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CTRI Number  CTRI/2019/05/019294 [Registered on: 23/05/2019] Trial Registered Prospectively
Last Modified On: 11/07/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Siddha 
Study Design  Single Arm Study 
Public Title of Study   Clinical trial of Adathoda rasayanam for the management of bronchial asthma in children 
Scientific Title of Study   Clinical evaluation of Adathoda rasayanam for the management of soolikanam(childhood asthma)in children  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr P Jayapriya 
Designation  PG Scholar 
Affiliation  National institute of siddha 
Address  Department of Kuzhandhai Maruthuvam,Ayothidass pandithar hospital,National institute of siddha,Tambaram sanatorium,chennai
Department of Kuzhandhai Maruthuvam,Ayothidass pandithar hospital,National institute of siddha,Tambaram sanatorium,chennai
Kancheepuram
TAMIL NADU
600047
India 
Phone  6380680879  
Fax    
Email  drjayapriya93@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr M Meenakshi sundaram 
Designation  Head of the department 
Affiliation  National institute of siddha 
Address  Department of Kuzhandhai Maruthuvam,Ayothidass pandithar hospital,National institute of siddha,Tambaram sanatorium,chennai
Department of Kuzhandhai Maruthuvam,Ayothidass pandithar hospital,National institute of siddha,Tambaram sanatorium,chennai
Kancheepuram
TAMIL NADU
600047
India 
Phone  9444214582  
Fax    
Email  mmssiddha@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr K Suresh 
Designation  Lecturer 
Affiliation  National institute of siddha 
Address  Department of Kuzhandhai Maruthuvam,Ayothidass pandithar hospital,National institute of siddha,Tambaram sanatorium,chennai
Department of Kuzhandhai Maruthuvam,Ayothidass pandithar hospital,National institute of siddha,Tambaram sanatorium,chennai
Kancheepuram
TAMIL NADU
600047
India 
Phone  9962571137  
Fax    
Email  drsureshherbal@gmail.com  
 
Source of Monetary or Material Support  
Dr P Jayapriya,PG scholar,department of kuzhandhai maruthuvam,National institute of siddha,Tambaram sanatorium,chennai 
 
Primary Sponsor  
Name  Dr P Jayapriya 
Address  National institute of siddha,Tambaram sanatorium,chennai 
Type of Sponsor  Other [Research student] 
 
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 P Jayapriya  National institute of siddha  Department of Kuzhandhai Maruthuvam,Ayothidass pandithar hospital,Tambaram sanatorium,chennai
Kancheepuram
TAMIL NADU 		 6380680879

drjayapriya93@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: J454||Moderate persistent asthma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Adathoda rasayanam  Adathoda rasayanam, dosage 170 mg-3-4 years,500mg-5-7 years,oral route for 45 days  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  7.00 Year(s)
Gender  Both 
Details  Cough,Wheezing,Tightness of chest,Shortness of breath,Abdominal bloating,Loss of appetite 
 
ExclusionCriteria 
Details  Hemoptysis,Active primary complex,Congenital heart disease,Pneumonia,Status Asthmaticus,Any other serious illness 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Efficacy of the trial drug is measured by peak expiratory flow meter  28 days 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in the recurrence of the disease and improvement in the quality of life of children,Improvement in clinical symptoms  3 months 
 
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 
Date of First Enrollment (India)   26/05/2019 
Date of Study Completion (India) 07/04/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   It is single non randomized open-label trial to determine the efficacy of Adathoda rasayanam for the management of Soolikanam.In the trial 30 Childhood asthma patients will be recruited and the trial drug Adathoda rasayanam will be administrated orally after food thrice a day.During the study period all the study related data will be recorded and documented in seperate trial master file for each and every patients.During the trial period if the patient develop any adverse effect he/she will be immediately referred to the chairman,pharmaco-vigilance commitee,NIS.If it will be mild event,the patient will be treated in OPD-NIS.If the event will be reserve,the patient will be referred to nearby Government Hospital and will be take over the patient,until he/she will get recovery.The treatment will be provided with free of cost.The entire trial will be monitored by yhe research monitoring commitee of NIS.During this trial all the safety and efficacy parameters will be recorded in CRF.After completion of the trial all the study related data will be analysed statistically.The outcome of this trial willbe publishes in Indian Journal of Medical Research.  
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