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

Phase 2

• 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)

• Registration Number: CTRI/2017/08/009367
• Lead Sponsor: Central Council for Research in Ayurvedic Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 300

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

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 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Asthma Control Questionnaire (ACQ) from the baseline and at the end of 12th week. <br/ ><br>PEFR assessments of personal best peak flow every 14 days to the end of the trial. <br/ ><br>Timepoint: Change in Asthma Control Questionnaire (ACQ) from the baseline and at the end of 12th week. <br/ ><br>PEFR assessments of personal best peak flow every 14 days to the end of the trial. <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
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