Clinical Validation of Unani Pharmacopoeial Formulation Lauq-e-Nazli in Nazla(Common Cold)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 试验地点
- 4
- 主要终点
- The patients will be assessed by subjective and objective clinical observations which will be recorded in the follow-up sheet.
研究概览
简要总结
This study is designed as a multi centric open trial in patients with Nazla (common cold). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at baseline and completion of the treatment. (i.e., 0 and 7th day). This includes subjective assessment of general well being and physical examination. The total duration of treatment will be 07 days. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy (i.e., 0 and 7th day).
Composition of Lauq-e-Nazli
|S. No.
Ingredients
Scientific/Botanical Name
Quantity
| --- | --- | --- | --- | |1.
Tukhm-e-Khatmi
Althaea officinalis Linn
25 gm
|2.
Behidana
Cydonia oblonga Mill.
25 gm
|3.
Asl-us-Soos
Glycyrrhiza glabra Linn
20 gm
|4.
Khaskhaash Safaid
Papaver somniferum Linn
20 gm
|5.
Qand Safaid
Sugar, API Crystals
500 gm
|6.
Khaskhaash Siyah
Papaver somniferum Linn
20 gm
|7.
Samagh-e-Arabi
Acacia nilotica Linn
10 gm
|8.
Maghz-e-Behidana
Cydonia oblonga Mill
10 gm
|9.
Kateera
Cochlospermum religiosum Linn.
15 gm
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
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of Nazla (Common Cold) presenting any of the following sign and symptoms: 1.Fever less than 100 F 2.Headache 3.Sneezing 4.Nasal irritation/ Nasal Itching 5.Redness of Face 6.Discharge of yellowish secretion of thin consistency 7.Sore throat/Khashunat e Halaq 8.Runny nose.
排除标准
- •Known cases of Acute or Chronic lower respiratory tract infection like pneumonia, Bronchitis, Asthma and Bronchiectasis.
- •Fever more than 100 o F.
- •History of hepatic, renal disorders, diabetes mellitus, hypertension, or any other ailment needing long term therapy.
- •Known cases of any other acute illness.
- •Pregnant and lactating women.
- •History of Addiction (smoking, alcohol).
结局指标
主要结局
The patients will be assessed by subjective and objective clinical observations which will be recorded in the follow-up sheet.
时间窗: At baseline and completion of the treatment. (i.e., 0 and 7th day)
次要结局
- Pathological and biochemical investigations for safety assessment i.e., Hemogram, LFT, KFT and Urine routine microscopy.(At baseline and completion of the treatment. (i.e., 0 and 7th day))
研究者
Dr N Zaheer Ahmed
Central Council for Research in Unani Medicine (CCRUM)