Comparative therapeutic evaluation of unani coded formulations with and without Munzij & Munshil Therapy in cases of Sinusitis (Iltehab-e-Tajaweef-e-Anaf)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Safety evaluations:
研究概览
简要总结
Sinusitis is a clinical condition which is globally prevalent and affects large population in all age groups.
The treatment in conventional modern system of medicine mostly consists of antibiotics, anti histemenic and decongestants which does not cure all, necessitating surgical interventions in good no. of patients which too does not provide complete and irreversible relief. hence it is of paramount importance to search new and safe therapies for the effective management of this disease.
Ancient unani physicians have been treating different types of nazla including nazla-e-barid- muzmin. The symptomatology of which corresponds to sinusitis. Keeping this in view the present study has been planned and the trial drugs have proved safe and efficacious in the management of this disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with radiologically confirmed sinusitis Presence of any one of the signs and symptoms:
- •Nasal discharge
- •Nasal obstruction,
- •Deviated and hypertrophied nasal septum.
排除标准
- •patients with PAN sinusitis
- •Hepato renal, cardio pulmonary disorders
- •Pregnant and lactating women
- •those on oral contraceptives
- •those on active treatment from other systems of medicine.
结局指标
主要结局
Safety evaluations:
时间窗: Baseline, 15th days, 30th days, 45th days, 60th days, 90th days.
Efficacy evaluations:
时间窗: Baseline, 15th days, 30th days, 45th days, 60th days, 90th days.
Radiological clearance of sinuses.
时间窗: Baseline, 15th days, 30th days, 45th days, 60th days, 90th days.
2. improvement in the following signs and symptoms: Nasal discharge, sneezing, headache, nasal obstruction, malaise.
时间窗: Baseline, 15th days, 30th days, 45th days, 60th days, 90th days.
clinical laboratory tests: LFT, RFT, AE/ ADR reporting
时间窗: Baseline, 15th days, 30th days, 45th days, 60th days, 90th days.
次要结局
- Safety measures pathological and biochemical investigations(Before and after treatment)