The Efficacy of Individualized Homoeopathic medicines in Treatment of Primary Dysmenorrhoea:A Double Blind, Randomized, Placebo- Controlled Trial.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Parameters for outcome assessment is the 0-10 Numeric Rating Scale score (NRS)
研究概览
简要总结
Primary dysmenorrhea comes under synonyms of dysmenorrhea under GA34.3 of ICD-11. Its onset occurs mainly during adolescence, within 6 to 24 months after menarche. Dysmenorrhea pain has a clear and cyclic pattern, which is typically severe during the first day of menses and lasts up to 72 hours. Secondary dysmenorrhea refers to pain in the presence of pelvic disease. In addition to lower abdominal/pelvic pain, dysmenorrhea is usually associated with common symptoms, that can be categorized into two main dimensions: physical and psychological symptoms. The commonly experienced physical symptoms are systemic, gastrointestinal, and elimination-related.
There is quite lack of data available in homoeopathy in treatment of primary dysmenorrhoea. keeping in view this lack of validated clinical trial on hemorrhoid, we aimed to evaluate effects of homoeopathic medicines beyond placebo by conducting this double- blind, placebo controlled trial of individualised homoeopathic medicines against placebo at The Calcutta Homoeopathic Medical College & Hospital on 68 participants with primary dysmenorrhoea.
Parameters for outcome assessment in English, Bengali and Hindi version of the NRS and DSI questionnaire. It is a reliable, valid, and sensitive instruments for measurement of pain and overall well-being patients suffering from Primary Dysmenorrhoea..
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
- 13.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- Female
入选标准
- •Inclusion criteria: a.
- •13-30 years Youth females (adolescents and adult female) b.
- •Having moderate or severe primary dysmenorrhea in the recent cycles c.
- •Normal menstrual cycle for more than 6 months d.
- •Have experienced two or more symptoms associated with primary dysmenorrhoea: (nausea, vomiting, diarrhoea, constipation, fatigue, irritability, breast tenderness).
- •Illiterate people will be interviewed by the investigators maintaining adequate privacy to fill up the scales or questionnaires.
- •Literate participant able to read and write in English, Hindi or Bengali g.
- •Participants providing with written informed consent.
排除标准
- •Being under age of 13yrs and above the age of 30yrs.
- •Suffering from a diagnosed gynaecological illness.
- •Having undergone childbirth.
- •Using oral contraceptive pills or corticosteroids or having a history of their use in previous 6 months.
- •Pregnant or lactating women f.
- •Unstable mental or psychiatric illness or other systemic diseases (e.g., uncontrolled hypertension, diabetes, thyroid diseases etc.) affecting quality of life or any vital organ failure.
- •Any substance abuses h.
- •Self-reported immune – compromised state i.
- •Patients who are too sick for consultation j.
- •Simultaneous participation of any other clinical trials k.
- •Undergoing homoeopathic treatment for any chronic disease within last 6 month.
结局指标
主要结局
Parameters for outcome assessment is the 0-10 Numeric Rating Scale score (NRS)
时间窗: 2 years or till sample size achieved.
次要结局
- Dysmenorrhea Symptom Interference Scale (DSI) questionnaire.(2 years or till sample size achieved.)
研究者
Dr Debashis Biswas
The Calcutta Homoeopathic Medical College and hospital