Effectiveness of individualized homoeopathic medicines in treatment and improvement of Health-Related Quality of Life of patients suffering from Tension-type headache using Kents repertory: A single group, pre-post interventional study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pain and disability assessment with Numeric Pain Rating Scale and Headache Disability Index Scale, respectively.
研究概览
简要总结
Tension-type headaches (TTH) are recurrent episodes of headache lasting for minutes to weeks. It is a variant of primary headache disorders. It has high prevalence and significant morbidity and it also lacks effective treatment modalities. There are very few clinical studies made in TTH in terms of treatment and headache related disability and its affect in quality of life, and there are insufficient evidences to support use of homoeopathy in management of TTH owing to deficient quality and quantity of literature and use of validated scales. So, this study is undertaken to justify following question and hypothesis:
Research question: Are individualized homoeopathic medicine effective in treating and improving the health-related quality of life of patients with TTH?
Hypothesis:
Null hypothesis: Homoeopathic medicines are not effective in treating and improving the health-related quality of life of patients with TTH
Alternative hypothesis: Homoeopathic medicines are effective in treating and improving the health-related quality of life of patients with TTH
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •a) Self reporting patients with headache lasting for 30 minutes to 7 days (or more) for minimum of 6 months, fulfilling following criteria: 1) Two out of following i) Bilateral headache ii) Pressing/ tightening in quality iii) Mild to moderate intensity iv) Not aggravated by routine physical activity 2) Both of the associated symptoms i) No Nausea and vomiting (anorexia may occur) ii) No more than one of photophobia or phonophobia b) Patient who can give consent c) Patient who are not under homoeopathic treatment for last 2 weeks.
排除标准
- •a) Abrupt onset of headache or change in their normal pattern or type of headache b) Post traumatic headache and intractable headache c) Patient on regular NSAID within 2 months of reporting d) Any known systemic disease or uncontrolled diseases or infections affecting quality of life e) Pregnant and lactating mothers f) Substance abuse and/or dependence g) Self reported cases of immune compromised state.
结局指标
主要结局
Pain and disability assessment with Numeric Pain Rating Scale and Headache Disability Index Scale, respectively.
时间窗: Baseline and at each follow up at an interval of 4 weeks for 3 months
次要结局
- Assessment of quality of life using WHOQOL-BREF(Baseline and at each follow up at an interval of 4 weeks for 3 months)