A clinical study to see the effect of some Ayurvedic formulations in the management of Bronchial Asthma
- Conditions
- Health Condition 1: null- Bronchial Asthma
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 210
1.Patients of either sex with age between 18 to 60 years.
2.Patients with stable Bronchial Asthma (Tamaka Swasa) (as per GINA Guideline) for at least 6 weeks prior to study entry.
3.Subjects with intermittent & mild persistent controlled bronchial asthma & show >12 % improvement in FEV1 after bronchodilator.
4.FEV1 of > 80% of predicted value.
5.Patients willing to participate and written consent.
1.Patients with FEV1 < 80% of the predicted value.
2.Patients with evidence of malignancy.
3.Patients with uncontrolled Diabetes Mellitus of HbA1c >7.5%.
4.Patients with unstable cardio vascular disease.
5.Patients with uncontrolled hypertension
6.Patients who needs rescue medication daily e.g. Salbutamol inhaler.
7.Patients suffering from other major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders, etc.)
8.Patients with concurrent serious hepatic disorder or Renal Disorders
9.Pulmonary disease other than bronchial asthma.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Outcome Measure <br/ ><br>â?¢Change in Asthma Control Questionnaire (ACQ) from the baseline, at the end of 4th week, 8th week & 12th week. <br/ ><br>â?¢PEFR assessments of personal best peak flow every 15 days to the end of the trialTimepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method Secondary Outcome Measures <br/ ><br>â?¢Change in St Georgeâ??s Respiratory Questionnaire (SGRQ-C) from the baseline, at the end of 4th week, 8th week & 12th weekTimepoint: 12 weeks