Randomized Controlled Clinical Study to Evaluate the Efficacy of Nidigdhikadi Yoga and Shatyadi Churna in the Management of Tamaka Shwasa with Special Reference to Bronchial Asthma.
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- Institute for Ayurved Studies & Research Shri Krishna AYUSH University
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- 1.Improvement in lung function: Measure changes in FEV1 (Forced Expiratory Volume in 1second),FVC,FVR or PEFR (Peak Expiratory Flow Rate).
概览
简要总结
This randomized, open-label, parallel-group clinical trial will assess and compare the efficacy of two classical Ayurvedic formulations, Nidigdhikadi Yoga and Shatyadi Churna, in the management of Tamaka Shwasa (Bronchial Asthma). Sixty-six eligible participants will be randomly assigned into two groups. Group A will receive Nidigdhikadi Yoga 5 g twice daily before meals with honey, and Group B will receive Shatyadi Churna 5 g twice daily before meals with honey, for 21 days, followed by post-treatment follow-up until Day 42. Outcome evaluation will be performed using standardized subjective symptom scoring, spirometry parameters (FEV1, FVC, FEV1/FVC ratio, and PEFR), and inflammatory indices including absolute eosinophil count, ESR, and CRP. All participants will be advised appropriate pathya–apathya (dietary and lifestyle regimen) during the study. Institutional Ethics Committee (IEC) approval has been obtained and written informed consent will be taken prior to enrolment. The primary objective is to determine comparative improvement in asthma severity, respiratory function, and clinical response between the two interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient willing for clinical trial and ready to give written Consent.
- •Patients between the age group of 30-60 years of either sex.
- •Patients fulfill the diagnostic criteria of Tamaka Shwasa (Bronchial Asthma).
- •Patients presented with cardinal features of Tamaka Shwasa as described in Ayurveda texts.
- •Newly Diagnosed and confirmed cases of Tamaka Shawasa (Bronchial Asthma) on the basis of criteria given by NAEPP.
- •Patient not willing to Clinical Trial
- •Patients not fulfilling the Inclusion Criteria
- •Patient having an Age below 30 and Above
- •Patients having a medical history of CHF, CAD, Pulmonary hypertension, Diabetes Mellitus, Uncontrolled hypertension, CKD, and Autoimmune disorders.
- •During Pregnancy, Lactation period.
排除标准
- •Patient not willing to Clinical Trial
- •Patients not fulfilling the Inclusion Criteria
- •Patient having an Age below 30 and Above
- •Patients having a medical history of CHF, CAD, Pulmonary hypertension, Diabetes Mellitus, Uncontrolled hypertension, CKD, and Autoimmune disorders.
- •During Pregnancy, Lactation period.
- •Patients on Steroid therapy, Inhaler or any other medicines.
- •Patient Suffering from Secondary Respiratory Disease.
结局指标
主要结局
1.Improvement in lung function: Measure changes in FEV1 (Forced Expiratory Volume in 1second),FVC,FVR or PEFR (Peak Expiratory Flow Rate).
时间窗: 21 Days
2. Change in intensity and severity of Rhonchi and Wheeze.
时间窗: 21 Days
3.Change in intensity and severity in the symptoms of Tamaka Shwasa.
时间窗: 21 Days
次要结局
- 1. To assess the effect of the interventions on biochemical markers such as absolute eosinophil count and inflammatory indices(ESR and CRP).(2. Exacerbation frequency: Track changes in frequency of asthma exacerbations.)
研究者
Dr Randhir
Institute For Ayurved Studies and Research Shri Krishna AYUSH University