An open Non-Randomized clinical trial to evaluate the effectiveness of Kadukkai Vadagam in the management of Swasakasam ( Bronchial Asthma) among patients attending Ayothidoss pandithar Hospital, National Institute of Siddha
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Primary outcome is assessed by the values of pulmonary function
研究概览
简要总结
BACKGROUND: SWASAKASAM is due to the derangement of kapham humor.The increased kapham either with vatham or pitham affects nostrils, throat ,respiratory pathways and lungs. This causes more inflammation leading to disturbances in inspiration and expiration. According to YUGI VAITHIYA CHINTHAMANI 800,Kasam can be classified as 12 types and swasakasam is one among them. The important causes of the diseases are exposure to cold foods, water and climate, inhalation of smoke, allergic items, intake of non vegetarian, starving on hunger ,stealing foods, uttering false talks etc,.This is an open clinical trial that evaluates the effectiveness of KADUKAI VADAGAM in the management of SWASAKASAM(Bronchial Asthma)
OBJECTIVE :
PRIMARY OBJECTIVE : 1.To evaluate the clinical effectiveness of KADUKKAI VADAGAM in the Management of SWASAKASAM (BRONCHIAL ASTHMA) by using pulmonary function test.
2.To observe the changes in clinical symptoms by asthma control questionnaire
3.The Standardization of the trail drug will be done as per PLIM guidelines.
SECONDARY OBJECTIVE : To observe the changes in clinical laboratory parameters such as IGE,AEC, before and after treatment
METHODOLOGY: A total of 30 diagnosed patients of Swasakasam( Bronchial Asthma) within the age limit of 18 to 60 years willing to participate in the study by signing the consent form will be enrolled in the study based on inclusion criteria. Known case of Diabetes mellitus (Uncontrollable), Cardiac disease, Renal disease, and Other lung diseases will be excluded.
OUTCOME:
PRIMARY OUTCOME: .Primary outcome is assessed mainly by the values of pulmonary function test, and improvement in the clinical signs and symptoms by Asthma control questionnaire pre and post treatment.
SECONDARY OUTCOME: Laboratory parameters such as IgE, Absolute Eosinophil Count (AEC) ,pre and post treatment.
RESULTS AND DISCUSSION : The result will be statistically analysed
KEYWORDS: Swasakasam, Bronchial Asthma, kadukai vadagam
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
- •1.Adults who are diagnosed with bronchial asthma are included in the study 2.Patients with a clinical symptoms of Swasakasam -Cough with or without expectoration,Recurrent episodes of Wheezes, Tightness of chest,Dyspnea.,Breathing difficulty.
- •(Any of 2 or more symptoms will be included) 3.Patient who are willing to take radiological investigation and provide blood sample for lab investigation.
- •4.Patient who are willing to undergo Pulmonary function test 5.FEV1 is 50% to 80%.
排除标准
- •1.Diabetes mellitus (Uncontrollable) 2.K/C/O Cardiac disease 3.K/C/O Renal disease 4.K/C/O Other lung diseases 5.Pregnancy 6.Lactation.
结局指标
主要结局
Primary outcome is assessed by the values of pulmonary function
时间窗: 8 WEEKS
test
时间窗: 8 WEEKS
次要结局
- 1.Improvement in the clinical signs & symptoms by Asthma control(questionnaire pre & post treatment)