| CTRI Number |
CTRI/2022/12/048270 [Registered on: 19/12/2022] Trial Registered Prospectively |
| Last Modified On: |
05/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Safety and Efficacy study of Nasal Spray on Children and Adolescents with common cold |
|
Scientific Title of Study
|
A Double-Blind, Randomized, Parallel Clinical Study to Evaluate the Efficacy and Safety of Nasal Spray in Paediatric and Adolescent Subjects with Symptoms of Common Cold |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| LCBS-NS-106 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramesh M |
| Designation |
Professor |
| Affiliation |
BGS Global Institute of Medical Sciences |
| Address |
BGS Global Institute of Medical Sciences
No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA
560060
India |
| Phone |
9877980038 |
| Fax |
|
| Email |
drrameshm.research@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
| Address |
#9,1st Floor, Mythri Legacy, Chelekere Main Road, Kalyan Nagar (PO)
Bangalore
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jestin V Thomas |
| Designation |
Director |
| Affiliation |
Leads Clinical Research and Bio Services Pvt. Ltd |
| Address |
#9,1st Floor, Mythri Legacy, Chelekere Main Road, Kalyan Nagar (PO)
KARNATAKA
560043
India |
| Phone |
9845125293 |
| Fax |
|
| Email |
jestin.leadsclinbio@gmail.com |
|
|
Source of Monetary or Material Support
|
| ITC Life Sciences and Technology Centre, Peenya Industrial Area, No. 3, 1st Main, 1st Phase, Bangalore – 560 058 |
|
|
Primary Sponsor
|
| Name |
ITC Life Sciences and Technology Centre |
| Address |
Peenya Industrial Area, No. 3, 1st Main, 1st Phase, Bangalore –560058
|
| Type of Sponsor |
Other [FMCG] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ramesh M |
BGS Global Institute of Medical Sciences |
No.67, BGS Health and Education City, Uttarahalli Road, Kengeri
Bangalore
KARNATAKA |
9877980038
drrameshm.research@gmail.com |
| Dr Vishwanath Bhat BK |
Radhakrishna Multispeciality Hospital & IVF Center |
3-4, Sunrise Tower, J.P Road, Girinagar
Bangalore
KARNATAKA |
892121955
drvishwanath.research@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, BGS Global Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee, BGS Global Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:J00||Acute nasopharyngitis [common cold]. Ayurveda Condition: pratysyaya, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: ITC Nasal Spray with Tulsi and Mulethi extract, Reference: NA, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 1(NA), Frequency: tds, Bhaishajya Kal: Muhurmuhu, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm | Drug | Other than Classical | | (1) Medicine Name: Placebo Nasal Spray, Reference: NA, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 1(NA), Frequency: tds, Bhaishajya Kal: Muhurmuhu, Duration: 14 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects with common cold symptoms.
2.Subjects with cold symptom severity within the specified score range.
3.Subject who agrees to give informed consent / assents and comply with the study procedures.
|
|
| ExclusionCriteria |
| Details |
1. Subjects with history/presence of clinically significant condition/disorder/allergy to herbal products (self-reported), or regularly consuming certain products as per invetigator judgement could interfere with the results of the study or the safety of the subject.
2. Subjects tested positive for SARS-CoV-2 by Rapid Antigen Test.
3. Subjects who test negative for viral load at baseline.
4. Subjects with co-existing bacterial/secondary infections.
5. Subjects having taken influenza vaccination within the last 3 months prior to screening visit.
6.Subjects having common cold or flu like symptoms for > 48 hours. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mean change in Total Symptom Score (TSS) and Viral Load at different time points in treatment arm in comparison with Baseline and comparator |
Day 2/ 3/ 4/ 5/ 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Mean change in efficacy parameters including Questionnaire based assessments at different time points up to 21 days |
Upto Day 21 |
| Percent of individuals with relapse post intervention |
Upto Day 21 |
| Overall product safety |
Upto Day 21 |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
19/12/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a double blind, randomized (1:1), comparator
controlled, parallel-group, multi-centre study to test the product safety and
efficacy in relieving cold symptoms in Paediatric and Adolescent subjects with
early symptoms of common cold and meeting all inclusion and no exclusion
criteria. Study duration is for 21 days with intervention period of 14 days.
After passing the eligibility criteria, written Informed
consents and Assents will be obtained and the subjects will be randomized into
one of the 2 treatment groups as per randomization schema. Homogenous and
Uniform
distribution of subjects in both groups basis symptom severity
(Mild and
Moderate), gender, mean age yrs will be attempted.
Cold severity as per specific measures, Local irritation will
be assessed by Investigator and Subjects / parents/ Guardians under supervision
of study Investigator / personnel at specified frequency.
Viral load assessment
through nasal swabs will be performed on Day 1 and Day 4. Subjects will be
given a detailed instruction on product use and recording in the subject dairy. |