A double-blind, randomized, placebo-controlled trial to evaluate the efficacy of individualized homeopathic medicines using polarity analysis in the treatment of tension type headache in adults
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Headache Impact Test-6 (HIT-6)
研究概览
简要总结
Tension type headache (TTH) (ICD11- 8A81.Z) ranks among the most prevalent causes of headaches globally. The analysis of 357 publications indicates that the estimated global prevalence of tension type headache (TTH) is 26.0% (ranging from 22.7% to 29.5%) with a prevalence of 23.4% among men and 27.1% among women. Homoeopathy is a frequently used therapy to treat tension type headache; however, the research evidence is limited. This double-blind, randomized, placebo-controlled trial is aimed at evaluating the efficacy of homeopathic medicines in the treatment of tension type headache in 63 adults. The primary outcome measure is HIT-6; the secondary outcome measures are HDI and MYMOP-2 questionnaires, all measured at baseline and every month up to 3 months. Comparative analysis will be carried out to detect the group differences. Results will be published in scientific journals.
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
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed TTH (ICD11- 8A81.Z) as per the third edition of the International Classification of Headache Disorders (ICHD-3).
- •Age 18-65 years.
- •Participants of either sex or transgender.
- •At least 5 polar symptoms and 10 indicated remedies under a rubric.
排除标准
- •Not willing to give written informed consent of participation.
- •Uncontrolled hypertension, diabetes or cancer or any other systemic illness, or any vital organ failure.
- •Vulnerable population– unconscious, non-ambulatory, too sick for consultation, terminally ill or critically ill, mentally incompetent people.
- •Pregnancy, puerperal women and lactating mother.
- •Tobacco chewing and/or smoking, alcoholism and/or any form(s) of substance abuse and/or dependence (TAPS tool).
- •Self-reported immune-compromised state, AIDS, hepatitis etc.
- •Simultaneous participation in any other clinical trial.
- •Undergoing homoeopathic treatment for any chronic disease within the last 3 months.
结局指标
主要结局
Headache Impact Test-6 (HIT-6)
时间窗: Baseline and every month upto 3 months
次要结局
- Headache Disability Inventory/Index (HDI)(Baseline and every month upto 3 months)
- Measure Yourself Medical Outcome Profile version 2(Baseline and every month upto 3 months)
研究者
Tanay Sarkar
D N De Homoeopathic Medical College and Hospital