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CTRI Number  CTRI/2023/08/056084 [Registered on: 03/08/2023] Trial Registered Prospectively
Last Modified On: 02/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Ayurveda Management Of Acute Excerbation Of Tamaka Shwasa(Bronchial Asthma) in Children 
Scientific Title of Study   Clinical Study To Evaluate The Effectiveness Of Sadyovamana In Vegavastha Of Tamaka Shwasa(Acute Exacerbation of Bronchial Asthma)in Children 
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 Mahanya N C 
Designation  Post graduate scholar 
Affiliation  Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital Hassan 
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan

Hassan
KARNATAKA
573201
India 
Phone  9483442128  
Fax    
Email  mahanya132@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vijayalaxmi Mallannavar 
Designation  Associate Professor 
Affiliation  Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital Hassan 
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan

Hassan
KARNATAKA
573201
India 
Phone  9480624829  
Fax    
Email  abtittu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vijayalaxmi Mallannavar 
Designation  Associate Professor 
Affiliation  Sri Dharmasthala Manjunatheshwara college of Ayurveda and Hospital Hassan 
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan

Hassan
KARNATAKA
573201
India 
Phone  9480624829  
Fax    
Email  abtittu@gmail.com  
 
Source of Monetary or Material Support  
SDM College Of Ayurveda and Hospital Hassan 
 
Primary Sponsor  
Name  SDM College of ayurveda and hospital Hassan 
Address  SDM College of ayurveda and hospital Hassan 
Type of Sponsor  Private medical college 
 
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 Mahanya N C  SDM College of ayurveda and hospital Hassan  Room no 16 Dept Of Kaumarabhritya SDM College of ayurveda and hospital Hassan
Hassan
KARNATAKA 		 9483442128

mahanya132@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SDM College of ayurveda and hospital Hassan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:J209||Acute bronchitis, unspecified. Ayurveda Condition: TAMAKASVASAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-vamana-karma/ pracCardanam, वमन-कर्म/ प्रच्छर्दनम् (Procedure Reference: kashyapa samhitha, Procedure details: the child will be made to sit in the comfortable position & sweet rice yavagu will be given followed by akantapaana of ksheera followed by vamanoushada of 13 grams followed by yastimadhu phanta and vamana karma will be conducted)
(1) Medicine Name: vamanoushada, Reference: charaka samhitha, Route: Oral, Dosage Form: Kalka/ Paste, Dose: 13(g), Frequency: od, Duration: 1 Days
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  14.00 Year(s)
Gender  Both 
Details  Children aged 8 to 14 years irrespective of Gender and Socioeconomic status
Children whose parents are willing to give consent
Children fulfilling the Diagnostic Criteria
Children fit for Sadyovamana

 
 
ExclusionCriteria 
Details  Children with Severe complicated bronchial asthma needing intense care
Children with life threatening asthma detected by presence of any of the following
Cyanosis High grade fever
Children with Congenital Heart Diseases
Children unfit for Sadyovamana
Children with known case of other chronic respiratory conditions like tuberculosis cystic fibrosis or other acute illness that would complicate current treatment and response for asthma

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in symptoms of bronchial asthma especially wheezing breathlessness cough sleeplessness   7 days 
 
Secondary Outcome  
Outcome  TimePoints 
patient well being  7 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   Phase 3 
Date of First Enrollment (India)   01/09/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/09/2023 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
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 whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 [mahanya132@gmail.com].

  6. For how long will this data be available start date provided 15-01-2025 and end date provided 15-12-2025?
    Response (Others) -  one year post publication

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   The objective of the study is to evaluate the effectiveness of sadyovamana in the management of tamaka shwasa in children. 30 subjects with tamaka shwasa will be administered vamana oushadhi during vegavastha and sadyovamana will be induced. The subjects will be assessed using suitable scoring parameters. 
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