A Single-Centric, Single-Arm Pilot Study to Evaluate the Safety and Efficacy of Swasa Kudori Chooranam (SKC) In the Management of Swasa Kaasam (Bronchial Asthma)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- 1. Effect of the trial drug will be assessed by Mean Improvement in Pulmonary Function Test, Asthma Control Test and MMRC Dyspnoea Scale from baseline.
研究概览
简要总结
In Siddha Medicine, the diseases that occurred in the respiratory system were classified as Kaasam, Irumal, Iraippu and Ilaippu etc. Swasa Kaasam is described as one of the twelve types of Kaasam characterized by paroxysmal dyspnoea, chest discomfort, emaciation and respiration associated with musical sounds can be correlated with the Bronchial Asthma in modern medicine. This study aims to determine the effect of Siddha formulation Swasa Kudori Chooranam (SKC) in Mild and Moderate Asthmatic populations. Swasa Kudori Chooranam (SKC) is a classical Siddha formulation that is prescribed for 96 types of respiratory disorders, including cold, cough and tuberculosis. The ingredients of SKC possess antiviral, anti-inflammatory, bronchodilator, and anti-nociceptive activities. The preclinical study in SKC also revealed that this drug have a significant Bronchodilation activity. The effect will be evaluated by the mean change in FEV1, FVC, Asthma Control Test, Modified Medical Research Council Dyspnea Scale and Asthma Quality of Life Questionnaire. Thus, the results of this trial will validate the safety and efficacy of Swasa Kudori Chooranam (SKC) on Swasa Kaasam (Bronchial Asthma) patients.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Symptoms of dry cough, recurrent attacks of dyspnoea, hoarseness of voice, tightness of chest, profuse sweating, and wheezing
- •Asthmatic attack due to seasonal changes and allergens
- •Willing to take radiological investigation and provide blood samples for lab investigation.
- •FEV1 with 50-80%.
排除标准
- •Asthma associated with COPD
- •Unstable bronchial asthma or status asthmaticus.
- •Asthma exacerbation during the past month.
- •COVID 19 Positive patients (on the time of recruitment).
- •Tuberculosis, Pneumonia, and Bronchogenic carcinoma
- •Cardiac, Liver and Renal Diseases.
- •Participation in another clinical trial within the preceding 90 days of the study starts.
- •Pregnant and lactating women.
- •Subjects with a continuing history of Alcohol, Smoking or Drug Abuse.
结局指标
主要结局
1. Effect of the trial drug will be assessed by Mean Improvement in Pulmonary Function Test, Asthma Control Test and MMRC Dyspnoea Scale from baseline.
时间窗: PFT, Asthma Control Test, MMRC Dyspnoea Scale and Asthma Quality of Life Questionnaire will be done on Day 0,16,31 and 121
2. Effect of the trial drug will be assessed by Mean Improvement in Quality of Life of trial participants assessed by Asthma Quality of Life Questionnaire with Standardized Activities from baseline.
时间窗: PFT, Asthma Control Test, MMRC Dyspnoea Scale and Asthma Quality of Life Questionnaire will be done on Day 0,16,31 and 121
次要结局
- 1. Safety of the study drug will be assessed by using following parameters: LFT, RFT, CRP and Urine routine on 0 day, 31st day and 121st day.(2. Effect of the trial drug will be assessed by Mean improvement in reducing the frequency of using allopathic drugs for acute asthmatic attacks.)
研究者
Dr S Shunmugaram
Siddha Regional Research Institute