An Open Clinical trial to Clinical Trial to evaluate the effectiveness of siddha formulation Thirikadugu Dravagam in the management of Swasakaasam (Bronchial Asthma) among patients reporting at 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 comparing the improvement in the clinical signs and symptoms by Asthma Control Test (ACT) before and after treatment.
研究概览
简要总结
BACKGROUND:
Siddhasystem of medicine is one of the traditional systems of medicine, originated fromthe South. According to the Siddha system, five elements exist in nature:earth,water, fire, air, and ether, all of which form the basis of all corporealthings. According to the theories of humoral pathology, all diseases are causedby the discordant mixture of vatham, pitham, and kabham. In the Siddha systemof medicine, Swasakaasam is correlated with bronchial asthma. Bronchial asthmais a common respiratory disorder. Annually, the World Health Organization (WHO)has estimated that 15 million disability-adjusted life-years are lost and250,000 asthma deaths are reported worldwide.
PRIMARYOBJECTIVE:
Toevaluate the clinical effectiveness of Siddha formulation THIRIKADUGUDRAVAGAM in the Management of SWASAKAASAM (BRONCHIAL ASTHMA) throughthe changes in clinical symptoms by using the Asthma Control Act (ACT) beforeand after treatment.
SECONDARYOBJECTIVE:
1.Toobserve the changes in clinical laboratory blood parameters such as IGE, AECand ESR before and after treatment.
2.To studythe changes in FEV1 values using the Pulmonary Function Test before and after treatment.
TREATMENT:
Internalmedicine : THIRIKADUGUDRAVAGAM
Dosage : (5 ML) twice a day
Adjuvant: Luke warm water
Durationof treatment : 48days
PRIMARYOUTCOME:
PrimaryOutcome is assessed by comparing the improvement in the clinical signs andsymptoms by Asthma Control Test (ACT) before and after treatment.
SECONDARYOUTCOME:
Changes inlaboratory parameters of CBC, IgE, and Absolute Eosinophil Count (AEC) beforeand after treatment and improved lung volumes and capacities using Pulmonary FunctionTests before and after treatment.
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.Patients who are willing to undergo a Pulmonary function test (FEV1 between 50%.
- •80%) will be included. 2.Patients with any 2 or more of the following clinical symptoms will be included: H/O Wheezing minimum 2 episodes per week Cough with or without expectoration Dyspnea Tightness of chest 3.Patients who are willing to undergo radiological investigations and provide blood samples for lab investigations.
排除标准
- •K/H/O Restrictive Lung diseases K/H/O Tuberculosis K/H/O Emphysema K/H/O Pleural effusion K/H/O Pneumothorax K/H/O Cardiac diseases K/H/O Renal diseases.
结局指标
主要结局
Primary Outcome is assessed by comparing the improvement in the clinical signs and symptoms by Asthma Control Test (ACT) before and after treatment.
时间窗: 48 days
次要结局
- Changes in laboratory parameters of CBC, IgE, and Absolute Eosinophil Count (AEC) before and after treatment and improved lung volumes and capacities using Pulmonary Function Tests before and after treatment.(48 days)