Health Condition 1: G439- Migraine, unspecified
Conditions
Interventions
None listed
Sponsors
CCRAS
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients of either sex aged in between 18 to 60 years. 2. Diagnosed cases of Migraine with or without aura as per International Headache Society-ICHD-III (International classification of Headache Disorders 3rdversion). 3. Patients with up to Grade III severity as per MIDAS scale. 4. Willing to participate in the study
Exclusion criteria
Exclusion criteria: 1. Patients who were suffering from headache due to space occupying lesions and other secondary reasons. 2. Patients with concurrent serious cardiac, Hepatic Dysfunction (defined as AST and/or ALT > 2 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine > 1.2mg/dl), uncontrolled Pulmonary Dysfunction (Asthmatic and COPD patients) or other concurrent severe disease. 3. Patients with evidence of malignancy 4. Known cases of psychosis, depression, schizophrenia and other psychiatric illness etc. 5. Patients on �² blockers and Calcium channel blockers and or on prophylactic medicine for migraine. 6. Patients with uncontrolled Hypertension (BP >160/100 mm of Hg) 7. Patients with uncontrolled Diabetes mellitus {HbA1c > 8%). 8. Patients suffering from any major systemic illness necessitating long term drug treatment. 9. Pregnant women or planning to conceive or lactating woman. 10. Any other condition which the Principal Investigator thinks may jeopardize the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the character of disease in terms of frequency (No. of migraine episodes), intensity of headache as per VAS (0-10) and duration of episode of headacheTimepoint: At Screening, Baseline, 4th week, 8th week, 12th week, 16th week, 20th week. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Changes in MIDAS [Migraine Disability Assessment Score]. 2. Changes in MSQ2.1 [Migraine specific quality of life survey]. 3. Change in associated symptoms of migraine. 4. Use of analgesics/symptom alleviating medication. 5. Change in the required dose/withdrawal of Anti-hypertensive drugs if any. Timepoint: 1. MIDAS- At screening, at the end of 16th week 2. MSQ 2.1- At baseline, at the end of 4th, 8th, 12th, 16th & 20th week 3. Change in associated symptoms of migraine- At baseline, at the end of 4th, 8th, 12th, 16th & 20th week 4. Use of analgesics/symptom alleviating medication- At baseline, at the end of 4th, 8th, 12th, 16th & 20th week 5. Change in the required dose/withdrawal of Anti-hypertensive drugs if any- At baseline, at the end of 4th, 8th, 12th, 16th & 20th week | — |
Countries
India
Contacts
Public ContactDr Shweta Chaudhary
Central Council for Research in Ayurvedic Sciences
Outcome results
None listed