CTRI/2024/04/065740Not yet recruitingPhase 2
A comparative clinical study on the efficacy of Agastya Haritaki in post COVID-19 & non COVID-19 subjects of Tamaka shwas (Bronchial asthma) - NI
Institute of Eminence0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Investigators
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