Clinical Efficacy of Virechana Karma and Rasayana therapy in the management of Udavartajanya Santamaka Shwasa (Allergic bronchial asthma associated with functional constipation)-An exploratory single-arm clinical trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in FEV1, FEV1/FVC, FVC & PEFR.
研究概览
简要总结
Allergic Bronchial Asthma is a chronic inflammatory disorder with high prevalence, frequent relapses, and suboptimal control despite modern treatments. In Ayurveda, it aligns with Tamaka Shwasa, a Vata Kaphaja Yapya Vyadhi, where Udavarta, the vitiation of Vata causing pratiloma gati in the body, plays a key role in its pathogenesis and chronicity. While Udavarta has no direct parallel in modern medicine, functional constipation can be considered a clinical correlate, frequently observed but overlooked in asthma management. Emerging evidence on the gut lung axis supports this Ayurvedic perspective, highlighting the influence of gastrointestinal health on respiratory disorders. However, there is a significant research gap, as no clinical studies have explored the integrated management of Allergic Bronchial Asthma with functional constipation through Virechana Karma and Rasayana therapy. This study aims to address this unmet need.
RESEARCH QUESTION
Does Virechana Karma and Rasayana therapy improve clinical outcomes in patients of Udavartajanya Santamaka Shwasa (Allergic Bronchial Asthma associated with Functional Constipation)
HYPOTHESES
Null Hypothesis (H0)
Virechana Karma and Rasayana therapy has no efficacy in the management of Udavartajanya Santamaka Shwasa (Allergic Bronchial Asthma associated with Functional Constipation).
Alternate Hypothesis (H1)
Virechana Karma and Rasayana therapy has efficacy in the management of Udavartajanya Santamaka Shwasa (Allergic Bronchial Asthma associated with Functional Constipation).
Brief Methodology: Clinical trial involving single group of 40 participants. Patients visiting the OPD of AIIA will be screened based on specific proforma and those who are eligible will be admitted to the Kayachikitsa IPD of AIIA. Patients will be given Deepana Pachana with Musta and Shunthi Churna, Snehapana with Kantakari Ghrita, Virechana with Trivritadi Yoga, followed by Rasayana therapy with Amalaki Rasayana.
PRIMARY OBJECTIVE
To assess the changes in PFT parameters such as Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC), ratio between FEV1 and FVC, and Peak Expiratory Flow Rate (PEFR) after Virechana Karma and Rasayana therapy in patients of Udavartajanya Santamaka Shwasa (Allergic Bronchial Asthma associated with Functional Constipation).
SECONDARY OBJECTIVES
To assess the effect of Virechana Karma and Rasayana therapy on the frequency, severity, and recurrence of cardinal symptoms of Santamaka Shwasa.
To evaluate the improvement in lung functions using validated scoring tools viz. mMRC Dyspnoea Scale and Asthma Control Questionnaire (ACQ).
To evaluate the improvement in bowel habits and related symptoms using standardized scoring systems (Patients Assessment of Constipation Symptoms Questionnaire Score and Wexner Constipation Scoring System).
To evaluate the efficacy of Virechana Karma and Rasayana therapy in the management of allergy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 21.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of all genders between 21 and 60 years.
- •2.Patients having classical features of Santamaka shwasa as well as Udavarta.
- •A history of variable respiratory symptoms including wheeze, shortness of breath, chest tightness and cough.
- •3.Positive Reversibility Test: Evidence of reversible airway obstruction, as defined by an increase in FEV1 of greater than 200ml or greater than or equal to 12 percent of the pre-bronchodilator value between 20 to 30 minutes after 4 puffs (or less at the discretion of the investigator) of inhaled short-acting beta-agonist administration at Visit
- •4.FEV1/FVC ratio is less than 80 percent of predictive value.
- •Severity as Mild to Moderate stable asthma defined as FEV1 between 60 percent to 80 percent of the predicted value.
- •6.Patients presenting with functional constipation diagnosed as per ROME IV criteria.
- •7.Patients eligible for Virechana Karma.
排除标准
- •1.Evidence of active concomitant pulmonary diseases other than asthma like TB, pneumonia, etc.
- •2.Patients taking steroid therapy (systemic or inhaled).
- •3.Concomitant severe systemic disease (cardiovascular, renal, hepatic, endocrine, haematological, neurological, immunological).
- •4.Diagnosed cases of Hypothyroidism and Irritable bowel syndrome.
- •5.Patients with uncontrolled Type 2 Diabetes mellitus (HbA1c greater than 7 percent), Grade 2 Hypertension or more.
- •6.Past or current malignancy.
- •7.Pregnant ladies and lactating mothers.
- •8.History of any adverse drug reactions to any ingredient of the drug.
- •9.Patients having positive HIV1 and 2 or positive Hepatitis B.
- •10.Patients on medications such as antacids/iron supplements/laxatives/NSAIDS/Anti histamines/diuretics/anti psychotics.
- •11.Patients who participated in other clinical trials in past 12 weeks.
结局指标
主要结局
Change in FEV1, FEV1/FVC, FVC & PEFR.
时间窗: Assessment of signs and symptoms at baseline, after Virechana, after rasayana and after follow up of 1 month
次要结局
- Changes in the sign and symptoms of Santamaka Shwasa and udavarta.(Change in IgE level and AEC level.)
研究者
Dr Haritha T
All India Institute Of Ayurveda