Homoeopathic treatment of headache

Phase 2/3

Recruiting

Brief Summary: Migraine is defined as â€˜headache occurring on â‰¥15 days/month for > 3 months with features of migraine on â‰¥8 days/months. Presenting symptoms include throbbing pain either one-sided (usually) or bilateral, aggravated on least movement, associated with nausea, dizziness, extreme sensitivity to lights, noises, smell, lack of appetite, bowel disturbances and visual or sensory aura. It is included among top 40 conditions, which cause worldwide disability and it produces 3.63 times greater disability. Recent studies showed about 8.4% of Indian population is suffering from chronic migraine. There was no study conducted in past 10 yrs in homoeopathy on migraine. In this double-blind, randomized, placebo-controlled trial at The Calcutta Homoeopathic Medical College and Hospital, 60 patients suffering from chronic migraine will be randomized to either individualized homoeopathic medicines (verum; n=30) or identical looking placebo (control; n=30). We aim to examine whether there are any differences in outcomes between these two groups over 3 months of intervention. Monthly migraine days (MMD) scores, Migraine Disability Assessment Test (MIDAS) scores and EQ-5D-5L scores will be used as the primary and secondary outcome measures respectively, measured at baeline and every month up to 3 months. Comparative analysis will be carried out to detect group differences, if any. Results will be published in scientific journals.

Recruitment & Eligibility

Inclusion Criteria

Patients suffering from chronic migraine, that is, headache on 15 or more days/month for more than 3 months, with a feature of migraine headache on at least 8 days/month (ICD-10-CM Code G43.709) 2.
Patients of 18-65 years of age and of either sex 3.
Patients who have not taken any treatment since at least 2 weeks for migraine 4.
Literate patients; can read Bengali and/or English 5.
Providing written informed consent to participate in the trial.

Exclusion Criteria

Patients suffering from the complications of migraine 2.
Patients who are undergoing treatment with non-steroidal anti-inflammatory drugs (NSAIDs), antiemetic, or oestrogen during 2 weeks prior to enrolment in the study 3.
Other uncontrolled or unstable systemic or psychiatric diseases and/or infections affecting quality of life 4.
Patients who are too sick for consultation 5.
Pregnant and puerperal women, and lactating mothers 6.
Substance abuse and/or dependence 7.
Self-reported immune-compromised state 8.
Undergoing homoeopathic treatment for any chronic disease within last 6 months.

Primary Outcome Measures

Name	Time	Method
Monthly migraine days (MMD)	At baseline, every month, up to 3 months

Secondary Outcome Measures

Name	Time	Method
Migraine Disability Assessment Test (MIDAS) scores	At baseline, every month, up to 3 months
EQ-5D-5L scores	At baseline, every month, up to 3 months

Locations (1): The Calcutta Homoeopathic Medical College and Hospital
🇮🇳
Kolkata, WEST BENGAL, India
The Calcutta Homoeopathic Medical College and Hospital
🇮🇳Kolkata, WEST BENGAL, India
Tanaya Chanda
Principal investigator
8240167620
tanayachanda77@gmail.com