A clinical study to see the effect of some Ayurvedic formulations in the management of Bronchial Asthma

Phase 2

Recruiting

Brief Summary: This study is aiming in generating the evidence for the scientific validation of the clinical efficacy and safety of classical Ayurvedic formulations. A multi centric clinical trial has been initiated in Bronchial asthma at 3 peripheral Institutes of Central Council for Research in Ayurvedic Sciences as an activity under Annul Action plan. Ayurvedic medicines Kanakasava 20ml twice daily after food, Trivrit churna 3gm during bedtime will be given for 12 weeks in 210 patients of Bronchial Asthma. This study will be conducted in 3 centres in India and completed in 2 years duration. The primary out come measures will be Change in Asthma Control Questionnaire (ACQ) from the baseline, at the end of 4th week, 8th week & 12th week. PEFR assessments of Personal best peak flow every 15days to the end of the trial. Secondary outcome measures will be change in St. Georgeâ€™s Respiratory Questionnaire(SGRQ-C) from the baseline, at the end of 4th week,8th week & 12th week.

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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.
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.

Primary Outcome Measures

Name	Time	Method
Primary Outcome Measure	12 weeks
â€¢Change in Asthma Control Questionnaire (ACQ) from the baseline, at the end of 4th week, 8th week & 12th week.	12 weeks
â€¢PEFR assessments of personal best peak flow every 15 days to the end of the trial	12 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome Measures	â€¢Change in St Georgeâ€Ÿs Respiratory Questionnaire (SGRQ-C) from the baseline, at the end of 4th week, 8th week & 12th week

Locations (3): M.S.Ayurveda Central Research Institute
🇮🇳
Jaipur, RAJASTHAN, India
National Ayurveda Dietetics Research Institute
🇮🇳
Bangalore, KARNATAKA, India
National Ayurveda Research Institute for Vector Borne Diseases
🇮🇳
Krishna, ANDHRA PRADESH, India
M.S.Ayurveda Central Research Institute
🇮🇳Jaipur, RAJASTHAN, India
DR ANU BHATNAGAR
Principal investigator
09261606061
anubhatnagar@ymail.com