Clinical trial of Unani coded formulations in cases of sinusitis
Phase 2
Completed
- Conditions
- Health Condition 1: null- Sinusitis
- Registration Number
- CTRI/2018/05/014151
- Lead Sponsor
- Central Council for Research in Unani Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
Patients with radiologically confirmed sinusitis
Presence of any one of the signs and symptoms:
1. Nasal discharge
2. Sneezing
3. Headache
4. Nasal obstruction,
5. Malaise
6. Deviated and hypertrophied nasal septum
Exclusion Criteria
1. patients with PAN sinusitis
2. Hepato renal, cardio pulmonary disorders
3. Pregnant and lactating women
4. those on oral contraceptives
5. those on active treatment from other systems of medicine
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy evaluations: <br/ ><br>Radiological clearance of sinuses. <br/ ><br>2. improvement in the following signs and symptoms: Nasal discharge, sneezing, headache, nasal obstruction, malaise. <br/ ><br>Safety evaluations: <br/ ><br>clinical laboratory tests: LFT, RFT, AE/ ADR reportingTimepoint: Baseline, 15th days, 30th days, 45th days, 60th days, 90th days.
- Secondary Outcome Measures
Name Time Method Safety measures pathological and biochemical investigationsTimepoint: Before and after treatment