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CTRI Number  CTRI/2021/07/035309 [Registered on: 30/07/2021] Trial Registered Prospectively
Last Modified On: 24/11/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Safety and tolerability studies of Quercetin bar in healthy subjects 
Scientific Title of Study   A randomised Phase-I safety and tolerability study of two dosing regimens of Quercetin bar in healthy healthcare workers in a tertiary care hospital 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr BK Rao 
Designation  Chairman, Dept. of Critical Care Medicine 
Affiliation  Sir Ganga Ram Hospital New Delhi 
Address  Dr BK Rao Chairman Department of Critical Care Medicine Sir Ganga Ram Hospital Rajinder Nagar New Delhi 110060

Central
DELHI
110060
India 
Phone    
Fax    
Email  drbkrao@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr S Sarada Surya Kumari 
Designation  Scientist 
Affiliation  Defence Institute of Physiology and Allied Sciences  
Address  Defence Institute of Physiology and Allied Sciences Defence Research and Development Organization Min of Defence Lucknow Road Timarpur Delhi 110054

North
DELHI
110054
India 
Phone  9811576850  
Fax  011-23914790  
Email  saradasks@dipas.drdo.in  
 
Details of Contact Person
Public Query
 
Name  Dr Rashmi Rana 
Designation  Senior Scientist Dept of Research 
Affiliation  Sir Ganga Ram Hospital, New Delhi 
Address  Department of Research Sir Ganga Ram Hospital Rajinder Nagar New Delhi 110060

Central
DELHI
110060
India 
Phone  9873046361  
Fax    
Email  rashmi.rana@sgrh.com  
 
Source of Monetary or Material Support  
Defence Institute of Physiology and Allied Sciences DRDO Ministry of Defence Lucknow Road Timarpur,Delhi 110054 
 
Primary Sponsor  
Name  Director Defence Institute of Physiology and Allied Sciences 
Address  Defence Institute of Physiology and Allied Sciences DIPAS Defence Research and Development Organisation DRDO Min. of Defence Lucknow Road Timarpur Delhi 110054 
Type of Sponsor  Government funding agency 
 
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 
DR BK RAO   Sir Ganga Ram Hospital Ethics Committee New Delhi 110060  Department of Critical Care Medicine SIR GANGA RAM HOSPITAL RAJINDER NAGAR NEW DELHI110060 PH NO 9811177755
Central
DELHI 
9811177755

drbkrao@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee Sir GangaRam Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  safety and tolerability 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Quercetin bar  (i)Oral intervention of quercetin bar 500 mg OD for 14 days (ii) Oral intervention of quercetin bar 500mg BD (total 1000 mg) for 14 days  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  • Subject is a healthy male or female adult, aged 18 to 65 years on the day of enrolment
• Subject weighs at least 45 kg
• Subject willingness to participate in the study with signed Informed Consent Form
 
 
ExclusionCriteria 
Details  • Subject has any clinically significant illness which is likely to impact the safety of patient or may affect the results of the study
• Subject has a known hypersensitivity or allergy to quercetin
• Study subject is participating in another drug trial
• Study subject is female and is pregnant or may get pregnant during the study period
• Study subject unwilling to sign informed consent
• Study subject is unlikely to complete the study
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Safety and Tolerability of Quercetin Bar in Healthy Volunteers  o day, 14th day and 21st day 
 
Secondary Outcome  
Outcome  TimePoints 
Adverse events persisting beyond the last dose of Quercetin bar  after 14th day of quercetin bar supplementation ie
21st and 28th day 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)
Modification(s)  
16/08/2021 
Date of Study Completion (India) 25/10/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Quercetin is naturally occurring flavonoid found in various fruits, vegetables, tea, coffee and other beverages. It is a very good antioxidant, anti-inflammatory and immunomodulatory agent. It is an ideal molecule because its potential use against severe chronic diseases like ashthma, ARDS, arthritis, diabetis, cardiovascular problems, cancer and  anti-viral etc as been confirmed by systematic research. Quercetin targets several molecular pathways like NFkB, Hif-1alpha, NO, B2AR, PDE pathways and modulate different proteins like lung surfactants, tight junction proteins and maintains several physiological parameters in more or less similar to normal ranges without any toxicity and resistance. Based on the available literature it is expected to have prophylactic and therapeutic efficacy against COVID-19. Therefore, it is proposed that quercetin can be used for prevention of Covid-19 (SARS-CoV 2) infection in healthcare workers who are at risk of exposure and as an adjunct therapy for confirmed mild to moderate and severe of Covid-19.

The present study (Phase-I) is being conducted as a randomized study to assess the safety and tolerability of Quercetin at two dose regimens in Indian population/ health care workers. Quercetin will be supplied as individually packed nutracuetical bar (containing 500 mg of quercetin). Twenty healthy male and female volunteers will be enrolled and randomized in to 2 groups of 10 each. Group 1 will receive one Quercetin bar in the morning, whereas, Group 2 will receive 2 Quercetin bars (morning one and evening one) for 14 days. The subjects will have their scheduled Follow-up visits for recording of study parameters and clinical tests for a total period of 28 days (including 1 week extended follow up after 21 days). Health parameters including physiological and biochemical test will be conducted at 0 day, 14th day and on 21st day.


 
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