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

Clinical evaluation of Kanakasava and Trivrit Churna in the management of Bronchial Asthma (Tamaka Swasa) in the management of Bronchial Asthma (Tamaka Swasa)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/04/006801
Enrollment
210
Registered
2016-04-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Bronchial Asthma

Interventions

Intervention1: Kanakasava, Trivrit churna: 1.Kanakasava 20ml twice daily with luke warm water for 12 weeks. 2.Trivrit churna 3gm during bed time with luke warm water for 12 weeks. Control Intervention

Sponsors

Central Council for Research in Ayurvedic Sciences
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: 1.Patients with FEV1 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.

Design outcomes

Primary

MeasureTime frame
Primary Outcome Measure â?¢Change in Asthma Control Questionnaire (ACQ) from the baseline, at the end of 4th week, 8th week & 12th week. â?¢PEFR assessments of personal best peak flow every 15 days to the end of the trialTimepoint: 12 weeks

Secondary

MeasureTime frame
Secondary Outcome Measures 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

Countries

India

Contacts

Public ContactDr R Kumara Swamy

National Ayurveda Research Institute for Vector Borne Diseases(CCRAS)

drrkswami@yahoo.co.in8500064848

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026