FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/05/019482 [Registered on: 31/05/2019] Trial Registered Prospectively
Last Modified On: 31/05/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Crossover Trial 
Public Title of Study   To Study The Efficacy Of Kataphaladi Syrup In Pratishaya With Special Reference To Allergic Rhinitis In Children. 
Scientific Title of Study   AN EXPLORATORY CLINICAL STUDY TO EVALUATE THE EFFICACY OF KATAPHALADI SYRUP IN PRATISHYAYA IN THE 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 Rahul Ingole 
Designation  PG Scholar 
Affiliation  College of Ayurveda And Research Center, Nigdi, Pune 
Address  College of Ayurveda And Research Center, Nigdi,Pune

Pune
MAHARASHTRA
411044
India 
Phone  9890376572  
Fax    
Email  rahulingole26@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sudha singh 
Designation  Guide; Md (Kaumarbhritya) 
Affiliation  College of Ayurveda And Research Center, Nigdi, Pune 
Address  College of Ayurveda And Research Center, Nigdi,Pune

Pune
MAHARASHTRA
411044
India 
Phone  9975404439  
Fax    
Email  drsudha2010@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Rahul Ingole 
Designation  PG Scholar 
Affiliation  College of Ayurveda And Research Center, Nigdi, Pune 
Address  College of Ayurveda And Research Center, Nigdi,Pune

Pune
MAHARASHTRA
411044
India 
Phone  9890376572  
Fax    
Email  rahulingole26@gmail.com  
 
Source of Monetary or Material Support  
PDEAS College of Ayurveda And Research Centre,Nigdi Pune44 
 
Primary Sponsor  
Name  CARC nigdiPune  
Address  Nigdi pradhikaran sector 25 Pune 44 
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 Rahul Ingole  Kaumarbhritya OPD/IPD of Ayurveda General And Sterling Multi speciality Hospital, Nigdi, Pune  Sector 27, Sant Dyaneshwar Chowk, Pradhikaran, Nigdi, Pimpri-Chinchwad, Maharashtra 411044
Pune
MAHARASHTRA 
9890376572

rahulingole26@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B998||Other infectious disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Kataphaladi Syrup  kataphaladi syrup will be given orally to the children in between 3 to 12 yeas of age of the dose is calculated by clarks rule which is 1mg/kg/day and will be given 3 times in aday for 7 days/10days which include follow up 0, 3rd,5th,7thand 10th day. 
Comparator Agent  Nil  Not Applicable 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  1.Sign and symptoms of pratishtha mentioned in Ayurveda classics and allergic rhinitis according to modern texts.
2.pratishyaya of recent onset within one week 
 
ExclusionCriteria 
Details  1.Asthma,sinusitis, infectious disease like T.B. and other systematic disorders which interfere in the treatment.
2.Congenital anomalies related to respiratory system. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To study the efficacy of kataphaladi syrup in pratishyaya.  7 days/10 days with follow up at 0,3rd,5th,7th day and 10 days 
 
Secondary Outcome  
Outcome  TimePoints 
1.To study the disease pratishaya both in Ayurveda and modern parlance
2.To evaluate the adverse effects if any. 
7 days/10days with follow up at 0,3rd,5th,7th days and 10 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 1/ Phase 2 
Date of First Enrollment (India)   05/06/2019 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
Allergic rhinitis is one of the frequently troubling conditions especially in children. The symtoms of allergic rhinitis shows resemblance with the lakshanas of Pratishaya explained in ayurvedic classics.Pratishyaya is one of the disease in the which inflammation of mucous membrane of the nose is observed.In the management of pratushyaya in children needs more care and observation since the complication can make the condition adverse in the stage of its prognosis.If disease is not treated properly or neglected,it may cause complication like kasa. so, there is need for more effective treatment to eradicate this problem from root base.Ayurveda has potent herbal medicines possessing Aampachaka, immune modulatory antiallergic,anti-inflammatory and mucolytic effect which can be used for breacking the pathology of the disease at various levels and giving prompt symptomatic relief to the patient. Hence,the simple preparation Kataphaladi syrup which is having capacity of giving relief in pratishyaya as permentioned in classical Ayurvedic text is selected to find out its efficacy in management of pratishyaya in children.
Kataphaladi syrup will be given orally in the dosage of 1ml/kg/day as per Clark’s formula according to the weight divided 3times in a day for 10days. 
Close