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Treatment of headache (on one side of head) with Unani medicine Capsule Shaqiqa

Single blind,Randomized, Parallel group study to compare efficacy and safety of Unani formulation Capsule Shaqiqa with Divalproate in patients with Shaqiqa (Migraine)

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/06/034390
Enrollment
60
Registered
2021-06-25
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G439- Migraine, unspecified

Interventions

Intervention1: Capsule Shaqiqa: Two capsules (500mg each) orally twice a day to be taken with water for 12 weeks Control Intervention1: Tablet Divalproate: 250 mg (body weight 30kg) OR 850mg (body wei

Sponsors

Central Council for Research in Unani Medicine CCRUM New Delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of either gender in the age group 18- 65 years 2. Primary diagnosis of Migraine without aura by ICHD-3 beta as follows: A. At least five attacks fulfilling criteria Bâ??D. B. Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated). C. Headache has at least two of the following four characteristics: Unilateral location Pulsating quality Moderate or severe pain intensity Aggravation by or causing avoidance ofroutine physical activity (e.g. walking or climbing stairs). D. During headache at least one of the following: 1. Nausea and/or vomiting. 2. Photophobia and phonophobia. E. Not better accounted for by another ICHD-3diagnosis.

Exclusion criteria

Exclusion criteria: 1. Known case of any structural brain abnormalities 2. Known case of Ocular disease 3. History of Ischaemic stroke 4. Any disease involving sinus e.g. Rhinosinusitis 5. Systemic illness requiring long term treatment 6. Known cases of Chronic kidney & liver disease 7. Known cases of Psychiatric illness 8. Difficulty distinguishing migraine headache from other headaches 9. Known cases of Epilepsy and other neurological disorders 10. History of alcohol and drug abuse. 11. Pregnancy & lactation

Design outcomes

Primary

MeasureTime frame
Improvement in signs and symptoms of Shaqiqa (Migraine)Timepoint: The patients will be assessed clinically at baseline and at every two weeks till the completion of the trial i.e. upto 12 weeks

Secondary

MeasureTime frame
Haematological and biochemical assessment for safety assessmentTimepoint: At baseline and at every two weeks till the completion of the trial i.e. upto 12 weeks

Countries

India

Contacts

Public ContactDr Pradeep Kumar

Central Council for Research in Unani Medicine (CCRUM)

ccrum507@rediffmail.com9213511298

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026