To Evaluate The Clinical Efficacy Of Polyherbal Unani Formulation in The Management of Waram Al Lawzatayn Muzmin(Chronic Tonsillitis).
Overview
- Phase
- Phase 2/3
- Status
- Not yet recruiting
- Sponsor
- State Unani Medical College and HAHRDM Hospital Himmatganj Prayagraj
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Reduction in clinical scoring system
Overview
Brief Summary
The proposed clinical study aims to evaluate the effectiveness of a polyherbal Unani formulation in managing Waram al-Lawzatayn Muzmin (Chronic Tonsillitis), a common ENT condition marked by recurrent throat infections, especially among children and young adults. Modern treatments like antibiotics offer temporary relief and come with side effects, often leading to surgical intervention such as tonsillectomy. In contrast, Unani medicine offers natural, safer alternatives with minimal adverse effects. Drawing from classical Unani texts and modern clinical observations, this study involves a 6-week, open-label, pre-post interventional trial with 50 patients aged 18–50 years. Participants will receive a herbal decoction comprising ingredients like Anjeer, Marzanjosh, Qust, Tulsi, and others. The study will assess efficacy based on clinical symptoms and laboratory parameters, aiming to explore a holistic, effective, and safer long-term approach to treating chronic tonsillitis through Unani medicine.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 50.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Patients of either gender in the age group of 18-50 years.
- •2.Clinically diagnosed cases of Waram-e-Lawzatayn Muzmin (chronic tonsillitis)
- •Clinical Scoring System Severe- 9 or greater than
- •Moderate- 4-8 Mild- 3 or less than 3.
Exclusion Criteria
- •1.Patients aged below 18 years and more than 50 years 2.Pregnant and lactating women 3.Patient with any complication of tonsillitis 4.Tonsillitis associated with any other systemic, metabolic, or chronic disease 5.Patient ’s unsure about attending schedule regularly.
Outcomes
Primary Outcomes
Reduction in clinical scoring system
Time Frame: 7,14,21,28,35,and 42 days from baseline
Secondary Outcomes
- Improvement in patient global assessment on Visual Analog Scale (VAS)(7,14,21,28,35 and 42 Days from baseline)
Investigators
KM Nasreen
State Unani Medical College Himmatganj Prayagraj Uttar Pradesh Pin Code 211016