Homoeopathic treatment of Migraine
- Conditions
- Migraine, unspecified,
- Registration Number
- CTRI/2022/07/044049
- Brief Summary
Migraine is a common disabling primary headache disorder. Previous epidemiological studies have documented its high prevalence and socio-economic and personal impact in quality of life of an individual. It affects ~15% of the population, during the formative and most productive periods of their lives between the ages of 22 and 55 years. In the Global Burden of Diseases (GBD) 2010, it was ranked as the third most prevalent disorder in the world. In GBD 2015, it was ranked the third-highest cause of disability worldwide in both males and females under the age of 50 years. Patient suffering as well as recommendations to start conventional medication early have resulted in headaches from medication overuse, which is a major health problem (not in the least from the side-effects) with a prevalence of about 1%.However, the conventional treatment are not always fully effective and some have marked adverse effects. Because of this, many patients suffering from migraine may try alternative therapies such as homeopathy. Homeopathy may hold promise in successful treatment of migraine, but has remained under/poor researched. In this double-blind, randomized, placebo-controlled, clinical trial at Madhav Homoeopathic medical college and hospital, Abu road, Rajasthan 86 patients will be randomized to either individualized homoeopathic medicines or placebo to examine whether individualized homoeopathic medicines have any different effect from placebo in treatment of migraine. The frequency, duration and intensity of migraine attack will be assessed at baseline, every month and up to the 06 month by Diagnostic Headache Diary (DHD). The Migraine disability and quality of life of patients will be assessed at baseline, 03months and after 06 months by Migraine Disability Assessment Questionnaire (MIDAS), EQ-5D-5L and EQ-VAS Questionnaire scores. Comparative analysis will be carried out to examine group differences, if any. Results will be published in scientific journals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 86
-
- Subjects who has diagnosed as per the International classification of Headache disorders diagnostic criteria.
- 3 for Migraine. 2. Subjects will be selected irrespective of their sex, socio-economic status and occupation. 3. Age between 18 to 50 years. 4. If the subject is illiterate then the relatives or family members will be assessed to fill the headache diary. 5. Subjects who are willing to participate and sign the written informed consent form.
- Subjects suffering from the complications of migraine.
- Suspected secondary headache (trauma, headache attributed to vascular or non vascular intracranial disorders, medication overuse headache, hypertension).
- Subjects are undergoing treatment with non-steroidal anti inflammatory drugs (NSAIDS), antiemetic, triptans, ergot alkaloids and oestrogen during 2 weeks prior to enrollment in the study.
- Subjects suffering from uncontrolled systemic illness or psychiatric diseases and/or life-threatening infections.
- Substance abuse and/or dependence.
- Pregnant or lactating women.
- Subjects already undergoing homoeopathic treatment elsewhere for any chronic disease within last 02 months.
- Non-compliance to the study treatment/ protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diagnostic Headache Diary (DHD) Baseline, every month, up to 6 months
- Secondary Outcome Measures
Name Time Method Migraine Disability Assessment Questionnaire (MIDAS) Baseline, 3 months, 6 months EQ-5D-5L and EQ-VAS Questionnaire Baseline, 3 month, 6 months
Trial Locations
- Locations (1)
Madhav Homoeopathic Medical College and Hospital
🇮🇳Sirohi, RAJASTHAN, India
Madhav Homoeopathic Medical College and Hospital🇮🇳Sirohi, RAJASTHAN, IndiaDr Hanuman RamPrincipal investigator9462279933drhrchoudhary@gmail.com