Evidence-based Homeopathy in Treatment of Symptomatic Leiomyoma of Uterus: An Open Observational Pilot Study

Mahesh Bhattacharyya Homeopathic Medical College Hospital0 个研究点目标入组 45 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•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

•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.

发起方

Mahesh Bhattacharyya Homeopathic Medical College Hospital