Health Condition 1: G439- Migraine, unspecified
Conditions
Interventions
Intervention1: Multi- Drug Migraine Capsule: Gowri Chinthamani Chendurum-50 mg twice a day after food
Arumuga Chendurum-50 mg twice a day after food
Sivanar Amirtham-50 mg twice a day after food
Thal
Sponsors
National Institute of Siddha
Eligibility
Inclusion criteria
Inclusion criteria: Participants aged 18 to 60 years diagnosed with Migraine as per ICHD-3 diagnostic criteria for primary headache disorders with duration history of migraine for greater than or equal to 12 months before screening. Latest reported attack history should at least be within past 40 days. Grades 1-4 in HURT Scale (mild, moderate, severe & very severe) will be included with or without ongoing standard migraine prophylaxis 0 (very mild): 0 days in 1 month or 0 days in 3 months; 1 (mild): 1 2 days in 1 month or 1 5 days in 3 months; 2 (moderate): 3 5 days in 1 month or 6 10 days in 3 months; 3 (severe): 6 15 days in 1 month or 11 20 days in 3 months; 4 (very severe): Greater than or equal to 16 days in 1 month or greater than or equal to 21 days in 3 months. Frequency of migraine attacks should be at least one migraine day / month or at least three migraine days in the last 3 months.
Exclusion criteria
Exclusion criteria: Pregnant / Lactating women and those planning for pregnancy. Patients with chronic systemic illness and vulnerable group. Confounding and clinically significant pain syndromes (e.g. fibromyalgia, chronic low back pain, complex regional pain syndrome). History of Psychiatric conditions that are uncontrolled and/or untreated, including conditions that are not controlled for a minimum of 6 months prior to screening. Patients with a lifetime history of psychosis, mania, or dementia are excluded. History or diagnosis of complicated migraine (ICHD-III beta version, 20134), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or sporadic and familial hemiplegic migraine. Organic lesions of head and neck conditions precipitating headaches (will be excluded through CT/ MRI & EEG). Participants with recent history (in the past 3 months) suggestive of alcohol or drug abuse more than 7 days in total or dependence, including overuse (abuse) of ergotamines and/or narcotics to treat migraines. Ergotamine abuse is daily use for 14 consecutive days or intermittent consumption exceeding 10 mg per week for any two weeks.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| The temporal difference in the Quality of Life of the patients with migraine using 24h MQoL-Q; Migraine-Specific Quality of Life Survey (MSQ 2.1), depression severity using Patient Health Questionnaire (PHQ-9); Becks Depression Inventory (BDI), anxiety using Hospital Anxiety and Depression Scale (HADS) and Migraine Aura using Visual Aura Rating Scale (VARS) will be analyzed between commencement, close and post treatment follow up in intermittent time points as the scale concerned warrants.Timepoint: At the end of 24 days | — |
Primary
| Measure | Time frame |
|---|---|
| Comparing the change in (1) frequency of episodes,(2) duration in hours / month, and (3) pain severity/disability scores using pain and disability scales from baseline to one year post intervention with monthly, quarterly intermittent time points as per the scales used.Timepoint: At the end of 24 days | — |
Countries
India
Contacts
Public ContactDr M Ramamurthy
National Institute of Siddha
Outcome results
None listed