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CTRI Number  CTRI/2025/09/094082 [Registered on: 02/09/2025] Trial Registered Prospectively
Last Modified On: 02/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Single Arm Study 
Public Title of Study   Effect of Drakshadi Churna in Tamaka Shwasa 
Scientific Title of Study   To Evaluate The Efficacy Of Drakshadi Churna In Childhood Tamaka Shwasa 
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 Reena Dixit 
Designation  Professor 
Affiliation  Rishikul Campus , Haridwar 
Address  Department Of Kaumarbhritya, OPD No. 10 Rishikul Campus, Devpura, Haridwar, Uttarakhand, 249401
Department Of Kaumarbhritya, Rishikul Campus, Devpura, Haridwar, Uttarakhand, 249401
Hardwar
UTTARANCHAL
249401
India 
Phone  09456131155  
Fax    
Email  reenadixit1317@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Reena Dixit 
Designation  Professor 
Affiliation  Rishikul Campus , Haridwar 
Address  Department Of Kaumarbhritya, OPD No. 10 Rishikul Campus, Devpura, Haridwar, Uttarakhand, 249401
Shusruth bhavan,Floor 1,Department of Kaumarbhritya Rishikul Campus, Devpura, Haridwar, Uttarakhand, 249401
Hardwar
UTTARANCHAL
249401
India 
Phone  9456131155  
Fax    
Email  reenadixit1317@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Reena Dixit 
Designation  Professor 
Affiliation  Rishikul Campus , Haridwar 
Address  Department Of Kaumarbhritya, OPD No. 10 Rishikul Campus, Devpura, Haridwar, Uttarakhand, 249401
Department Of Kaumarbhritya, OPD No. 10 Rishikul Campus, Devpura, Haridwar, Uttarakhand, 249401
Hardwar
UTTARANCHAL
249401
India 
Phone  09456131155  
Fax    
Email  reenadixit1317@gmail.com  
 
Source of Monetary or Material Support  
Rishikul Campus,Uttarakhand Ayurveda University,Devpura,Haridwar,Uttarakhand,India,249401  
 
Primary Sponsor  
Name  Rishikul Campus  
Address  Rishikul Campus ,Uttarakhand Ayurveda University,Haridwar 
Type of Sponsor  Research institution and hospital 
 
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 
Megha Bhandari  Rishikul Campus   OPD No. 10 and IPD of Kaumarbhritya Department Rishikul Campus,Haridwar, Uttarakhand, 249401 Department Of Kaumarbhritya, OPD No. 10 Rishikul Campus, Devpura, Haridwar, Uttarakhand, 249401
Hardwar
UTTARANCHAL 		 8445002770

meghab1998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J452||Mild intermittent asthma. Ayurveda Condition: TAMAKASVASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Drakshadi Churna , Reference: Chakradatta Balrogadhikar, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 35 Days, anupAna/sahapAna: Yes(details: -Madhu&Ghrita), Additional Information: -NIL
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  11.00 Year(s)
Gender  Both 
Details  1.Intermittent to mild cases of Asthma according to Global Initiative for Asthma (GINA) guidelines 2024.
2.Children having classical features of Tamaka Shwasa. 
 
ExclusionCriteria 
Details  1.Age group below 5 years and above 11 years.
2.Severe asthma according to Global Initiative for Asthma (GINA) guidelines 2024.
3.Patients with known cases of HIV, TB, Hep-B & Frequent H/O hospitalization due to status asthmatics.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Clinical Evaluation of Drakshadi Churna in the management of Childhood Tamaka Shwasa
Subjectively all signs & symptoms are given with grading depending upon their severity. 		 7 days 
 
Secondary Outcome  
Outcome  TimePoints 
Clinical Evaluation of Drakshadi Churna in the management of Childhood Tamaka Shwasa
Subjectively all signs & symptoms are given with grading depending upon their severity. 		 Seven days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   06/10/2025 
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="6"
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

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

  3. Who will be able to view these files?
    Response - Anyone

  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 (Others) -  Thesis, research articles

  6. For how long will this data be available start date provided 15-10-2026 and end date provided 15-10-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Tamaka Shwasa is a ‘Swatantra Vyadhi’ i.e., an independent disease entity having its etiology, pathophysiology, and management.Aacharya Charaka identifies both Vata and Kapha Doshas as key factors to the pathophysiology of Tamaka Shwasa. However, Sushruta Samhita, Madhav Nidana, and Yogratanakara specify Tamaka Shwasa as the Kapha Pradhan Vyadhi. In the present era, the escalating prevalence of recurrent airway disorders is observed in the global population.
 The drug for this trial is Drakshadi Churna and the study aims to evaluate the efficacy of Drakshadi Churna in mild and intermittent cases of Tamaka shwasa.
The total duration of treatment is 35 days with assessment will be done at interval of 7 days. Patient will be registered OPD and IPD of P.G  department of Kaumarbhritya , Rishikul Campus ,UAU,Haridwar.
 
 
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