Health Condition 1: G431- Migraine with aura
Conditions
Interventions
None listed
Sponsors
Dr Sheela Karalam B
Eligibility
Inclusion criteria
Inclusion criteria: 1.Documented history of migraine-related headaches with or without aura on fewer than 15 days per month for more than one year. 2.Participants with the MIDAS score: Grade II: Ranging from 6-10 & Grade III: Ranging from 11-20. 3. Patients with a HIT-6 score greater than 50. 4.Patients experiencing VAS score of 4 6 and PSQI score greater than 5. 5.Migraine Days Per Month (MDPM): Fewer than 15 migraine days per month. 6.Commitment to maintain a headache diary and accurately record headache frequency, duration, intensity, and associated symptoms. 7.Ability to provide written informed consent and comply with study procedures.
Exclusion criteria
Exclusion criteria: 1. Chronic Migraine (CM): Headache occurrence of more than 15 days per month. 2. Patient with the history of recent medication use within the past 4 Weeks such as migraine prophylactic agents before the start of baseline observation period 2.Headaches Other Than Migraine: Presence of other primary or secondary headache disorders. 3. The participants with known history of severe primary Psychiatric disorders (Depression, Anxiety, Psychosis) with Generalized Anxiety Disorder (GAD) score greater than14, major medical illness (Renal, Hepatic, Neurological and Cardiac diseases), Pregnancy, 4. Patients with known history of severe uncontrolled systemic disorders such as Hypertension, Cardiac problems, Diabetes Mellitus, Tuberculosis, Leprosy, Paralysis, and malignant disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in MIDAS, HIT, PSIQ, VAS score Changes in the monthly migraine days Timepoint: Improvement in MIDAS, HIT, PSIQ, VAS score Changes in the monthly migraine days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Changes in severity, rescue medication use, MSQ score for quality of life 2. Safety assessments and laboratory investigationsTimepoint: 1. Baseline, fourth week, eighth week. twelfth week 2. Baseline and twelfth week | — |
Countries
India
Contacts
Public ContactDr Dileep K S
Vaidyaratnam Ayurveda Research Institute
Outcome results
None listed