A Clinical Evaluation of Siddha Herbal Formulation Thippili Nei in the management of Swasakaasam (Bronchial Asthma) among patients reporting at Out Patient Department of Ayothidoss Pandithar Hospital, National Institute of Siddha.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- 1.Outcome is assessed by comparing the lung volumes and capacities in pre and post treatment using Pulmonary function test reports
研究概览
简要总结
INTRODUCTION:
This is an open clinical trial thatevaluates therapeutic effectiveness of siddha formulation THIPPILI NEI in themanagement of SWASAKAASAM (BRONCHIAL ASTHMA) patients through improvement inlung volumes and capacities in pulmonary function test reports, IgE, ESR,Absolute Eosinophil Count (AEC) before and after treatment and changes in the AsthmaControl Questionnaire(ACQ). Asthma affects 5-10% of the population or anestimated 23.4 million persons, including 7 million children. Approximately 300million people worldwide currently have asthma and its prevalence increasesby 50% every decade. Annually, the World Health Organization (WHO) hasestimated that 15 million disability-adjusted life-years are lost and 250,000asthma deaths are reported worldwide. In Asia, increased prevalence is likelydramatic in India and china.
OBJECTIVE:
· Toassess the therapeutic effectiveness of Siddha formulation “THIPPILI NEIâ€in the management of “SWASAKAASAM†(BRONCHIAL ASTHMA) byusing Pulmonary function test (PFT), IgE, AEC and ESR
· To observe the changes in clinicalsymptoms by Asthma control Questionaire
MATERIALS AND METHODS:
A Total of 10 diagnosed patients of Swasakaasam (Bronchial Asthma) within the agelimit of 18 -60 years willing to participate in the study, by signing theconsent form will be enrolled in the study. Having covid -19 (or) recenthistory of covid -19 (within 3 weeks), Restrictive Lung diseases, Tuberculosis,Cardiac diseases and Renal diseases, Pregnancy will be excluded. Assessment isdone through improvement in Asthma Control Questionnaire(ACQ), lung volumes andcapacities in pulmonary function test reports, IgE, ESR, Absolute EosinophilCount (AEC) before and after treatment.
RESULTS AND DISCUSSION:
The result will be statisticallyanalyzed
KEYWORDS:
Swasakaasam, BronchialAsthma, Thippili nei.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Patients with clinical symptoms of Wheezing, Cough with or without expectoration, Dyspnea, tightness of chest H/O Wheezing minimum 2 episodes per week 2.Patients who are willing to undergo Pulmonary Function Test (FEV1- 50-80%) will be taken 3.Patients who are willing to undergo radiological investigation and provide blood sample for lab investigation.
排除标准
- •1.Having Covid 19 (or) recent history of covid 19 infection
- •Restrictive Lung diseases 3.Tuberculosis 4.Cardiac diseases
- •Renal diseases 6.
结局指标
主要结局
1.Outcome is assessed by comparing the lung volumes and capacities in pre and post treatment using Pulmonary function test reports
时间窗: 2 Month - SCREENING | 2 Months - PATIENT ENROLLEMENT | 2 Month - OUTCOME ASSESMENT
2. Changes in the clinical symptoms by Asthma Control Questionnaire (ACQ)
时间窗: 2 Month - SCREENING | 2 Months - PATIENT ENROLLEMENT | 2 Month - OUTCOME ASSESMENT
3.Changes in the labaratory parameters IgE, AEC, ESR before and after treatment
时间窗: 2 Month - SCREENING | 2 Months - PATIENT ENROLLEMENT | 2 Month - OUTCOME ASSESMENT
次要结局
未报告次要终点