A clinical trial to study the effect of a drug agastya haritaki in post COVID19 and non COVID 19 patients of tamaka shwas (Bronchial asthma)
- Conditions
- Health Condition 1: J452- Mild intermittent asthma
- Registration Number
- CTRI/2024/04/065740
- Lead Sponsor
- Institute of Eminence
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Patient with stable Bronchial Asthma (Tamaka shwasa) (as per WHO GINA Guideline) for at least 6 weeks prior to study entry.
2. 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.
1. Patients with PEFR less than 50% and/ or FEV1 more than 50% of the predicted value.
2. Patients with evidence of malignancy.
3. Patients present with co-morbid disorders. (DM, TB, RA, Ca etc.).
Patient with poorly controlled Diabetes Mellitus (HbA1c more than10%).
4. Patients with poorly controlled Hypertension (i.e. Systolic more than 160 mm of Hg and Diastolic more than 100 mm of Hg)
5. 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.
6. Patients suffering from major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders, etc.)
7. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia .
8. Symptomatic patients with clinical evidence of Heart failure.
9. 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.
10. H/o hypersensitivity to the trial drug or any of its ingredients.
11. Pregnancy or lactating women.
12. Positive SARS-CoV-2 Real Time PCR or antigen in nasopharyngeal swab at screening visit.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the clinical symptoms (Asthma Control Questionnaire).Timepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method Change in the objectives/ laboratory parameters.Timepoint: 12 weeks