Effect of Individualized Homoeopathic medicines using the Synthetic Repertory in the management of Fibromyalgia a prospective single arm study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- To assess the changes in pain fatigue levels and sleep quality using Revised Fibromyalgia Impact Questionnaire before and after giving individualized Homoeopathic medicines
研究概览
简要总结
Role of individualized Homoeopathic medicines in 35 participants with fibromyalgia using Synthetic Repertory. Revised Fibromyalgia Impact Questionnaire, Perceived Stress Scale and EQ 5D 5L Questionnaire is used for data analysis. Data will be analyzed by using one way repeated ANOVA test. Assessment of data will be done at baseline at 3rd month and at 6th month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 59.00 Year(s)（—）
- 性别
- All
入选标准
- •Age group 18 to 59 years irrespective of their sex socioeconomic status and occupation Participants diagnosed with fibromyalgia according to the american college of rheumatology 2016 criteria Participants who have willingly joined the study and signed the written informed consent form Participants currently taking medications from other systems of medicine will be enrolled only after completing a two-week washout period provided they are willing to discontinue such medicines The occasional use of mild painkillers example paracetamol will be permitted The number and frequency of painkiller doses will be carefully documented at baseline and monitored throughout the study for comparison before and after treatment.
排除标准
- •Participants diagnosed with other chronic pain syndromes Participants diagnosed with hypothyroidism Participants with severe alcohol dependence Presence of severe psychiatric illness Pregnant or lactating women Participants diagnosed with other immunocompromised conditions and autoimmune diseases Participant on medications that cannot be safely stopped or tapered without the authorized physician supervision or where such supervision is unavailable.
结局指标
主要结局
To assess the changes in pain fatigue levels and sleep quality using Revised Fibromyalgia Impact Questionnaire before and after giving individualized Homoeopathic medicines
时间窗: 16 months study | 6 months enrolment | 6 months follow up | 2 months data analysis | 2 months report writing | Revised fibromyalgia impact questionnaire is used | statistical data analysis done at baseline 3rd month and 6th month
次要结局
- To assess the change in stress levels among participants receiving individualized Homoeopathic treatment using the Perceived Stress Scale(16 months study)
- To evaluate the changes in quality of life in fibromyalgia participants following individualized homoeopathic management, measured by the EQ 5D 5L EuroQol 5 Dimension 5 Level questionnaire.(16 months study)
研究者
Ibtisam Naz
Bakson Homoeopathic Medical College and Hospital