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Efficacy of Dashamoola Rasayana in mild to moderate stable Chronic Obstructive Pulmonary Disease against Conventional Modern Medications - A Comparative Randamised Clinical Trial.

Not yet recruiting
Conditions
Chronic obstructive pulmonary disease, unspecified. Ayurveda Condition: TAMAKASVASAH,
Registration Number
CTRI/2025/05/086102
Lead Sponsor
GLOCAL UNIVERSITY
Brief Summary

This randomized, single blind, multicenter trial aims tocompare the efficacy of Dashmool Rasayan 3 grams, four times daily for 30days with conventional modern medications (inhaled bronchodilators,antimuscarinics, bita adrenergic agonists, and inhaled corticosteroids  inpatients with mild to moderate COPD. The primary outcome is the annual declinein lung function FEV1 over one year, indicating the progression of airflowobstruction. Secondary outcomes include the frequency of COPD exacerbations flare-upsrequiring treatment assessed over 45 days, changes in respiratory symptomssuch as shortness of breath, cough, and wheezing evaluated at 30 days, andchanges in depression levels as measured by the Beck Depression Inventory BDI score at 4 weeks. In COPD patients, mean baseline BDI scores typically rangebetween 14 and 20, indicating mild to moderate depression.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
100
Inclusion Criteria
  • Subjects of Either Sex, age between 16yr-70yr Informed consult provided Subjects Selection of the patients will done on the basis of three criteria viz.
  • Selection of the patients will done on the basis of three criteria viz.
  • Symptomatological criteria, Radiological and Spirometric criteria (given by GOLD 202431 ).
Exclusion Criteria
  • Severe COPD31(GOLD stage III and IV).
  • GOLD ABE category E31 patients Patients suffering from major systemic illness necessitating long term drug treatment and patients with clinical evidence of heart failure.
  • Patients suffering from other pulmonary diseases like pneumonia, cystic fibrosis, tuberculosis, lung cancer etc Patient suffering from Diabetes mellitus Patient Suffering from Chronic Kidney Diseases.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The primary outcome, as mentioned, is often the annual decline in lung function (FEV1), which indicates the progression of airflow obstruction1 year
Secondary Outcome Measures
NameTimeMethod
Exacerbation Rates:The frequency of COPD flare-ups, which are periods of worsening symptoms requiring treatment.

Trial Locations

Locations (2)

Hubli Asthama Allergy And Chest Clinic

🇮🇳

Dharwad, KARNATAKA, India

Vishwachetana Yoga And Research centre

🇮🇳

Dharwad, KARNATAKA, India

Hubli Asthama Allergy And Chest Clinic
🇮🇳Dharwad, KARNATAKA, India
Dr Ashok Gudagunti
Principal investigator
9945551101
drashok1910@gmail.com

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