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CTRI Number  CTRI/2024/05/066631 [Registered on: 01/05/2024] Trial Registered Prospectively
Last Modified On: 27/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Ayurvedic medicine for treating Tamak shwasa (Bronchial asthama)  
Scientific Title of Study   A single arm clinical study to evaluate the efficacy of an ayurvedic formulation in the management of tamak shwasa. (Bronchial Asthma). 
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 Harshit Kalkhundia 
Designation  MD Scholar Kayachikitsa 
Affiliation  Dr D Y Patil college of ayurveda and research centre 
Address  Kayachikitsa OPD No 5. Dr D Y Patil college of ayurveda and research centre, Sant tukaramnagar, Pimpri, Pune

Pune
MAHARASHTRA
411018
India 
Phone  7455070127  
Fax    
Email  harshitkalkhundia@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr D G Dipankar 
Designation  M.D. Ph.D. (Kayachikitsa) 
Affiliation  Dr D Y Patil college of ayurveda and research centre 
Address  Kayachikitsa OPD No 5. Dr D Y Patil college of ayurveda and research centre, Sant tukaramnagar, Pimpri, Pune

Pune
MAHARASHTRA
411018
India 
Phone  9822279321  
Fax    
Email  digambar.dipankar@dpu.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr D G Dipankar 
Designation  M.D. Ph.D. (Kayachikitsa) 
Affiliation  Dr D Y Patil college of ayurveda and research centre 
Address  Kayachikitsa OPD No 5. Dr D Y Patil college of ayurveda and research centre, Sant tukaramnagar, Pimpri, Pune

Pune
MAHARASHTRA
411018
India 
Phone  9822279321  
Fax    
Email  digambar.dipankar@dpu.edu.in  
 
Source of Monetary or Material Support  
Dr.D.Y.Patil College of Ayurveda and Research centre Sant tukaram nagar, Pimpri, Pune Pin code-411018 Maharashtra India. 
 
Primary Sponsor  
Name  Dr. Harshit Kalkhundia 
Address  Dr.D.Y.Patil College of Ayurveda and Research centre Sant tukaram nagar, Pimpri, Pune 
Type of Sponsor  Other [Self] 
 
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 Harshit Kalkhundia  Dr.D.Y.Patil College of Ayurveda and Research centre  Kayachikitsa OPD No 5. Dr.D.Y.Patil College of Ayurveda and Research centre Sant tukaram nagar, Pimpri, Pune 411018
Pune
MAHARASHTRA 		 7455070127

harshitkalkhundia@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DR. DYPCA & RC INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J453||Mild persistent asthma. Ayurveda Condition: TAMAKASVASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Vasa, Kantakari, Bharangi, Yastimaghu, Trikatu, Sameerpannag rasa, Yava kshara, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: -Luke warm water), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  The patient having a classical features of Tamak shwasa (Bronchial asthma) like Frequency of shwasa vega (Shortness of breath) Kasa (Cough), Pinasa (Coryza), Ghurghurukam(Wheezing) Asino labhyate soukhyam(Relieves discomfort insitting), Anidra (Disturbed sleep).
Age between 18 to 70 years.
History of Tamak shwasa less than 5 year
Peak flow meter rate more than 80lit/m and less than 300lit/m.
Class-All socio-economic classes.
 
 
ExclusionCriteria 
Details  Patients with a history of Tamak Shwasa (Bronchial Asthma) more than 5 yrs.
Asthma due to other systemic disorders, and Tuberculosis Lung cancer, Cystic Fibrosis,Pneumonia, Pleural effusion, and other respiratory disorder.
Asthma in pregnant women.
Patient in status asthmaticus.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in the symptoms of tamak shwasa(Bronchial Asthma) and improvement in the peak expiratory flow rate.  28 days with follow up on 14th , 28th day 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the improvement in peak expiratory flow rate, breath holding time, respiratory rate  28 days with follow up on 14th , 28th day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   22/05/2024 
Date of Study Completion (India) 01/09/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   To study the efficacy of an ayurvedic formulation in management of tamak shwasa (bronchial asthama). 
There are total 30 patients, ayurvedic formulation of 500 mg two tablets will be given with luke warm water before food in morning and evening, the study will be of 28 days and follow up on 14th and 28th day.
Peak expiratory flow rate, breath holding time, CBC with ESR, SpO2 saturation, LFT, RFT will be tested before and after and final conclusion will be drawn on the basis of statistical methods. 
 
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