Randomized Trial for Comparison between amitriptyline alone and amitriptyline with topiramate combination in chronic migraine ,whether single drug is better or combination of these 2 drugs
- Conditions
- Health Condition 1: G437- Chronic migraine without auraHealth Condition 2: G438- Other migraine
- Registration Number
- CTRI/2021/05/033356
- Lead Sponsor
- Principal Investigator Prof Jayantee Kalita
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
patients with chronic migraine attending neurology service will be included
diagnosis of chronic migraine will be based on ICHD-3 beta criteria (2013)-
adults >18 to <55 years of age
h/o at least 8 attacks of migraine (with or without aura )per month in last 3 months
h/o >15 headache days per month for >3 months
history of migraine (with or without aura)for >12 months prior to enrollment
patients with uncontrolled diabeties/hypertension ,heart diseases,psychiatric disease,seizures,hearing deficit,ear disease,visual deficit,stroke like illness,infection,organ failure,malignancy,asthamatics,immunosuppressant,systemic disease,age <18 or >55 years ,migraine onset after 50 years of age ,on prophylactic treatment in past one month ,abortive medication with opioid drugs,pregnancy,and unwilling for consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method primary outcome-more than 50% reduction in headache days <br/ ><br>secondary outcome- <br/ ><br>severity in vas score <br/ ><br>number of abortive medication <br/ ><br>mMIDAS SCORE <br/ ><br>Migraine physical function impact diary <br/ ><br>severe adverse eventsTimepoint: base line ,ist and 3rd month
- Secondary Outcome Measures
Name Time Method severity in vas score <br/ ><br>number of abortive medication <br/ ><br>mMIDAS SCORE <br/ ><br>Migraine physical function impact diary <br/ ><br>severe adverse eventsTimepoint: baseline ,ist and 3rd month