Clinical trial of Unani coded formulations in cases of sinusitis

Phase 2

Completed

• Conditions: Sinusitis

• Registration Number: CTRI/2018/05/014151
• Lead Sponsor: Central Council for Research in Unani Medicine

Brief Summary

Sinusitis is a clinical condition which is globally prevalent and affects large population in all age groups.

The treatment in conventional modern system of medicine mostly consists of antibiotics, anti histemenic and decongestants which does not cure all, necessitating surgical interventions in good no. of patients which too does not provide complete and irreversible relief. hence it is of paramount importance to search new and safe therapies for the effective management of this disease.

Ancient unani physicians have been treating different types of nazla including nazla-e-barid- muzmin. The symptomatology of which corresponds to sinusitis. Keeping this in view the present study has been planned and the trial drugs have proved safe and efficacious in the management of this disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01-10
• Study Completion: 2016-12-26
• Last Update Posted: 2018-05-19

Recruitment & Eligibility

• Status: Completed
• Sex: All
• 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.
• Deviated and hypertrophied nasal septum.

Exclusion Criteria

• 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:	Baseline, 15th days, 30th days, 45th days, 60th days, 90th days.
Radiological clearance of sinuses.	Baseline, 15th days, 30th days, 45th days, 60th days, 90th days.
2. improvement in the following signs and symptoms: Nasal discharge, sneezing, headache, nasal obstruction, malaise.	Baseline, 15th days, 30th days, 45th days, 60th days, 90th days.
Safety evaluations:	Baseline, 15th days, 30th days, 45th days, 60th days, 90th days.
clinical laboratory tests: LFT, RFT, AE/ ADR reporting	Baseline, 15th days, 30th days, 45th days, 60th days, 90th days.

Secondary Outcome Measures

Name	Time	Method
Safety measures pathological and biochemical investigations	Before and after treatment

Trial Locations

Locations (1)

Central Research Institute of Unani Medicine; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Central Research Institute of Unani Medicine

🇮🇳Hyderabad, ANDHRA PRADESH, India

Dr Musheer Ahmed

Principal investigator

9848716693

drmusheercrium@gmail.com