A clinical study to see the effect of an Ayurvedic formulation in the patients suffering from Breathlessness.

Phase 2

• Conditions: Health Condition 1: null- Bronchial Asthma

• Registration Number: CTRI/2012/04/002584
• Lead Sponsor: Central Council for Research in Ayurvedic Sciences CCRAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

1. Patients of either sex with age between 18 to 60 years.

2. Patient with stable Bronchial Asthma for at least 6 weeks prior to study entry.

3. 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.

4. Patient willing and able to participate for 16 weeks.

Exclusion Criteria

1. Patients with PEFR < 50% and/ or FEV1 < 50% of the predicted value.

2. Patients with evidence of malignancy.

3. Patient with poorly controlled Diabetes Mellitus (HbA1c > 10%).

4. Patients with poorly controlled Hypertension (i.e. Systolic > 160 mm of Hg and Diastolic >= 100 mm of Hg)

5. Patients on prolonged ( >= 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 in the last 6 months.

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) > 2 times upper normal limit) or Renal Disorders (defined as S. Creatinine > 1.2mg/dL), Severe Pulmonary Dysfunction, or any other condition that may jeopardize the study.

10. Smoker/alcoholics and/or drug abusers.

11. H/o hypersensitivity to the trial drug or any of its ingredients.

12. Patients who have completed participation in any other clinical trial during the past six (06) months.

13. Pregnancy or lactating women.

14. Any other condition which the Principal Investigator thinks may jeopardize the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified