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A Clinical Study on Chronic Rhinosinusitis In Unani

A Randomized Parallel Group Open Label Active Controlled Clinical Study to evaluate the Safety and Efficacy of Unani Formulations Joshanda (Oral) and Takmid Muhallil (Local) compared with Levocetirizine in the Management of Waram Tajawif al- Anf Muzmin (Chronic Rhinosinusitis) - Nil

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/094728
Enrollment
60
Registered
2025-09-12
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Health Condition 1: J32- Chronic sinusitis

Interventions

Intervention1: Unani Formulations - 1 - Joshanda (Oral) 2- Takmid Muhallil (Locally): Details of Joshanda Intervention2: Unani Formulations - 1-Joshanda (Decoction Orally) 2- Takmid ( Hot Fomentati

Sponsors

National Research Institute of Unani Medicine For Skin Disorders
Lead Sponsor

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

MeasureTime 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

MeasureTime 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

Public ContactDr NAEEM AHMED SHAIKH IBRAHIM

National Research Institute of Unani Medicine For Skin Disorders

aarzu763@gmail.com9032519286

Outcome results

None listed

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