| CTRI Number |
CTRI/2024/04/065891 [Registered on: 18/04/2024] Trial Registered Prospectively |
| Last Modified On: |
10/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study On The immunomodulatory activity of Corina Plus Syrup® in children of age group 1-3 years for prevention of frequent upper respiratory diseases. |
|
Scientific Title of Study
|
A single arm open stage IV clinical study on the immunomodulatory activity of Corina Plus Syrup® in children of age group 1-3 years for prevention of frequent upper respiratory diseases. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sheetal D Pudale |
| Designation |
Ph D Scholar |
| Affiliation |
Bharati Vidyapeeth Deemed to Be University College of Ayurved Pune |
| Address |
Bharati Vidyapeeth Deemed to Be University College of Ayurved New Building 4th floor Department of Kaumarbhritya Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9325573597 |
| Fax |
|
| Email |
pudalesheetal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul Gujarathi |
| Designation |
Professor and HOD Department of Kaumarbhritya |
| Affiliation |
Bharati Vidyapeeth Deemed to Be University College of Ayurved Pune |
| Address |
Bharati Vidyapetth Deemed to Be University College of Ayurved Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9420322740 |
| Fax |
|
| Email |
shrigujarathi@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sheetal D pudale |
| Designation |
Ph D Scholar |
| Affiliation |
Bharati Vidyapeeth Deemed to Be University College Of Ayurved Pune |
| Address |
Bharati Vidyapeeth Deemed to Be University College Of Ayurved New Building 4th Floor Department of Kaumarbhritya Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9325573597 |
| Fax |
|
| Email |
pudalesheetal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati Vidyapeeth Deemed to Be University College Of Ayurved Pune |
|
|
Primary Sponsor
|
| Name |
Dr Sheetal D Pudale |
| Address |
Bharati Vidyapeeth Deemed to Be University College Of Ayurved Pune |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sheetal D Pudale |
Bharati Vidyapeeth Deemed to Be University Ayurved Hospital Pune |
Bharati Vidyapeeth Deemed to Be University Ayurved Hospital Ground Floor Department of Kaumarbhritya OPD No.09 Pune
Pune
MAHARASHTRA |
9325573597
pudalesheetal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth (Deemed to be University) Pune(India) College of Ayurved Pune Satara Road Pune ETHICS COMMITTEE [BV(DU) COA-EC] |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J399||Disease of upper respiratory tract, unspecified. Ayurveda Condition: KASAH, (2) ICD-10 Condition:J310||Chronic rhinitis. Ayurveda Condition: PRATISYAYAH/PINASAH, (3) ICD-10 Condition:J351||Hypertrophy of tonsils. Ayurveda Condition: TUNDIKERI, (4) ICD-10 Condition:J370||Chronic laryngitis. Ayurveda Condition: GALAGRAHAH, (5) ICD-10 Condition:J392||Other diseases of pharynx. Ayurveda Condition: SVARABEDAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Corina Plus , Reference: NA, Route: Oral, Dosage Form: Sharkara/ Syrup, Dose: 3.5(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
3.00 Year(s) |
| Gender |
Both |
| Details |
Children with complaints of frequent (at least 3-4 epi/3 months) upper respiratory diseases. |
|
| ExclusionCriteria |
| Details |
Children with LRTI, acute inflammatory pathology
Children with debilitating respiratory diseases like TB
3Children with chronic inflammatory diseases, acute respiratory infection.
Children with groin temperature more than 100F at the time of recruited.
Children with anatomical and congenital disorders.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| In 45 days we expected to reduction in frequency and severity of frequent upper respiratory tract morbidity by about 40-50% |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Outcome expected is sustenance 0f reduction in frequency and severity of frequent upper respiratory tract morbidity by about 50-60% |
90 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
25/04/2024 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
As per inclusion and exclusion criteria, study subject will be selected. Whole research procedure and aim
will be clearly informed to the
parents of study subject and informed proxy consent will be obtained from the
parents, case report format will be used to note the history and total
information of study subject regarding upper respiratory tract diseases.
On day 0, case report format will be
used to obtain the history of
study subject, on the same day
investigation will be done then treatment will be started with administration
of Corina Plus Syrup® will be given to subjects. Follow up will be taken after
every 15 days. Day of registration will be counted as day 0. |