| 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
|
|
|
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
|
|
|
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. |