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CTRI Number  CTRI/2021/08/035662 [Registered on: 13/08/2021] Trial Registered Prospectively
Last Modified On: 27/05/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A Study to assess the Efficacy and Safety of Goviro Soft Gel Capsule as an adjuvant with Imunocin tablet and Standard of care in patients with Upper Respiratory Tract Infection  
Scientific Title of Study   An Open Label, Prospective, Randomized, Parallel, Multi-center, Multi-Arm, Comparative Study to Assess the Efficacy and Safety of Goviro Soft Gel Capsule as an adjuvant with Imunocin tablet and SOC in patients with Upper Respiratory Tract Infection 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
GB_GOV_001_21  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sailee Kadam 
Designation  AGM Medical Services 
Affiliation  Gufic Biosciences Limited 
Address  SM House 11 Sahakar Road Vile Parle East Mumbai Maharashtra Mumbai MAHARASHTRA 400057 India

Mumbai
MAHARASHTRA
400057
India 
Phone  9869350948  
Fax    
Email  herbalmed@guficbio.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sailee Kadam 
Designation  AGM Medical Services 
Affiliation  Gufic Biosciences Limited 
Address  SM House 11 Sahakar Road Vile Parle East Mumbai Maharashtra Mumbai MAHARASHTRA 400057 India


MAHARASHTRA
400057
India 
Phone  9869350948  
Fax    
Email  herbalmed@guficbio.com  
 
Details of Contact Person
Public Query  
Name  Mr Vairamuthu Ammaiyappan 
Designation  Associate Director Project Management 
Affiliation  iDD Research Solutions Pvt Ltd 
Address  Tek Meadows Campus No 51 3rd C block Old Mahabalipuram Rd Sholinganallur Chennai Chennai TAMIL NADU 600119 India

Chennai
TAMIL NADU
600119
India 
Phone  9606829331  
Fax    
Email  vairamuthu.ammaiyappan@iddresearch.com  
 
Source of Monetary or Material Support  
Gufic Biosciences Limited 
 
Primary Sponsor  
Name  Gufic Biosciences Limited 
Address  SM House 11 Sahakar Road Vile Parle East Mumbai Maharashtra India 400057 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr M Satish  Ashirwad Nursing Home  Room Number 01, Clinical Research Department, Rajgir Sadan, Ground Floor, Laxmi Baug, Opp. Sion Rly. Stn., Sion (West), Mumbai - 400 022
Mumbai
MAHARASHTRA 		 9869055473

drmsatish1970@gmail.com 
Dr Vijay Warad  Sai Netralaya And Speciality Clinic  Room Number 10, Research Department, 102 A 2 wing araneshwar Park Phase 2 Sahkarngar Pune 411009
Pune
MAHARASHTRA 		 9822436184

vijaypwarad@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee of Aayush Hospital  Approved 
Royal Pune Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J00-J06||Acute upper respiratory infections,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Goviro Soft Gel Capsules  One Soft gel capsule twice a day for 7 days; immediately after meals is recommended. 
Intervention  Imunocin tablet  One tablet twice a day for 7 days is recommended. 
Comparator Agent  Standard of Care  SOC treatment will be given as per the treating investigator 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Male/female of ≥18 and ≤65 years of age
2. Patient who can and willing to provide written Informed Consent
3. Patient with at least 2 symptoms of URTI (Sneezing, Runny nose, nose block, sore throat, fever, fatigue) since last 48 hours
4. Patient who can take medicines orally
5. Female of childbearing potential must have a negative urine pregnancy test and be non-lactating at screening visit
6. Patient/ patient’s legally acceptable representative understands and can comply with clinical trial protocol requirements
 
 
ExclusionCriteria 
Details  1. Patient Ë‚ 18 or ˃ 65 years of age
2. Pregnant and/or nursing woman
3. Patient with clinical evidence of a lower respiratory tract infection, as determined by the Investigator at the time of screening
4. Patient with anticipated need for hospitalization or emergency room care within 24 hours of screening
5. Patient with any other clinically significant illness
6. Patient with cases/ instances of severe vomiting which would affect oral administration of medicine
7. Patient taking any medication or having an indication that might point to an increased risk, associated with study participation or study drug administration or may interfere with the interpretation of study results and in the judgment of the study personnel, would make the subject inappropriate for inclusion
8. Patient who has participated in another trial with an investigational drug within 3 months prior to this trial.
9. Patient with history of malignancy, Cardiovascular Disease (CVD), Stroke, etc.
10. Patient with moderate to severe COVID 19 symptoms
11. Patient with any other condition, which as per the investigator would jeopardize the outcome of the trial
12. Patients who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Mean change in WURSS-21 score from Screening Visit/ Enrolment Visit/ Baseline Visit (Day 0) to End of treatment (Day 7).

Change in Cold symptom scale score from Screening Visit/ Enrolment Visit/ Baseline Visit (Day 0) to End of treatment (Day 7).
 		 Mean change in WURSS-21 score from Screening Visit/ Enrolment Visit/ Baseline Visit (Day 0) to End of treatment (Day 7).

Change in Cold symptom scale score from Screening Visit/ Enrolment Visit/ Baseline Visit (Day 0) to End of treatment (Day 7).
 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in number of doses of Antibiotics from Baseline to End of treatment.
Change in Complete Blood Count (CBC), Erythrocyte sedimentation rate (ESR), C- Reactive Protein (CRP) from Screening Visit/ Enrolment Visit/ Baseline Visit to End of treatment
Change in following parameters form Screening Visit/ Enrolment Visit/ Baseline Visit and End of treatment
BUN
Serum creatinine
Liver Function Tests (LFT) Parameters

 		 Baseline (Day 0) to End of treatment (Day 7). 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "66"
Final Enrollment numbers achieved (India)="66" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/08/2021 
Date of Study Completion (India) 20/04/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="15" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Sixty patients with upper respiratory tract infection will be included in this study. Patients will be enrolled into the study based on Inclusion & Exclusion Criteria, patient history, and safety measures. The duration of each patient’s participation in the study will be of approximately 14 days. There will be total 05 visits  (02 site visits and 03 virtual visits) during the study. 

 Patients will be instructed to take IPs, with ambient temperature water for total 07 consecutive days at home.  SOC treatment will be given as per the treating investigator. Instructions will be given for the same.


Treatment Arm 1: Control group on SOC 

Treatment Arm 2: Goviro soft gel capsule [one capsule twice a day after meals (lunch & dinner) ] along with SOC

Treatment Arm 3: Goviro soft gel capsule [one capsule twice a day after meals (lunch & dinner)] + Imunocin tablet (one tablet twice a day) along with SOC


 Patients will be given WURSS-21 questionnaire to record their daily symptoms at home. They will be also given cold symptom score scale.

 

Patients will be followed up telephonically on Day 14 (Visit 5, virtual visit) for capturing details of adverse events and concomitant medications.

 
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