Individualized Homoeopathic Medicines in Treatment of Premenstrual Syndrome: Double- blind, Randomized, Placebo-controlled, Pilot Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Shortened Premenstrual Assessment Form (SPAF)
研究概览
简要总结
Premenstrual syndrome (PMS) is one of the commonest problems in females of reproductive age group. This pilot trial aimed at testing the feasibility of future definitive trial and evaluated whether individualized homoeopathic medicines (IH) have a significant effect beyond placebo in PMS symptoms. A double-blind, randomized (1:1), placebo-controlled, parallel arms, a pilot trial will be conducted at National Institute of Homoeopathy, Kolkata, West Bengal, India. Patients received either IH (n=30) or identical-looking placebo (n=30) during the trial. Outcomes will be measured every month up to 3 months. Group differences will be estimated by intention-to-treat analysis. The trial results will enable us to understand the effect of homoeopathic medicines in PMS, the feasibility of conducting such trials in future and direction to the future studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Permuted block randomization, variable
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Cases suffering from PMS for more than 3 months, diagnosed as per ICD-10 criteria
- •Patients taking oral contraceptive pills (OCPs) will be advised to stop pills till it exhaust for the ongoing cycle, followed by reassessment of PMS symptoms in the next cycle enrolment
- •Patients under hormonal replacement therapy (HRT) to be included after a washout period of 3 months
- •Literate patients; ability to read Bengali and/or English
- •Patients giving written consent to participate.
排除标准
- •PMDD states
- •Patients underwent a hysterectomy and/or bilateral oophorectomy
- •Primary or secondary amenorrhoea
- •Change in hormone status (introduction of oestrogen and/or progestogen, amenorrhoea, pregnancy etc.)
- •Patients having a history of breast or reproductive organ cancer
- •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.
- •Patients with psychiatric diseases
- •Cases suffering from uncontrolled systemic illness, life-threatening infections, or any vital organ failure
- •Patients insisting to use OCPs and HRT
- •Cases already undergoing homoeopathic treatment for any chronic purpose
- •Substance abuse and/or dependence 12.Self-reported immune-compromised state.
结局指标
主要结局
Shortened Premenstrual Assessment Form (SPAF)
时间窗: Baseline, 1 month, 2 month, 3 month
次要结局
- participant-rated Premenstrual Tension(Syndrome Visual Analogue Scale (PMTS-VAS))
- Premenstrual Tension Syndrome(Observer Rating Scale – Revised (PMTS-OR))