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CTRI Number  CTRI/2019/04/018536 [Registered on: 10/04/2019] Trial Registered Prospectively
Last Modified On:
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ayurvedic medicine for treatment of common cold 
Scientific Title of Study   A comparative clinical study to evaluate the efficacy of Abhay lehya and sitopaladi lehya in the management of pratishyaya 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  Meghraj Golare 
Designation  PG scholar 
Affiliation  Parul institute of ayurved 
Address  OPD no 112,kaumarbhritya department,parul institute of ayurved hospital, parul university,limda

Vadodara
GUJARAT
391760
India 
Phone  8889321921  
Fax    
Email  golaremeghraj@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Meghraj Golare 
Designation  PG scholar 
Affiliation  Parul institute of ayurved 
Address  OPD no 112,kaumarbhritya department,parul institute of ayurved hospital, parul university,limda


GUJARAT
391760
India 
Phone  8889321921  
Fax    
Email  golaremeghraj@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Rajanish meti 
Designation  professor 
Affiliation  Parul institute of ayurved 
Address  OPD no 112,kaumarbhritya department,parul institute of ayurved hospital, parul university,limda

Vadodara
GUJARAT
391760
India 
Phone  9986660145  
Fax    
Email  rajanishsm@gmail.com  
 
Source of Monetary or Material Support  
Parul institue of ayurveda hospital 
 
Primary Sponsor  
Name  Parul institue of ayurved 
Address  Parul institute of ayurved , parul university , limda ,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 
Meghraj golare  Parul institute of ayurved hospital  Parul institute of ayurved hospital,parul university,limda
Vadodara
GUJARAT 
8889321921

golaremeghraj@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committe  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J00||Acute nasopharyngitis [common cold],  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Abhay Lehya  Abhay Lehya will be prepared in the pharmacy of Parul institute of ayurved as per s.o.p. given in A.F.I. Abhay Lehya will be given orally to the patients of pratishyaya(rhinitis) for 7 days.Dosage will be adjusted according to the age of children 
Comparator Agent  sitopaladi lehya  Sitopaladi Lehya will be prepared in the pharmacy of Parul institute of ayurved as per s.o.p. given in A.F.I. Sitopaladi Lehya will be given orally to the patients of pratishyaya(rhinitis) for 7 days.Dosage will be adjusted according to the age of children 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Clinical symptoms like Kshavthu,Nasasrava ,Netralalima ,Nasavarodha , Netrasrava , Shirashoola , Netrasrava , Nasasrava, Netralalima

Children whose mothers are consenting to participate in the drug trial.

Children with Pratishyaya of recent onset within one week. ( < 15 days )
 
 
ExclusionCriteria 
Details  Chronicity of the disease more than one week

Dusta pratisyaya, Jirna pratisyaya, Allergic rhinitis, Sinusitis, DNS, Nasal polyps, Asthma, Infectious diseases like Tuberculosis, systemic disorder
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Decrease in symptoms of pratishyaya  7 days 
 
Secondary Outcome  
Outcome  TimePoints 
changes in blood investigations like A.E.C.  7 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 2/ Phase 3 
Date of First Enrollment (India)   23/04/2019 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Respiratory diseases are quiet common especially in pediatric population. There are innumerable factors either exogenous or endogenous responsible for respiratory disease in children. In Modern science the common cold also known simply as a cold, is a viral infectious disease of the upper respiratory tract (URTI). Among these different diseases Pratishyaya (Rhinitis) is highly prevalent in all seasons especially in children. According to Ayurveda “pratishanam shyayate iti pratishyayas” it means continuous outward movement of doshathough nostrils. Because of dushti of doshas patient having complaints like, Nasasrava, Nasavarodha, Kshavathu, Shirashoola, Netrasrava and Netralalima etc. In most of instances change of season or exposure to the causative factors are the responsible etiological factors in the pathogenesis of Pratishyaya.

Abhay ghrita is an Ayurvedic medicine that has been described in Kashyap Samhita chikitsasthan, pratishyayeadhyaye composing of Bhrahmi, Sasharp, Kushtha, Sariva, Vacha & Pippali. In Ashtanga Hridaya the grita having same ingredients has been mentioned by  the name of Bhrahmyadi Ghrita. Considering the difficulty in the administration of ghrita due to less palatability, same ingredients will be modified into Lehya form. 

According to classical reference as well as the experience of use of drug by different Ayurveda practitioner; Sitopaldi Churna explained in Charaka Samhita has good result in treating Pratishyaya. Considering the palatability, changing the form may make it easy to administer Sitopaldi Churnaa as Sitopaldi Avaleha in children. In this study Pratishyaya has been treated with division of two groups providing 1st group with Sitopaladi Avaleha & 2nd group with Abhay Avaleha .

 

 
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