Validation of the translated Bengali version of Uterine Fibroid Symptom Quality of Life questionnaire (UFS-QOL) & open observational trial to evaluate effectiveness of individualized homoeopathic treatment of symptomatic uterine fibroids

ational Institute of Homoeopathy Ministry of AYUSH Govt of India0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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, 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

•1. Asymptomatic fibroids
•2. Patients with calcified fibroid, coagulation disorders, extrauterine fibroid, polyp, cervical fibroid, 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 etc.
•4. Patients with haemoglobin less than 7 gm/dl (severe anaemia)
•5. Recent rapid growth of fibroid; i.e. doubling in size within last one to six months
•6. Genito-urinary tract malignancy
•7. Patients desiring immediate surgical management for uterine fibroid
•8. Previous history of myomectomy, myolysis, uterine artery embolisation, etc., for uterine fibroids
•9. Patients desiring for childbearing within next year
•10.Patients insisting to use OCPs
•11.Patients with psychiatric diseases
•12.Pregnancy and lactation
•13.Cases suffering from uncontrolled systemic illness or life-threatening infections or any vital organ failure
•14.Cases already undergoing homoeopathic treatment for any chronic purpose
•15.Substance abuse and/or dependence

发起方

ational Institute of Homoeopathy Ministry of AYUSH Govt of India