EFFICACY OF INDIVIDUALIZED HOMOEOPATHIC MEDICINES IN THE TREATMENT OF FIBROMYALGIA SYNDROME AMONG WOMEN OF REPRODUCTIVE AGE GROUP: A DOUBLE BLIND RANDOMIZED PLACEBO CONTROLLED TRIAL
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- To evaluate the effect of individualized homoeopathic medicines of women of reproductive age group having fibromyalgia syndrome through fibromyalgia impact questionnaire (FIQ)
研究概览
简要总结
This study is double blind randomized placebo controlled trial in patients of Fibromyalgia syndrome among women of reproductive age group. The primary outcome measure is to evaluate the effect of individualized homoeopathic medicines of women of reproductive age group having fibromyalgia syndrome through fibromyalgia impact questionnaire (FIQ) at baseline and 3 months interval with comparing placebo. The secondary outcome measure is to evaluate causal attribution of Clinical outcome at end of treatment of fibromyalgia syndrome by using Modified Naranjo Criteria (MONARCH).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 15.00 Year(s) 至 49.00 Year(s)（—）
- 性别
- Female
入选标准
- •Women of reproductive age provided who have set in menarche, does not set in menopause.
- •Age between 15 to 49 years.
- •Patients suffering from Fibromyalgia syndrome according to Fibromyalgia criteria 2016 revision of American College of Rheumatology.
- •Patients who will provide written informed consent.
排除标准
- •Patient suffering from any terminal illness, life threatening condition or taking medication for any major systemic diseases.
- •Chronic alcoholism and substance abuse.
- •Pregnant and lactating mothers.
- •Psychologically unstable patients or insane individuals.
结局指标
主要结局
To evaluate the effect of individualized homoeopathic medicines of women of reproductive age group having fibromyalgia syndrome through fibromyalgia impact questionnaire (FIQ)
时间窗: Assessment will be done at baseline and after three months.
次要结局
- To evaluate causal attribution of Clinical outcome at end of treatment of Fibromyalgia syndrome by using Modified Naranjo Criteria (MONARCH)(at end of treatment (three months))
研究者
RAHITOSH GHOSH
MAHESH BHATTACHARYYA HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL