Clinical Validation of Unani Pharmacopoeial Formulation ItrifalKishneezi in Nazla Muzmin (Chronic RhinoSinusitis)
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 240
- Locations
- 3
- Primary Endpoint
- Improvement in sign and symptoms of Nazla Muzmin (Chronic RhinoSinusitis)
Study Overview
Brief Summary
This study is designed as a multicentric open trial in patients with **Nazla Muzmin (Chronic RhinoSinusitis)****.**After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at every week. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 4 weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
Composition of Itrifal Kishneezi
| S. No. |
Ingredients
Botanical / Scientific Name
Quantity
|1.
Post- Halela Zard
Terminalia chebula Retz
100gm
|2.
Post-Halela Kabli
Terminalia chebula Retz
100gm
|3.
Halela Siyah
Terminalia chebula Retz
100gm
|4.
Aamla
Emblica officinalis Gaertn
100gm
|5.
Post-e-Balela
Terminalia bellirica Roxb.
100gm
|6.
Kishneez Khushk
Coriandrum sativum Linn.
100gm
|7.
Asal / Qand Safaid
Honey / Sugar
1.8 kg
|8.
Raughan-e-Badam / Raughan-e-Zard
Almond oil / Purified Ghee
Q.S
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients of either sex of age 18-65 years
- •Patients with Sino-Nasal Outcome Test (SNOT) > 7
- •Patients clinically diagnosed of sinusitis of duration > 12 weeks with radiological changes.
Exclusion Criteria
- •Patients of sinusitis with epistaxis, hypertension shall be excluded from the study
- •Patient having any growth in the nose like nasal polyps etc.
- •Patients with co-morbidity requiring long term treatment.
- •Pregnant and lactating females.
Outcomes
Primary Outcomes
Improvement in sign and symptoms of Nazla Muzmin (Chronic RhinoSinusitis)
Time Frame: 04 Weeks
Secondary Outcomes
- Haematological and biochemical assessment for safety assessment(Investigations will be done at baseline and end of treatment)