Study of a Ayurveda medicine named AYUSH A in the treatment of Mild Bronchial Asthma (Tamak Shwas)

MULTICENTRIC PLACEBO CONTROLLED CLINICAL STUDY OF AYURVEDIC CODED DRUG â??AYUSH â??Aâ?? IN THE MANAGEMENT OF MILD BRONCHIAL ASTHMA (TAMAKA SHWASA)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/08/009367

Enrollment

300

Registered

2017-08-14

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- MULTICENTRIC PLACEBO CONTROLLED CLINICAL STUDY OF AYURVEDIC CODED DRUG â??AYUSH â??Aâ?? IN THE MANAGEMENT OF MILD BRONCHIAL ASTHMA (TAMAKA SHWASA)

Interventions

Intervention1: AYUSH-A: Ayush_A 2gm TDS for 84 days Control Intervention1: Placebo: Matching Placebo of Ayurvedic Treatment

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.Patients with mild bronchial asthma & show > 12 % or 200 ml improvement in FEV1 after 2 puffs of beta - 2 agonist inhalation. 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 who needs rescue medication daily e.g. Salbutamol inhaler. 6.Patients suffering from other major systemic illness necessitating long term drug treatment (Rheumatoid arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders, etc.) 7.Patients with concurrent serious hepatic disorder or Renal Disorders 8.Pulmonary disease other than bronchial asthma. 9.Smoker/alcoholics and/or drug abusers. 10.H/o hypersensitivity to the trial drug or any of its ingredients. 11.Patients who have completed participation in any other clinical trial during the past six (06) months. 12.Pregnancy or lactating women.

Design outcomes

Primary

Measure	Time frame
Change in Asthma Control Questionnaire (ACQ) from the baseline and at the end of 12th week. PEFR assessments of personal best peak flow every 14 days to the end of the trial. Timepoint: Change in Asthma Control Questionnaire (ACQ) from the baseline and at the end of 12th week. PEFR assessments of personal best peak flow every 14 days to the end of the trial.	—

Secondary

Measure	Time frame
Change in St Georgeâ??s Respiratory Questionnaire (SGRQ-C) from the baseline and at the end of 12th week.Timepoint: baseline and at the end of 12th week	—

Countries

India

Contacts

Public ContactDr S K Sharma

CCRAS

drdssahu@gmail.com8895173999

Outcome results

None listed

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