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CTRI Number  CTRI/2023/10/059177 [Registered on: 27/10/2023] Trial Registered Prospectively
Last Modified On: 26/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive
Other (Specify) [Curative and Preventive ]  
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A clinical trial comparing the effects of Kunjal kriya, Agastya Haritaki Rasayana and Nadi Shodhana pranayama on COPD (chronic obtructive pulmonary disease)(a kind of lung disease that cause airflow blockage and breathing problem) 
Scientific Title of Study   A prospective comparative clinical study of Agastya Haritaki Rasayana and Nadi Shodhana Pranayama along with Kunjal Kriya on COPD (Chronic obstructive pulmonary disease) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aakanksha sharma 
Designation  Ph.D. Scholar  
Affiliation  dsrrau jodhpur  
Address  Department of Swasthavritta and Yoga, PGIA, DSRRAU Jodhpur Rajasthan

Jodhpur
RAJASTHAN
342037
India 
Phone  9024197881  
Fax    
Email  vijayaakanksha11@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pramod Kumar Mishra 
Designation  Professor  
Affiliation  dsrrau jodhpur  
Address  department of swasthavritta and Yoga, PGIA, DSRRAU, Jodhpur, Rajasthan

Jodhpur
RAJASTHAN
342037
India 
Phone  9001009793  
Fax    
Email  drpramodmishra4@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pramod Kumar Mishra 
Designation  Professor  
Affiliation  dsrrau jodhpur  
Address  Department of Swasthavritta and Yoga, PGIA, DSRRAU, Jodhpur, Rajasthan

Jodhpur
RAJASTHAN
342037
India 
Phone  9001009793  
Fax    
Email  drpramodmishra4@gmail.com  
 
Source of Monetary or Material Support  
MJF Ayurvedic mahavidyalaya Harota Chomu Jaipur  
 
Primary Sponsor  
Name  Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Jodhpur  
Address  Dr Sarvepalli radhakrishnan Rajasthan ayurved University Karwar Jodhpur (Rajasthan) 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
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 Aakanksha Sharma   Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University Hospital Karwad, Jodhpur Rajasthan   Dr Sarvepalli Radhakrishnan Rajasthan Ayurveda University hospital Department of Swathavritta, Room No.08
Jodhpur
RAJASTHAN 		 9024197881

vijayaakanksha11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, Jodhpur Post Graduate Institute of Ayurved Institutional ethics committee   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 ArmLifestyle--Dinacarya: , Ritucarya: , Acara Rasayana:, Other:40 sets of Nadi Shodhana Pranayama, twice daily for 3 months, Pathya/Apathya:, Pathya:, Apathya:
2Intervention ArmDrugClassical(1) Medicine Name: Agastya Haritaki Rasayana, Reference: Charak Samhita Chikitsa Sthana, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: Ushnodaka), Additional Information: -
3Comparator ArmLifestyle--Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Kunjal Kriya once in a week for 3 months, Pathya/Apathya:, Pathya:, Apathya:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Adults of either sex 18-60 years of age (working age in India)
2. mild and moderate cases of COPD.
3 individuals having allergic asthma. 
 
ExclusionCriteria 
Details  1. individuals having any kind of severe respiratory disease or ailments.
2. Individuals with chronic heart diseases, kidney or liver diseases.
3. pregnant ladies, persons below 18 years and above 60 years of age.
4. Individuals with history of chronic asthma.
5. Individual having severe persistent asthma. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Relief in sign and symptoms  3 months  
 
Secondary Outcome  
Outcome  TimePoints 
Decrease chances of reoccurrence   3 months 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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 3 
Date of First Enrollment (India)   15/11/2023 
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="0"
Months="3"
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   This study is a randomized, parallel group, multiple arm trial comparing the efficacy of Agastya Haritaki Rasayana (10 grams with ushnodaka for 3 months), Nadi shodhana Pranayama (40 sets twice daily for 3 months) and Kunjal kriya (once in a week for 3 months) in 120 individuals having mild to moderate COPD that will be conducted in Jaipur (Rajasthan).   
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