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CTRI Number  CTRI/2026/03/105780 [Registered on: 10/03/2026] Trial Registered Prospectively
Last Modified On: 09/03/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Molecular efficacy evaluation of Agastya haritaki rasayana on chronic obstructive pulmonary disorder (COPD) 
Scientific Title of Study   Evaluation of Pharmacokinetics, clinical efficacy and Innate Immunity response of T-cells count and Cytokine (IFN gamma/IL-2) on oral administration of Agastya haritaki rasayana in chronic obstructive pulmonary disorder (COPD) 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
24AYU026  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr I B Kotturshetty  
Designation  Principal and HOD  
Affiliation  Rajiv Gandhi education society Ayurvedic medical college Hospital Ron. Gadag Abbhigeri road, Ron 
Address  Rajiv Gandhi education society Ayurvedic medical college Hospital Ron. Gadag Abbhigeri road, Ron
Abbhigeri Road Ron
Gadag
KARNATAKA
582209
India 
Phone  9448236038  
Fax    
Email  dribkotturshetty@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manjunath Ajanal 
Designation  Professor 
Affiliation  Rajiv Gandhi education society Ayurvedic medical college Hospital Ron. Gadag Abbhigeri road, Ron 
Address  Abbhigeri Road Ron

Gadag
KARNATAKA
582209
India 
Phone  9036616510  
Fax    
Email  manju.ajanal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Manjunath Ajanal 
Designation  Professor 
Affiliation  Rajiv Gandhi education society Ayurvedic medical college Hospital Ron. Gadag Abbhigeri road, Ron 
Address  Abbhigeri Road Ron


KARNATAKA
582209
India 
Phone  9036616510  
Fax    
Email  manju.ajanal@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  Rajiv Gnadhi University of Health Sciences  
Address  4T Block Jayanagar Bangalore 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr I B Kotturshetty  Rajiv Gandhi Education Societys Ayurvedic hospital Ron   Abbhigeri Road Ron
Gadag
KARNATAKA 		 9036616510

dribkotturshetty@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Research on Human Subjects (IEHS) Rajiv Gandhi Education Society’s Ayurveda Medical College, Hospital and PG Research Center Ron-Karnataka: 582 209.  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: SVASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Agasthya haritaki rasayana, Reference: Ayurveda, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: Jala), Additional Information: -
2Comparator Arm (Non Ayurveda)-DoxyphyllinBronchodilator
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  30-50 years age group of either sex with confirmed diagnosis of moderate to very severe COPD without any co morbidities. 
 
ExclusionCriteria 
Details  Pregnant and lactating women Dementia, mental disorders, and reluctant partner, diabetis, Hypertension, Complicated with heart failure, Current respiratory disorders other than COPD  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Dyspnea,
Cough,
Expectoration,
Wheezing,
Frequency of attack and
Peak expiratory flow rate,
Forced vital capacity,
Forced expiratory volum 		 45 days 
 
Secondary Outcome  
Outcome  TimePoints 
total leukocyte count, differential count of neutrophils, leukocytes, eosinophils etc, ESR, Hb%, total RBC and Absolute Eosinophil Count (AEC) conducted before and after treatment are also considered while assessing the clinical efficacy along with changes in T cell count, IFNs gamma/IL-2 assay  45 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   Phase 2 
Date of First Enrollment (India)   04/05/2026 
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 - NO
Brief Summary  
Chronic Obstructive Pulmonary Disease (COPD) is a progressive inflammatory airway disorder associated with repeated exacerbations and high morbidity. Conventional treatments mainly provide symptomatic relief and limited immune modulation. Agastya Haritaki Rasayana (AHR), a classical Ayurvedic formulation indicated in respiratory disorders, is traditionally used for Kasa and Shwasa but lacks scientific validation regarding its pharmacokinetics and molecular immune effects.

 
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