Clinical Validation of Unani Pharmacopoeial Formulation Laooq-e- Zeequn Nafas in Zeequn Nafas (Bronchial Asthma)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Improvement in signs and symptoms of Zeequn Nafas (Bronchial Asthma)
研究概览
简要总结
This study is designed as a multicentric open trial in patients with Zeequn Nafas (Bronchial Asthma)****. After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be treated with Unani pharmacopoeial formulation Laooq-e- Zeequn Nafas 5gm twice daily with lukewarm water for four weeks. The patients will be assessed at every week. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be four weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
Composition of Laooq-e- Zeequn Nafas
| S. No. |
Ingredients
Botanical / Chemical Name
Quantity
|
Tukhm-e-Katan
Linum usitatissimum (Seed)
60 gm.
|
Maghz Badam Shireen Muqashshar
Prunus amygdalus (Dehusk Kernel)
60 gm.
|
Maweez Munaqqa
Vitis vinifera
30 gm.
|
Kateera
Cochlospermum religiosum (Gum)
30 gm.
|
Asl-us-Soos
Glycyrrhiza glabra
30 gm.
|
Maghz-e-Chilghoza
Pinus gerardiana (Kernel)
30 gm.
|
Nishasta-e-Gandum
Triticum aestivum
30 gm.
|
Samagh-e-Arabi
Acacia arabica (Gum)
30 gm.
|
Tukhm-e-Hulba
T**rigonella foenum-graecum (Seed)
10 gm
|
Qand Safaid
Sugar
600 gm
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
- •1.Males and females of 18-65 years.
- •2.Patients of Bronchial Asthma for at least 6 months presenting with at least one of the following symptoms: a.Wheeze b.Shortness of breath c.Chest tightness and cough that vary over time and in intensity, d.Expiratory airflow limitation as suggested by a decreased FEV1 3.Objective evidence for reversible airway obstruction (≥12% and ≥200 mL change in FEV1 and/or a 25% and 60 L/min change in PEFR) either spontaneously or after treatment.
- •4.Patients with Asthma Control Questionnaire Score > 1.5.
排除标准
- •1.FEV1/FVC ratio < 50% 2.Pregnant and lactating mother 3.Patient with other Respiratory Tract Infections, tuberculosis and malignancy.
- •4.Patient of Presence of chronic cough with expectoration for 2-3 months in each of 2 successive years.
- •5.Patient with co-morbidities, Diabetes Mellitus, Hepatic and Renal Insufficiency.
- •6.Patients with Tobacco Smoking.
- •7.Patient with regular use of oral or systemic corticosteroids for conditions other than Asthma.
结局指标
主要结局
Improvement in signs and symptoms of Zeequn Nafas (Bronchial Asthma)
时间窗: 4 weeks
次要结局
- Haematological and biochemical assessment for safety assessment(Investigations will be done at baseline and end of treatment)