A Randomized Comparative Clinical Study Of Polyherbal Unani Formulation And Sharbat e Banafsha In The Management Of Waram Tajawif Al Anf Muzmin(Chronic Rhinosinusitis)
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
- 主要终点
- Visual Analog Scale(VAS)
研究概览
简要总结
The study titled “A Randomized Comparative Clinical Study of Polyherbal Unani Formulation and Sharbat-e-Banafsha in the Management of Waram Tajawif al-Anf Muzmin (Chronic Rhinosinusitis)” aims to evaluate and compare the therapeutic efficacy of two Unani treatments—Joshanda (a polyherbal decoction) and Sharbat-e-Banafsha—in managing chronic rhinosinusitis, a persistent inflammation of the nasal and sinus mucosa. Chronic rhinosinusitis significantly affects quality of life and is often difficult to manage using conventional therapies, which involve prolonged use of antibiotics and steroids with potential side effects. This randomized, open-label clinical study will be conducted on 60 patients between 20–50 years of age, divided into two equal groups. The research involves both subjective (nasal obstruction, discharge, headache, etc.) and objective parameters (X-ray PNS, AEC), assessed through tools like the Visual Analogue Scale and SNOT-22 questionnaire. The study explores the Unani perspective of the disease, its classification, etiology, and traditional treatments, aiming to establish safer, cost-effective, and evidence-based alternatives for managing this chronic condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of either gender.
- •2.Patients in age group of 20-50 years.
- •3.Duration of the disease more than 12 week.
- •4.Patient having atleast two out of four cardinal symptoms(i.e., facial pain/pressure,hyposmia/anosmia,nasal obstruction,and nasal discharge for atleast 12 consecutive weeks.
- •5.Positive X-ray PNS finding(Thickened mucosal lining;opacity of sinus) 6.Those who give written informed consent.
排除标准
- •1.Patient aged less than 20 years or more than 50 years.
- •2.Patients suffering from any congenital or acquired structural abnormalities like nasal dermoid cysts, deviated nasal septum, atrophic rhinitis, hypertrophic turbinates, adenoidal hypertrophy, and foreign bodies.
- •3.Pregnant or lactating women.
- •4.Patients suffering from systemic illness like hypertension, diabetes mellitus, malignancy, liver, and kidney dysfunction.
- •5.Patient not willing to attend regular treatment and follow-up for the entire duration of study.
结局指标
主要结局
Visual Analog Scale(VAS)
时间窗: 2nd,4th and 6th week from baseline.
SNOT-22 questionnaire for QOL
时间窗: 2nd,4th and 6th week from baseline.
次要结局
- X RAY (PNS) - Water’s View(Absolute Eosinophil Count (AEC))
研究者
Malik Nusrat Fatima
State Unani Medical College Himmatganj Prayagraj Uttar Pradesh Pin Code 211016