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CTRI Number  CTRI/2025/05/086102 [Registered on: 01/05/2025] Trial Registered Prospectively
Last Modified On: 30/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Efficacy of Dashamoola Rasayana in mild to moderate stable Chronic Obstructive Pulmonary Disease against Conventional Modern Medications - A Comparative Randamised Clinical Trial. 
Scientific Title of Study   Efficacy of Dashamoola Rasayana in mild to moderate stable Chronic Obstructive Pulmonary Disease against Conventional Modern Medications - A Comparative Randamised Clinical Trial. 
Trial Acronym  RACE 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Raghavendra Y 
Designation  BAMS, MD 
Affiliation  Glocal Ayurveda University,  
Address  #143, Ganga, Shakti Nagar, Gokul road, Hubballi
Mirzapur Pole, Sharnapur, Uttarpradesh-247121
Belgaum
KARNATAKA
580030
India 
Phone  8762885599  
Fax    
Email  raghu.y001@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Raghavendra Y 
Designation  BAMS, MD 
Affiliation  Glocal Ayurveda University,  
Address  #143, Ganga, Shakti Nagar, Gokul road, Hubballi
Mirzapur Pole, Sharnapur, Uttarpradesh-247121
Belgaum
KARNATAKA
580030
India 
Phone  8762885599  
Fax    
Email  raghu.y001@gmail.com  
 
Details of Contact Person
Public Query  
Name  Raghavendra Y 
Designation  BAMS, MD 
Affiliation  Glocal Ayurveda University,  
Address  #143, Ganga, Shakti Nagar, Gokul road, Hubballi
Mirzapur Pole, Sharnapur, Uttarpradesh-247121
Belgaum
KARNATAKA
580030
India 
Phone  8762885599  
Fax    
Email  raghu.y001@gmail.com  
 
Source of Monetary or Material Support  
nil 
 
Primary Sponsor  
Name  GLOCAL UNIVERSITY 
Address  Mirzapur Pole, Sharnapur, Uttarpradesh-247121 
Type of Sponsor  Other [AYURVEDA MEDICAL COLLEGE AND UNIVERSITY] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashok Gudagunti  Hubli Asthama Allergy And Chest Clinic  Court Circle Hubballi
Dharwad
KARNATAKA 		 9945551101

drashok1910@gmail.com 
Raghavendra Y  Vishwachetana Yoga And Research centre   No.3A Ward No:52 RN Shetty Road, Mukund Nagar, Hubballi - 580024
Dharwad
KARNATAKA 		 9035900980

vishwachetanayoga@Gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee, Glocal University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J449||Chronic obstructive pulmonary disease, unspecified. Ayurveda Condition: TAMAKASVASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Conventional Modern Medications Conventional Modern Medications (Inhaled Bronchodilators/Antimuscarinic/ β Adregenic Agonist and Inhaled Corticosteroids)
2Intervention ArmDrugClassical(1) Medicine Name: Dashamoola Rasayana, Reference: Asthanga Hridaya, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 3(g), Frequency: qid, Bhaishajya Kal: Muhurmuhu, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  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 ) 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
The primary outcome, as mentioned, is often the annual decline in lung function (FEV1), which indicates the progression of airflow obstruction  1 year 
 
Secondary Outcome  
Outcome  TimePoints 
Exacerbation Rates:
The frequency of COPD flare-ups, which are periods of worsening symptoms requiring treatment.
Respiratory Symptoms:
Changes in symptoms like shortness of breath, cough, and wheezing.  		 2 to 3 months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   19/05/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [raghu.y001@gmail.com].

  6. For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

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


 
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