CTRI Number |
CTRI/2019/04/018536 [Registered on: 10/04/2019] Trial Registered Prospectively |
Last Modified On: |
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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 |
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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 |
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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 |
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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 |
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Details of Secondary Sponsor
|
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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
|
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Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: J00||Acute nasopharyngitis [common cold], |
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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 |
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Inclusion Criteria
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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
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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)?
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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 . |