 3 months and after 6 months
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