Health Condition 1: J32- Chronic sinusitis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1- Participants Of Either Gender Aged 18 To 60 Years 2- Participants Fulfilling AAO HNS (American Academy Of Otolaryngology Head And Neck Surgery) Criteria: Twelve Weeks Or Longer Of Two Or More Of The Following Signs And Symptoms: a) Mucopurulent Drainage (Anterior, Posterior, Or Both) b) Nasal Obstruction (Congestion) C) Facial Pain, Pressure, Or Fullness d) Decreased Sense Of Smell e)Inflammation Documented By One Or More Of The Following: i) Purulent (Not Clear) Mucus Or Edema In The Middle Meatus Or Anterior Ethmoid Region ii) Polyps In Nasal Cavity Or Middle Meatus or Radiographic Imaging Showing Inflammation Of Paranasal Sinuses 3- Ability To Understand And Provide Written Informed Consent 4- Willingness To Attend Follow Up Visits As Per Protocol
Exclusion criteria
Exclusion criteria: 1 Age Below 18 Years Or Above 60 Years 2 Pregnant Or Lactating Women 3 Significant Pulmonary, Cardiovascular, Hepato Renal Dysfunctions Or Chronic Diseases Requiring Long Term Treatment 4 Known Cases Of Immunocompromised States Such As HIV Or AIDS 5 Known Hypersensitivity To Study Drug Or Any Of Its Ingredients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1- Change In SNOT 22 Score From Baseline To 6 Weeks Of Treatment 2- Change In VAS Score From Baseline To 6 Weeks Of Treatment Timepoint: 2 and 4 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation Of Safety 1- By Monitoring Adverse Events Related To Either Unani Drug Or Control Drug Documented At Each Clinical Assessment Visit (Week 2, Week 4, Week 6) As Reported By Participants And Observed By Physician 2 Change In Radiological Findings Assessed By X Ray PNS (Waters View) From Baseline To End Of 6 Weeks Of Treatment 3- Change In Laboratory Parameters From Baseline To Week 6 Including: Haemogram (Hb, TLC, DLC, RBC Count, Platelet Count, ESR) Liver Function Tests (Serum Bilirubin, SGOT, SGPT, Serum Alkaline Phosphatase) Kidney Function Tests (Serum Creatinine, Blood Urea) 4- Urine Examination (Routine And Microscopic) Timepoint: 2 and 4 Weeks | — |
Countries
India
Contacts
National Research Institute of Unani Medicine For Skin Disorders