A comparative clinical study on the efficacy of Agastya Haritaki in post COVID-19 & non COVID-19 subjects of Tamaka shwas (Bronchial asthma)
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in the clinical symptoms (Asthma Control Questionnaire).
研究概览
简要总结
Asthma is a chronic disease characterized by recurrent attacks of breathlessness and wheezing, which vary in severity and frequency from person to person. WHO estimates show that 300 million people currently suffer from asthma. Asthma deaths will increase in the next 10 years if urgent action is not taken.[ Bousquet J, Khaltaev N et.al] Asthma cannot be cured but proper diagnosis, treatment and patient education can result in good asthma control and management. For effective control, it is essential to make medications affordable and available, especially for low�’income families.
On the basis of similar clinical features, Bronchial Asthma can be correlated with Tamaka shwas, a disease described under the heading of five types of Shwasa in Ayurvedic classics. According to Ayurveda, Shwasa is a Kapha�’Vataja disease, which is originated from Pittasthana. According to Ayurveda, formation of Ama is the seed for the development of future disease. The acute attack of disease appears whenever there is an obstruction of the normal passage of Pranavayu. Once the obstruction is removed, and Vayu start travelling in its normal path symptom, (breathlessness, cough etc.,) are abolished. Considering the Ayurvedic concept of treatment of Tamaka shwas it was decided to select an herbal Preparation “Agastya Haritaki †for the management of bronchial asthma.
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient with stable Bronchial Asthma (Tamaka shwasa) (as per WHO GINA Guideline) for at least 6 weeks prior to study entry.
- •Positive test of reversibility: • Symptomatic patients.
- •an improvement of 60 L/min or ≥20% in PEFR, 10 minutes after the inhalation of 200 mcg of Salbutamol. • Asymptomatic patients.
- •60 L/min or ≥20% fall in PEFR by provocation with 5-10 minutes of physical exercise, followed by reversal upon inhalation of 200 mcg of Salbutamol, when assessed after 10 minutes. 3.Patient willing and able to participate for 16 weeks.
排除标准
- •Patients with PEFR less than 50% and/ or FEV1 more than 50% of the predicted value.
- •Patients with evidence of malignancy.
- •Patients present with co-morbid disorders.
- •(DM, TB, RA, Ca etc.).
- •Patient with poorly controlled Diabetes Mellitus (HbA1c more than10%).
- •Patients with poorly controlled Hypertension (i.e. Systolic more than 160 mm of Hg and Diastolic more than 100 mm of Hg)
- •Patients on prolonged ( more than 6 weeks) medication with corticosteroids, bronchodilators, mast cells stabilizers, antidepressants, anticholinergics, etc.
- •or any other drugs that may have an influence on the outcome of the study.
- •Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders, etc.)
- •Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia .
- •Symptomatic patients with clinical evidence of Heart failure.
- •Patients with concurrent serious hepatic disorder (defined as Aspartate Amino Transferase (AST) and / or Alanine Amino Transferase (ALT), Total Bilirubin, Alkaline Phosphatase (ALP) more than 2 times upper normal limit) or Renal Disorders (defined as S.
- •Creatinine more than1.2mg/dL), Severe Pulmonary Dysfunction, or any other condition that may jeopardize the study.
- •H/o hypersensitivity to the trial drug or any of its ingredients.
- •Pregnancy or lactating women.
- •Positive SARS-CoV-2 Real Time PCR or antigen in nasopharyngeal swab at screening visit.
结局指标
主要结局
Change in the clinical symptoms (Asthma Control Questionnaire).
时间窗: 12 weeks
次要结局
- Change in the objectives/ laboratory parameters.(12 weeks)
研究者
Shalini
Institute of medical sciences, BHU