An Open Labelled Comparative Clinical Study to Evaluate the Efficacy of Bharangyadi Madhuka and Talishadi Churna in the Management of Tamaka Shwas with special Reference to Bronchial Asthma
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Decrease in the sign and symptoms such as Frequency, episodes and intensity of attack, cough with sputum, chest pain, irritation in throat, rhinitis, thirst.
研究概览
简要总结
Asthma is a syndrome of variable airflow obstruction. It is a state of disordered immunity in which the predominant T helper lymphocyte Type -2 immune mechanism drives the production of IgE on exposure to common environment allergens. Globally, asthma is ranked 24th among the leading causes of years lived with disability and 34th among the leading causes of burden of disease, as measured by disability adjusted life years. So a study will be conducted aimed to evaluate the efficacy of Bharangyadi Madhuka in comparison to TalishadiChurna in the management of Tamaka Shwasa for which a total of 60 patients of either sex and age group (25-60 yr) will be selected randomly from OPD & IPD of Kayachikitsa Department and will be divided into two groups each having 30 patients. In group A Bharangyadi Madhuka 6g will be given with vishammatraofmadhusarpi twice after meal and in Group B TalishadiChurna 6g will be given with honey twice after meal for 21 days. Patients will be followed up at a regular interval of 7 days during the course of the trial and 3 post treatment follow ups will be done at regular interval of 7 days. Clinical features and laboratory investigations will be analysed during and after the treatment. Results will be analysed in accordance with the appropriate statistical tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 25.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Patient willing for clinical trial and ready to give written Consent.
- •2 Patient between the age group of 25-60 years of either sex.
- •3 Patients fulfill the diagnostic criteria of Tamaka Shwasa (Bronchial Asthma).
- •4 Patients presented with cardinal features of Tamaka Shwasa as described in Ayurveda texts.
- •5 Diagnosed and confirmed cases of Tamaka Shawasa (Bronchial Asthma) on the basis of criteria given by NAEPP having Mild Intermittent and Mild Persistent type of Asthma 1 Patient not willing to Clinical Trial 2 Patients not fulfilling the Inclusion Criteria.
- •3 Patient having an Age below 25 and Above
- •4 Patients having a medical history of CHF, CAD, Pulmonary hypertension, Diabetes Mellitus, Uncontrolled hypertension, CKD, and Autoimmune disorders.
- •5 During Pregnancy, Lactation period 6 Patients on Steroid therapy, Inhaler.
- •7 Patient Suffering from Secondary Respiratory Disease.
排除标准
- •1 Patient not willing to Clinical Trial 2 Patients not fulfilling the Inclusion Criteria.
- •3 Patient having an Age below 25 and Above
- •4 Patients having a medical history of CHF, CAD, Pulmonary hypertension, Diabetes Mellitus, Uncontrolled hypertension, CKD, and Autoimmune disorders.
- •5 During Pregnancy, Lactation period 6 Patients on Steroid therapy, Inhaler.
- •7 Patient Suffering from Secondary Respiratory Disease.
结局指标
主要结局
Decrease in the sign and symptoms such as Frequency, episodes and intensity of attack, cough with sputum, chest pain, irritation in throat, rhinitis, thirst.
时间窗: 21 days
次要结局
- Improvement in the levels of chest X ray, AEC, CRP, PFT.(Reduction in scoring pattern of assessment criteria.)
研究者
Dr Adbhut Kumar Mundhara
Institute For Ayurved Studies and Research