A Clinical valuation of efficacy and safety of Unani Formulation in Warm Tajawif al-Anf Muzmin (Chronic Sinusiti).
- Conditions
- Health Condition 1: J32- Chronic sinusitisHealth Condition 2: F01-F99- Mental, Behavioral and Neurodevelopmental disorders
- Registration Number
- CTRI/2023/03/050256
- Lead Sponsor
- ational Research Institute of Unani Medicine for Skin Disorders, Hyederabad
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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).
1. Patient aged < 18 years or >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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the Grading of X-ray PNS (Thickened mucosal lining, opacity of sinus) <br/ ><br>Reduction in SNOT-22 Score <br/ ><br>Reduction in VAS Score <br/ ><br>Reduction in Serum Level of Ig E <br/ ><br>Timepoint: 42 days
- Secondary Outcome Measures
Name Time Method Systemic Safety AssessmentTimepoint: 42 days