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CTRI Number  CTRI/2020/01/023055 [Registered on: 30/01/2020] Trial Registered Prospectively
Last Modified On: 29/01/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Ayurvedic treatment of childhood bronchial asthma  
Scientific Title of Study   A clinical study of haridradi avaleha in the management of tamaka shwasa with special reference to childhood bronchial asthma 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rimpi Majumder  
Designation  PG Scholar  
Affiliation  Parul Institute of Ayurved  
Address  1st Floor Room no 204, Department of Kaumarbhritya, Parul Institute of Ayurved, Parul University,Post limda, Tal. Waghodia, Vadodara Vadodara,GUJARAT

Vadodara
GUJARAT
391760
India 
Phone  7499123928  
Fax    
Email  dr.rimpi1992@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Aboli Patil  
Designation  Professor  
Affiliation  Parul Institute of Ayurved 
Address  1st Floor Room no 204, Department of Kaumarbhritya, Parul Institute of Ayurved, Parul University,Post limda, Tal. Waghodia, Vadodara Vadodara,GUJARAT

Vadodara
GUJARAT
391760
India 
Phone  9422783313  
Fax    
Email  drabolipatil@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Aboli Patil  
Designation  Professor 
Affiliation  Parul Institute of Ayurved 
Address  1st Floor Room no 204, Department of Kaumarbhritya, Parul Institute of Ayurved, Parul University,Post limda, Tal. Waghodia, Vadodara Vadodara,GUJARAT

Vadodara
GUJARAT
391760
India 
Phone  9422783313  
Fax    
Email  drabolipatil@gmail.com  
 
Source of Monetary or Material Support  
Parul Institute of Ayurved, Department of Kaumarbhritya, P.O.Limda, Ta.Waghodiya-391760.Dist-Vadodara(Gujrat). 
 
Primary Sponsor  
Name  Department of Kaumarbhritya 
Address  Parul Institute of Ayurved, Parul University,Post Limda, Tal,Waghodia, Vadodara 
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 Rimpi Majumder  Parul Ayurved Hospital   Opd No 112,Department of Kaumarbhritya, Parul Ayurved Hospital,Post-Limda,Tal-Waghodiya-391760,Dist.Vadodara (Gujrat)
Vadodara
GUJARAT 		 7499123928

dr.rimpi1992@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee of Human Research   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Haridradi Avaleha  Dosage (Age group 5 TO 8 Years)- 20gms,(Age group 9 To 12 Years)-30gms,(Age group 13 To 16 Years)-45gms two times per day before food Route of Administration-Oral Duration 60 Days  
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  1 subject with age group 5 to 16 Years will be included in the study irrespective of sex , Caste & religion.
PEFR>60% of personal best
Intermittent, Mild persistent, Moderate persistent cases of childhood bronchial asthma.
 
 
ExclusionCriteria 
Details  Age below 5 and more than 16 Years.
PEFR<60% of personal best.
Severe persistent cases of asthma.
Patients taking oral or inhaled steriods on regular basis. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
frequency of shwasa vegas, wheezing, kapha, night symptoms, relief in sitting posture etc symptoms will be reliefed  15thday, 30th day, 45th day, 60th day 
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable  Not applicable 
 
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 1/ Phase 2 
Date of First Enrollment (India)   30/01/2020 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   1. Bronchial asthma,the commonest chronic respiratory disease in childhood,is characterised by reccurent paroxymal wheeze and respiratory distress.Although asthma can occur in people of any age,infants,most 
children with the illness developed it by about the age of (5-16)years.
 
2.Children with lower immunity become more susceptible to lower respiratory disorder.It is one of the most common chronic disease among children causing substantial morbidity. 

3. The current management of tamaka shwasa(childhood bronchial asthma) by modern medicine is only providing short term symptomatic relief but does not provide any long term  relief to the patient. In the 
present scenario Ayurveda has many drugs which are safe and effective in the treatment of Tamaka shwasa and also useful to prevent the recurrence of attacks and promoting the growth of children at the same time.

4.Therefore Ayurveda herbal combination Haridradi avaleha mentioned in Gadanigraha Hikkashwasadhikar is taken as trial drug in this study. 

 
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