Effectiveness of individualised homoeopathic medicines versus Aurum Muriaticum Natronatum in patients of uterine fibroid: An open-label randomized pragmatic clinical trial
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Uterine Fibroid Symptoms Quality of Life (UFS-QOL) questionnaire (translated Bengali version)
研究概览
简要总结
Uterine fibroids (myomas, fibromyomas or leiomyomas) are themost common, benign, monoclonal tumours of the smooth muscle cells andextracellular matrix proteins collagen and elastin found in the human uterusand are identified as the most common diagnosis associated with a hysterectomy.Uterine fibroids lead to nearly 600,000 hysterectomies performed each year inthe USA and 37,000 myomectomies performed annually, nevertheless,epidemiological data on fibroid prevalence and incidence are limited andreliable population-based research is lacking. Therapeutic options includemedical therapy, surgical interventions like hysterectomy (abdominal, vaginaland laparoscopic) and myomectomy (laparotomy, laparoscopic and hysteroscopic),and newer approaches, such as myolysis, focused ultrasound, transvaginalcryomyolysis and uterine artery embolisation (UAE). All conservative managementoptions allow the possibility for new leiomyomas to form, and pre-existingsmall or undetected leiomyomas may exhibit significant growth, necessitatinganother treatment. Themost frequently consulted alternative therapist for uterine fibroids is a homoeopath[1]; however, there is an acute paucity of published research. In this open, randomized, pragmatic clinicaltrial at National Institute of Homoeopathy, 62 patients will be randomized toeither empirically selected Aurum Muriaticum Natronatum (n=31) or individualizedhomoeopathic medicines (n=31) to examine whether there exist any differenteffect in treatment of uterine fibroids. Uterine Fibroids Symptoms Quality ofLife (UFS-QOL) questionnaire, and pelvic/transvaginal ultrasound measuringnumber and size of fibroids(s) will be assessed at baseline, after 3 months,and after 6 months. Comparative analysis between groups will be carried out to examinegroup differences, if any. Results will be published in scientific journals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Premenopausal women
- •Age 18-45 years
- •Uterine fibroids confirmed by pelvic and/or transvaginal ultrasonography
- •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.
- •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
- •Patients under hormonal replacement therapy (HRT) to be included after a washout period of 3 months
- •Patients with known but controlled systemic diseases with medication
- •Ability to read Bengali
- •Patients giving written consent to participate in the study.
排除标准
- •Asymptomatic fibroids
- •Patients with calcified fibroid, coagulation disorders, extra uterine fibroid, uro-genital polyp, any fibroid causing hydronephrosis , fibroid with solid ovarian mass
- •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.
- •Patients with hemoglobin less than 7 gm/dl (severe anaemia)
- •Genito-urinary tract malignancy (suspected/diagnosed)
- •Patients desiring immediate surgical management for uterine fibroid
- •Previous history of myomectomy, myolysis, uterine artery embolisation, etc., for uterine fibroids
- •Patients desiring for childbearing within next year
- •Patients insisting to use OCPs
- •Patients with psychiatric diseases
- •Pregnancy and lactation
- •Cases suffering from uncontrolled systemic illness or life-threatening infections or any vital organ failure
- •Cases already undergoing homoeopathic treatment for any chronic purpose
- •Substance abuse and/or dependence
- •Self-reported immune-compromised state.
结局指标
主要结局
Uterine Fibroid Symptoms Quality of Life (UFS-QOL) questionnaire (translated Bengali version)
时间窗: Baseline, after 3 months and after 6 months
次要结局
- Number and/or size of uterine fibroid(s), as detected on pelvic ultrasound or transvaginal sonography(Baseline, after 3 months and after 6 months)