Double-blind, randomized, placebo-controlled trial of individualized homoeopathic medicines in improving pain of primary dysmenorrhoea in women of reproductive age group
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- 0-10 numeric rating scale measuring intensity of pain
研究概览
简要总结
Primary dysmenorrhoeais defined as pain on the lower abdomen or pelvic region without any pelvicpathology that hamper the day-to-day activity of life. Though the use of homoeopathic medicines is prevalent globally to treat the condition, rigorous research evidence in support of homoeopathy in primary dysmenorrhea has remained compromised. Under such circumstances, we intend to undertake this research project to evaluate the efficacy and safety of homoeopathic medicines in the treatment of primary dysmenorrhea in women of reproductive age group. A double-blind, randomized (2:1), placebo-controlled trial will be conducted on 81 women suffering from primary dysmenorrhea at the outpatient’s department of D. N. De Homoeopathic Medical College and Hospital. Assessment will be done by Pain numerical rating scale (NRS) (primary outcome), DSI (Dysmenorrhoea symptom interference scale), MYMOP-2 questionnaire, and frequency of taking paracetamol and/or NSAIDS as rescue remedies (secondary outcomes), 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
- Permuted block randomization, variable
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female patients age between 12 years to 45 years.
- •Patients suffering from PD, pain score of 4-9 on NRS.
- •(ICD-10 code N94.4)
- •Menstrual pain that hampers the day to activity of life.
- •Patients having menstrual pain which may radiate to back or thigh.
- •Female willing to provide a written informed consent voluntarily; illiterate people will be interviewed by the investigators maintaining adequate privacy to fill up the scales or questionnaires.
排除标准
- •1.Patients having any abnormal pelvic pathology in ultrasonography of lower abdomen.
- •2.Patients undergoing any hormone replacement therapy, using contraceptive pills or history of their use in previous 3months.
- •3.Patients on NSAIDs therapy for dysmenorrhoea in regular basis.
- •4.Diagnosed cases of unstable mental or psychiatric illness or other uncontrolled or life-threatening illness affecting quality of life and vulnerable population like unconscious, too sick for consultation, differently abled etc.
- •5.Patient under tobacco chewing and/or smoking, alcoholism and/or any other from(s) of substance abuse and/or dependence.
- •6.Self-reported immune-compromised state.
- •7.Patients already undergoing homoeopathic or other system treatment with in last six months.
- •8.Simultaneous participation in any other clinical trials.
结局指标
主要结局
0-10 numeric rating scale measuring intensity of pain
时间窗: Day 1 and day 2 of menstruation for 3 consecutive months
次要结局
- Dysmenorrhoea Symptom Interference Scale (DSI)(Every month, up to 3 months)
- Frequency of taking PCM or NSAIDs as rescue remedies(Every month, up to 3 months)
- Measure yourself medical outcome profile 2 (MYMOP-2)(Every month, up to 3 months)