Comparative Clinical Evaluation of Lauq Nazli vs Sharbat-e-Banafsha in the Management of Nazla Haar (Allergic Rhinitis):A Randomized clinical trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
Allergic rhinitis (Nazla Haar) is a highly prevalent immunological disorder characterized by sneezing, watery nasal discharge, nasal blockage, itching and eye irritation. It significantly impairs the patient’s daily functioning and quality of life. Although modern medicine offers antihistamines and decongestants, these treatments may cause sedation, rebound congestion or other adverse effects. Unani medicine describes Nazla Haar as the descent of hot morbid matter (bukharat/fuzlat) from the brain toward the nose and throat and several classical formulations, including Lauq Nazli and Sharbat-e-Banafsha, have been traditionally used for its management.
The present randomized, parallel-group, open-label clinical trial aims to evaluate and compare the efficacy and safety of Lauq Nazli and Sharbat-e-Banafsha in patients with Allergic Rhinitis. A total of 60 patients meeting ARIA-based inclusion criteria will be enrolled from the ENT OPD of State Unani Medical College & HAHRDM Hospital, Prayagraj and randomized equally into two groups.
Group A will receive Lauq Nazli (5 g orally, twice daily) and Group B will receive Sharbat-e-Banafsha (24 ml twice daily), both for 21 days, with follow-ups on days 7, 14, 21 and a post-treatment assessment on Day 28.
Efficacy will be measured using the Total Nasal Symptom Score (TNSS), Absolute Eosinophil Count and the Rhinitis Quality of Life Questionnaire (RQLQ). Safety assessment will include clinical examination and laboratory investigations. Data will be analyzed using intention-to-treat principles.
This study is expected to generate scientific evidence on the comparative therapeutic potential of two widely used Unani formulations and may provide safe, effective and affordable treatment options for Allergic Rhinitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Symptoms persisted for more than 4 days per week or more than 4 weeks per year and at least one of the following rhinitis-associated conditions-.
- •Nasal congestion.
- •Rhinorrhea.
- •Nasal itching 2 Patients who will give consent and able to do followup.
排除标准
- •1 Medical history of Diabetic, gastrointestinal disease, systemic illness like Hypertension.
- •2 Use of anti-biotic medication in the last 6 weeks.
- •3 Psychiatric or Neurological disease.
- •4 Patients suffering from congenital nasal abnormalities like Deviated Nasal Septum or perforation.
- •5 Perennial allergic rhinitis, chronic rhinosinusitis etc.
- •6 Patients had received systematically administered corticosteroids, antihistamine, decongestants or CAM therapy within 02 weeks before enrolment.
- •7 Pregnant and lactating women.
研究者
Umme Kulsum Tanzeem
State unani medical college