The Efficacy of Individualized Homoeopathic Medicines in the Treatment of Chronic Tension Type Headache in Adults: A Double-Blind, Randomized, Placebo-Controlled Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Headache Disability Index, It measures specific symptoms of patients with Headache, consists of 25 Item Beta Version sub grouped into Functional and Emotional Subscale
研究概览
简要总结
CTTH is a disorder evolving from frequent episodic tension-type headaches with daily or very frequent episodes of headache, typically bilateral, pressing or tightening in quality and of mild to moderate intensity, lasting hours to days, or unremitting. The pain does not worsen with routine physical activity, but may be associated with mild nausea, photophobia, or phonophobia. Tension-type headaches are very common, with a lifetime prevalence in the general population, ranging in different studies between 30% and 78%. It has a high socio-economic impact. There is no clinical trial in homoeopathy that shows the effectiveness of the last 5 years. 144 eligible patients will be included in the trial. Following that, baseline outcome data (Headache Disability Index Scale, HDIs questionnaire scores, and EuroQol 5 Dimension 5 Level, EQ-5D-5L questionnaire scores); will be obtained and the patients will be randomized either to verum or IHMs. or control (identical-looking placebo) in 2:1 ratio.
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
- •1.Age between 18 and 65 Years 2.Patients of either sex including transgender 3.The diagnosis of chronic tension type headache was based on The International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria for adults which were fulfilled for the past 3 months with symptoms onset at least 6 months before diagnosis.
- •E.g.- primed to expect ‘homoeopathic aggravation’ and available treatment options for the disease conditions, intimated through Patient Information Sheet.
排除标准
- •1.Criteria for migraine, Trigeminal autonomic cephalalgias or Other primary headache disorders fulfilled as per ICHD 3 for adults 2.Patients suffering from the complications of Tension Headache 3.Patients who are undergoing treatment with non-steroidal anti-inflammatory drugs (NSAIDs), antiemetic, or oestrogen during 2 weeks prior to enrolment in the study.
- •4.Diagnosed case of Cluster headache, Sinusitis, Brain aneurysm, Brain Tumour and Many other Pathologies 5.Has a history of structural abnormality of the Head or a disease or condition that can affect Headache 6.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 7.Patient under tobacco chewing and/or smoking, alcoholism and/or any other form(s) of substance abuse and/or dependence.
- •8.Self-reported immune – compromised state 9.Pregnant and puerperal women, and lactating mothers.
- •10.Patients who are too sick for consultation 11.Simultaneous participation of any other clinical trials.
- •12.Undergoing homoeopathic treatment for any chronic disease within the last 6 months.
结局指标
主要结局
Headache Disability Index, It measures specific symptoms of patients with Headache, consists of 25 Item Beta Version sub grouped into Functional and Emotional Subscale
时间窗: Baseline and Every Month till 3 Months
次要结局
- EQ-5D-5L, it is a standardized questionnaire used to measure health-related quality of life.(Baseline and Every Month till 3 Months)
研究者
Krishanu Panja
The Calcutta Homoeopathic Medical College & Hospit