To evaluate the Safety and efficacy of Unani formulations in the treatment of Headache
- Conditions
- Health Condition 1: R51- HeadacheHealth Condition 2: null- Headache (SudÄ?)
- Registration Number
- CTRI/2015/03/005608
- Lead Sponsor
- Central Council for Research in Unani Medicine CCRUM New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 540
•Patients of either sex with age 18-65 years
•Patients having SudÄ?â?? (Headache) with or without any of the following symptoms:
ï?§Disturbed concentration
ï?§Irritability
ï?§Zuâ??f al-IshtihÄ?â?? (Decreased appetite)
ï?§Iâ??yÄ? (Fatigue)
ï?§Difficulty in falling asleep and staying asleep
ï?§Mild sensitivity to light/ noise
•Headache does not respond to standard therapy
•Headache accompanied by impaired neurological functions (loss of balance, weakness, numbness, or speech disturbances), double vision, seizures, mental disturbances, and loss of consciousness.
•Headache accompanied by persistent nausea, vomiting, fever and stiff neck
•History of recent head injury.
•Known cases of any other acute illness.
•Known cases of severe Renal/ Hepatic/ Cardiac ailments
•Pregnant and lactating women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in signs and symptoms of SudÄ?â?? (Headache)Timepoint: 7 days
- Secondary Outcome Measures
Name Time Method Haematological and biochemical assessment for safetyTimepoint: 7 days