Clinical Validation of Unani Pharmacopoeial formulation Laooq-e-Unsul for symptomatic relief in patients of Sual-e-Muzmin (Chronic Cough)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- The efficacy of the study drugs will be assessed on the basis of Cough Severity Index
研究概览
简要总结
This study is designed as a multi centric open trial in patients with Sual-e-Muzmin (Chronic Cough). After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at 1st, 2nd and 3rd week for 4weeks. This includes subjective assessment of general well being and physical examination. The total duration of treatment will be 4weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
Composition ofLaooq-e-Unsul:
| S.No. |
Name of the Ingredient
Botanical/ English name
Quantity
|
Unsul Biryan
Urginea indica (Roxb.) Kunth
10 g
|
Beikh-e-Irsa
Iris ensata Thunb.
35 g
|
Farasiyun/tagar
Valeriana jatamansi
5 g
|
Zufa Khushk
Hyssopus officinalis Linn.
5 g
|
Qand-e-Safaid
Saccharum officianale
Q.S.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either sex in the age group of 18-60
- •Sual-e-Muzmin (Chronic cough) of more than 8 weeks duration.
排除标准
- •Acute Upper Respiratory Tract Infections (URI or URTI)
- •Acute Lower Respiratory Tract Infections (LRI or LRTI) including pneumonia, lung abscess, and acute bronchitis.
- •Chronic obstructive airway disease (COAD) including chronic bronchitis and emphysema.
- •History of Bronchiectasis, pulmonary tuberculosis, pulmonary edema, interstitial pulmonary fibrosis
- •Known cases of Tumors of larynx, bronchi, and lungs
- •Drug history of ACE Inhibitors
- •Known cases of Diabetes Mellitus, Hypertension
- •Known cases of severe hepatic, renal or cardiac ailments
- •H/o addiction (smoking, alcohol, drugs)
- •Pregnant and lactating women.
结局指标
主要结局
The efficacy of the study drugs will be assessed on the basis of Cough Severity Index
时间窗: At 1st, 2nd and 3rd week
次要结局
- Haematological & biochemical assessment for safety assessment i.e. CBC, LFT, KFT, Urine Routine & microscopic examination(At baseline and at the end of treatment for 4 weeks)