A clinical study to see the effect of an Ayurvedic formulation in the patients of Bronchial Asthma

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 (Tamaka Swasa) (as per WHO GINA Guideline) 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

Primary Outcome Measures

Name	Time	Method
â?¢Change in the clinical symptoms (Asthma Control Questionnaire).Timepoint: Baseline, At the end of 14th day, 28th day, 42nd day, 56th day, 70th day, 84th day and at the end of follow up period of 4 weeks.

Secondary Outcome Measures

Name	Time	Method
â?¢Change in St Georgeâ??s Respiratory Questionnaire (SGRQ-C).Timepoint: Baseline, at the end of 84th day and at the end of follow up period of 4 weeks;â?¢Change in the objective parameters of PEFR & FEV1.Timepoint: Baseline, At the end of 14th day, 28th day, 42nd day, 56th day, 70th day, 84th day and at the end of follow up period of 4 weeks.