Efficacy of individualized homoeopathic medicines in the treatment of pre-menstrual syndrome in reproductive women: A double-blind, randomized, placebo-controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Pre-menstrual syndrome scale (PMSS)
研究概览
简要总结
Premenstrual syndromes are defined as psychological or physical symptoms that appear during the luteal phase of the menstrual cycle, interfere with the person’s regular day to day functioning, and usually go away soon after the onset of menstruation. Premenstrual syndrome (PMS) affects up to 20% of women in their reproductive years and is a major cause of distress and general impairment in everyday life. According to the recent study, the global pooled prevalence of PMS was 47.8%.Previous research conducted in India revealed that 20% of the general population has PMS, and 8% of those who did have severe symptoms. Homoeopathy is frequently used therapy to treat pre-menstrual syndrome; however, the majority of research has remained unpublished or has been published in non-peer reviewed journals. Further research with a larger sample size and objective measures is needed to confirm and enhance the efficacy of individualized homoeopathic medicines (IHMs).This double-blind, randomized, placebo-controlled trial will be an attempt to explore the effects of IHMs in the treatment of premenstrual syndrome in 72 adults. The primary outcome measure is pre-menstrual syndrome scale (PMSS),the secondary outcomes are PMTS-OR,MYMOP-2 questionnaires, all measured at baseline, and every month, up to 3 months. Comparative analysis will be carried out to detect group differences. Results will be published in scientific journals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- Female
入选标准
- •1.Diagnosed PMS (ICD 10-N94.3.) as per American College of Obstetrics and Gynaecologists (ACOG) criteria: If the patient reports at least one of the affective and somatic symptoms present during the five days before menses in each of the three previous menstrual cycles.
- •2.Age 18-40 years.
- •3.Patients not taking any allopathic treatment or using topical agents for PMS from past 2 weeks will be included in the study.
- •4.Patients under hormonal replacement therapy (HRT) to be included after a washout period of 3 months.
- •5.Patients who can read and/or understand either Hindi or English or Bengali.
排除标准
- •1.Not providing with written informed consent of participation.
- •Unwilling to take part and not giving consent to join the study.
- •2.Premenstrual dysphoric syndrome (PMDD) state.
- •3.Irregular cycle, symptoms exist less than 2 cycles.
- •4.Gynaecological problems, including PCOD, PID, endometriosis, fibroid genital tuberculosis and history of any malignancy etc.
- •5.Diagnosed cases of unstable psychiatric illness or other systemic disease like hypertension, heart diseases, diabetes, renal disesase and thyroid disorder affecting quality of life.
- •6.Planning pregnancy in next 3-4 months.
- •7.Patients under other medications for any chronic disease.
- •8.Simultaneous participation in any other clinical trials 9.Tobacco chewing and/or smoking, alcoholism and/or any form(s) of substance abuse and/or dependence (TAPS tool).
- •11.Undergoing homoeopathic treatment for any chronic disease within last 3 months.
结局指标
主要结局
Pre-menstrual syndrome scale (PMSS)
时间窗: Baseline, and every month, up to 3 month
次要结局
- Measure Yourself Medical Outcome Profile version-2 (MYMOP-2)(Baseline, and every month, up to 3 month)
- Premenstrual Tension Syndrome Observer Rating Scale (PMTS-OR)(Baseline, and every month, up to 3 month)
研究者
Ravina Sonkar
D N De Homoeopathic Medical College and Hospital