Comparative study of physicochemical profiles of natrum muriaticum 3x trituration and tablet prepared manually and mechanically and a pilot open-label non-randomized clinical trial of natrum muriaticum in centesimal potencies versus individualized homoeopathy in chronic migraine
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
Chronic migraine is a disabling primary headache disorder, defined by the International Classification of Headache Disorders, 3rd edition (ICHD-3), as a headache occurring on 15 or more days per month for more than three consecutive months, of which at least eight days per month must involve migraine features such as throbbing pain, photophobia, phonophobia, or nausea and/or vomiting. The objective of the trial is to compare the therapeutic efficacy of Natrum muriaticum in centesimal potencies with individualized homoeopathic prescriptions in patients suffering from chronic migraine in a pilot open-label quasi-experimental study. The primary assessment tool is Migraine Disability Assessment Scale (MIDAS) to assess impact on daily functioning and the secondary assessment tools are Visual Analogue Scale (VAS) for headache intensity and frequency of chronic headache attacks. All the assessments are done at the baseline and after three months.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged between 18 and 60 years.
- •A clinical diagnosis of chronic migraine, defined as headache occurring on 15 or more days per month for a duration of at least three consecutive months.
- •On at least 8 days/month, the headache should fulfill criteria for migraine without aura (1.1), or respond to migraine-specific treatment (e.g., triptans, ergot derivatives)., in accordance with the International Classification of Headache Disorders, 3rd edition (ICHD-3).
- •MIDAS score is greater than or equal to
- •Willingness to provide written informed consent and comply with study procedures.
- •Not taking any other homeopathic treatment during the study period.
- •Willing to report and refrain from starting new allopathic or alternative interventions for migraine during the study.
排除标准
- •Presence of a secondary headache disorder (e.g., attributed to trauma, vascular disorders, intracranial neoplasms, infections, substance use/withdrawal, or psychiatric illness, as defined by ICHD-3 (e.g., code 6–12).
- •Other Primary Headache Disorders: Diagnosed with cluster headache, chronic tension-type headache without migraine features, medication overuse headache, or hemiplegic/basilar migraine.
- •Severe Uncontrolled Comorbidities: Uncontrolled hypertension, diabetes mellitus, renal, hepatic, or cardiac diseases that may interfere with study outcomes.
- •Coexisting severe psychiatric conditions (such as History of major depression, bipolar disorder, or schizophrenia etc.) that may interfere with assessment.
- •Pregnancy or lactation.
- •Use of ongoing prophylactic headache medication that cannot be safely discontinued.
- •Unwillingness to adhere to study protocol or provide written informed consent.
- •Concurrent enrollment in another clinical trial within the last 3 months.
研究者
Subhashree Modak
The Culcutta Homoeopathic Medical College and Hospital