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Effect of Unani Formulations in Migraine headache

Phase 2
Conditions
Health Condition 1: G00-G99- Diseases of the nervous system
Registration Number
CTRI/2023/05/052944
Lead Sponsor
ational Institute of Unani Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

1.Diagnosed cases of Migraine without Aura (as per the International Classification of Headache Disorders (ICHD-3) with history for at least one year

2.Patients between the age of 18â??50 years

3.Patients of any gender

4. Patients who will give consent and are able to do follow up

Exclusion Criteria

1.Headache other than Migraine without Aura

2.Use of any migraine prophylactic agents (b-blockers, anti-depressants, calcium channel blockers, anti-epileptic agents, cycle-modulating hormonal drugs, or vessel dilatation agents) within 1 month prior to screen

3.History or evidence of psychiatric disorder

4.Patients with a score of 19 or higher on the Beck Depression Inventory-II (BDI-II)

5.History of any systemic illness

6.Pregnant and lactating women

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
50% Reduction in Monthly Migraine Days (MMD) <br/ ><br> <br/ ><br>Timepoint: 0th, 30th and 60th day <br/ ><br> <br/ ><br>
Secondary Outcome Measures
NameTimeMethod
oReduction in the Headache Impact Test (HIT-6) <br/ ><br>oIncrease in the Migraine-Specific Quality of Life Questionnaire version 2.1 (MSQv2.1) <br/ ><br>Timepoint: 0th, 30th and 60th day
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