Validation of Unani Pharmacopoeial formulation- Habb-e- Shifa for symptomatic relief in patients of Nazla-e- HÄr (Common Cold)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 540
- 试验地点
- 7
- 主要终点
- Improvement in signs and symptoms of Nazla-e- HÄr (Common Cold)
研究概览
简要总结
This study is designed as a multicentric open trial in patients with Nazla-e- HÄr (Common Cold). After screening, Patients will be enrolled if they satisfy the inclusion and exclusion criteria. The patients will be assessed clinically on follow up. This includes subjective assessment of general well being and physical examination. The total duration of treatment will be 1 week . Laboratory parameters for safety assessment will be conducted at baseline and end of study.
1-TukhmDhatura Siyah (Datura stramoniumLinn.) 3 Parts
2-RewandChini (Rheumofficinale Baill.) 2 Parts
3-Zanjabil (Zingiberofficinale Roscoe) 1 Part
4-Samagh Arabi (Acacia nilloticaWilld.) 1 Part
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •All subjects should meet the following criteria: 1-Patients of either sex in the age group of 18-65 2- Patients of Nazla-e- HÄr (Common Cold) presenting with recent onset of any of the following symptoms: •KhushÅ«na al-Halaq (Sore throat) •Buhha al-Sawt (Hoarseness of Voice) •‘UtÄs (Sneezing/ Nasal irritation) •SudÄ‘ (Headache) •Su‘Äl (Cough) •Runny nose •I‘yÄ (Malaise) •Flushing of Face •With or without low grade fever (<102 0F).
排除标准
- •Patients will be excluded if they meet any of the following criteria:
- •Patients of acute or chronic lower respiratory tract infection like pneumonia, Bronchitis, Asthma and Bronchiectasis.
- •Fever 102oF
- •Known cases of any other acute illness
- •Pregnant and lactating women
- •Known case of Renal/ Hepatic/ Cardiac impairment or the ailment needs long term therapy.
结局指标
主要结局
Improvement in signs and symptoms of Nazla-e- HÄr (Common Cold)
时间窗: 1 week
次要结局
- Haematological and biochemical assessment for safety assessment(1 WEEK)