Clinical validation of Unani pharmacopoeial formulation Laooq Zeequnnafas Balghami in Zeeq un Nafas (Bronchial asthma)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Improvement in sign and symptoms of Zeeq un Nafas (Bronchial asthma) on the basis of Asthma Control Questionnaire (ACQ), Pulmonary Function Test:FEV1, FEV1/FVC ratio, PEFR by Spirometry,Absolute Eosinophil Count(AEC)
研究概览
简要总结
This study is designed as a single centric open trial in patients with Z**eeq un Nafas (Bronchial asthma)****.**After screening, Patients will be enrolled if they satisfy inclusion and exclusion criteria. The patients will be assessed clinically at every week for 4 weeks for improvement in patients with Bronchial Asthma. This includes subjective assessment of general well being and physical examination . The total duration of treatment will be 4 weeks. Laboratory parameters for safety assessment will be conducted at baseline and on completion of the protocol therapy.
Composition of Lauqe Zeequn Nafas Balghami
| S. No. |
Ingredients
Botanical / Chemical Name
Quantity
|
Asl- us - soos
Glycyrrhiza glabra Linn.
15 g.
|
Irsa (sausan)
Iris ensata Thunb.
15 g.
|
Gule Gaozaban
Onosma bracteatum Wall.
15 g.
|
Badiyan
Illicium verum. Hook
15 g.
|
Zufa E Kushk
Hyssopus officinalis
15 g.
|
Gul-e- Banafsha
Viola odorata**Linn.
15 g.
|
Unnab
Ziziphus sativa Gaertn
25 g.
|
Anjeer Zard
Ficus carica Linn.
25 g.
|
Maveez Munaqqa
Vitis vinifera L.
30g.
|
Tukhme Khatmi
Althea officinalis Linn
20 g.
|
Khubbazi
Malva sylvestris
20 g.
|
Parsiaoshan
Adiantum capillus-veneris
20 g.
|
Nabat Safed
Sugar crystal
1 kg
|
Asal
Shorea robusta
70 g.
|
Samaghe Arabi
Acacia arabica (lam.)
5 g.
|
Rubus Soos
Glycyrrhiza glabra Linn.
5 g.
|
Maghz e Chilghoza
Pinus gerardiana
5 g.
|
Mastagi
Pistacia lentiscus Linn
5 g.
|
Darchini
Cinnamomum verum
5 g.
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
- •Subjects of either sex between the age group of 18-65 years.
- •Subjects of Bronchial Asthma for at least 6 months presenting with at least one of the following symptoms: Wheeze Shortness of breath Chest tightness and cough that vary over time and in intensity, Expiratory airflow limitation as suggested by a decreased FEV1
- •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.
- •Subjects with Asthma Control Questionnaire Score > 1.5.
排除标准
- •FEV1/FVC ratio < 50%
- •Pregnant and lactating females
- •Subjects with other Respiratory Tract Infections, tuberculosis and malignancy.
- •Subjects with co-morbidities; Diabetes Mellitus, Hepatic and Renal Insufficiency
- •Subjects with known interstitial lung disease.
- •Subjects with Tobacco Smoking.
- •Subjects with known chronic obstructive pulmonary disease (COPD)
- •Patient with regular use of oral or systemic corticosteroids for conditions other than Asthma.
- •Subjects who are not willing to participate in the study.
结局指标
主要结局
Improvement in sign and symptoms of Zeeq un Nafas (Bronchial asthma) on the basis of Asthma Control Questionnaire (ACQ), Pulmonary Function Test:FEV1, FEV1/FVC ratio, PEFR by Spirometry,Absolute Eosinophil Count(AEC)
时间窗: At week 1, 2, 3 and 4
次要结局
- Haematological and biochemical assessment for safety assessment(At baseline and after 4 weeks)