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A Clinical valuation of efficacy and safety of Unani Formulation in Warm Tajawif al-Anf Muzmin (Chronic Sinusiti).

A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to evaluate the Efficacy and Safety of a Polyherbal Unani Formulation in the Management of Waram TajaÌ?wiÌ?f al-Anf Muzmin (Chronic Sinusitis)

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/050256
Enrollment
64
Registered
2023-03-02
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

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 Health Condition 2: F01-F99- Mental, Behavioral and Neurodevelopmental disorders

Interventions

Intervention1: Polyherbal Unani Formulation: Dosage Form: Decoction Using Raw Drugs Dose: 45gm Daily One Time Duration: 42 days Route of Administration: Oral Composition of Formulation: 1- Aslussoos (

Sponsors

National Research Institute of Unani Medicine for Skin Disorders, Hyederabad
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Duration of the disease >12 week. 2. Patient having at least two out of four cardinal symptoms (i.e., facial pain/pressure, hyposmia/anosmia, nasal obstruction, and nasal discharge for at least 12 consecutive weeks. 3. Patient having other symptoms rhinorrhea, nasal congestion, frontal headache, nasal itching, impaired sense of smell and frequent sneezing for more than 12 weeks. 4. Positive X-ray PNS finding (Thickened mucosal lining, opacity of sinus).

Exclusion criteria

Exclusion criteria: 1. Patient aged 50 years. 2. Patient with deviated nasal septum(DNS). 3. Local pathology such as mucocele, cyst, antrochoanal polyp, facial trauma. 4. Diabetes mellitus and any other illness requiring long term treatment. 5. Pregnant or Lactating Women. 6. Significant Pulmonary/Cardiovascular/Hepato-renal Dysfunction 7. Known cases of Immunocompromised states (HIV/ AIDS, etc.)/Malignancies. 8. Patient not willing to attend regular treatment and follow-up for the entire duration of study. 9. Mentally retarded patients. 10.Patient having history of any surgery of nose or paranasal sinuses. 11. Patient having history of trauma to nose or sinus area. 12. Patient of pulmonary Kochâ??s or having history of epistaxis. 13. Any medical condition where physician feels that participation in the study could be detrimental to patientâ??s well being. 14. Alcoholic and Drug addicted patient. 15. Patient having allergy of controlled drug or with any of the ingredients of test drug.

Design outcomes

Primary

MeasureTime frame
Change in the Grading of X-ray PNS (Thickened mucosal lining, opacity of sinus) Reduction in SNOT-22 Score Reduction in VAS Score Reduction in Serum Level of Ig E Timepoint: 42 days

Secondary

MeasureTime frame
Systemic Safety AssessmentTimepoint: 42 days

Countries

India

Contacts

Public ContactFazila Nawab

National Research Institute of Unani Medicine for skin disorders

ccrumnawab@gmail.com8100992044

Outcome results

None listed

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