A study to compare action of Dashamoolakatutreyam Kashaya Granules and Simhyadi Kashaya Granules in the management of Tamaka Shwasa (Bronchial Asthma)

Phase 3

• Conditions: Health Condition 1: J452- Mild intermittent asthmaHealth Condition 2: J453- Mild persistent asthmaHealth Condition 3: J454- Moderate persistent asthma

• Registration Number: CTRI/2022/07/044108
• Lead Sponsor: Parul Institute of Ayurved

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1) Patients of age group 18 to 60 years irrespective of gender, occupation, and socio-economic status will be selected for the study.

2) Patients who are conscious and well oriented.

3) Patients in Avegakala Avastha.

4) Patient presenting with Pratyatma Lakshanas of Tamaka Shwasa.

5) Patient presenting with Clinical Features of Bronchial Asthma.

6) FEV1 or PEF 60-80% and = 80% predicted (GINA Guidelines)

Exclusion Criteria

1) Immunocompromised patients,

2) patients with acute exacerbation of Bronchial Asthma,

3) Acute Infections of Respiratory System requiring other treatments,

4) Patients of tuberculosis.

5) Uncontrolled Diabetes Mellitus,

6) patients who are on immunosuppression treatment for any other disease.

7) History of Cardio-vascular Diseases,

8) Uncontrolled Hypertension.

9) Pregnant woman and lactating mother.

10) FEV1 or PEF = 60% (GINA Guidelines)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Marked changes in PEFR and FEV1 (as assessed by Spirometry)Timepoint: Day – 1, Day- 15,Day- 30,Day- 45,Day- 60,Day- 75,Day- 90

Secondary Outcome Measures

Name	Time	Method
Gurguruka (wheezing), Swasa- Khichrata (dyspnea), Kasa (cough), Ura-Parshva Pidana (chest tightness), Nidra (sleep disturbances) <br/ ><br>Timepoint: Day – 1, Day- 15, Day- 30,Day- 45,Day- 60,Day- 75,Day- 90;Reduction in Days with wheeze <br/ ><br>marked changes will be noted in Days of slowed down or discontinued physical activities due to asthma <br/ ><br>Nights awaken due to asthma <br/ ><br>Unscheduled hospital visit due to asthma <br/ ><br>reduction in Number of asthma exacerbations.Timepoint: Day – 1, Day- 15,Day- 30,Day- 45,Day- 60,Day- 75,Day- 90