CTRI Number |
CTRI/2020/05/025317 [Registered on: 22/05/2020] Trial Registered Prospectively |
Last Modified On: |
26/07/2020 |
Post Graduate Thesis |
No |
Type of Trial |
PMS |
Type of Study
|
Ayurveda |
Study Design |
Single Arm Study |
Public Title of Study
|
SURVEY OF MOUTH-DISSOLVING TURMERIC LOZENGES IN HEALTHCARE WORKERS |
Scientific Title of Study
|
ASSESSMENT OF CLINICAL ACCEPTABILITY OF MOUTH-DISSOLVING TURMERIC LOZENGES IN HEALTHCARE WORKERS INVOLVED IN COVID-19 |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Niharika Gill |
Designation |
HOD Department of Medicine |
Affiliation |
K J Somaiya Medical College |
Address |
K J Somaiya Medical college, Eastern Express Highway, Sion Eastern Express Highway, Sion Mumbai (Suburban) MAHARASHTRA 400022 India |
Phone |
24090253 |
Fax |
|
Email |
niharika@somaiya.edu |
|
Details of Contact Person Scientific Query
|
Name |
DR MANJUSHA RAJARSHI |
Designation |
Medical Researcher |
Affiliation |
Consultant, Gelnova Labs India Pvt Ltd. |
Address |
Summit plot 11 flat 2
Amritvan complex
Goregaon Summit plot 11 flat 2
Amritvan complex
Goregaon Mumbai (Suburban) MAHARASHTRA 400063 India |
Phone |
9820315688 |
Fax |
|
Email |
manjusharajarshi@gmail.com |
|
Details of Contact Person Public Query
|
Name |
DR MANJUSHA RAJARSHI |
Designation |
Medical Researcher |
Affiliation |
Consultant, Gelnova Labs India Pvt Ltd. |
Address |
Summit plot 11 flat 2
Amritvan complex
Goregaon Summit plot 11 flat 2
Amritvan complex
Goregaon Mumbai (Suburban) MAHARASHTRA 400063 India |
Phone |
9820315688 |
Fax |
|
Email |
manjusharajarshi@gmail.com |
|
Source of Monetary or Material Support
|
Sponsored project: study grant from pharmaceutical industry |
|
Primary Sponsor
|
Name |
Ms Gelnova Laboratories India Pvt Ltd |
Address |
C-125, TTC Industrial Area, Mahape, Navi Mumbai 400703 |
Type of Sponsor |
Pharmaceutical industry-Indian |
|
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 Niharika Gill |
KJ Somaiya Medical College and Hospital |
SOMAIYA AYURVIHAR COMPLEX EVERARD NAGAR, NEAR EASTERN EXPRESS HIGHWAY Mumbai (Suburban) MAHARASHTRA |
24090253
niharika@somaiya.edu |
|
Details of Ethics Committee
Modification(s)
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
K. J. SOMAIYA MEDICAL COLLEGE, RESEARCH CENTER KJSMC HOSPITAL AND RESEARCH CENTER SOMAIYA AYURVIHAR COMPLEX EVERARD NAGAR, NEAR EASTERN EXPRESS HIGHWAY MUMBAI |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Healthcare team serving duties at COVID-19 wards |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Not applicable |
Not applicable |
Intervention |
TURMGEL MOUTH DISSOLVING LOZENGE 100 MG |
EACH SOFT GELATINE LOZENGE CONTAINS TURMERIC EXTRACT 100 MG
3 LOZENGES DAILY FOR 1 MONTH.
SUCK SLOWLY; DO NOT CHEW |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
55.00 Year(s) |
Gender |
Both |
Details |
Healthcare professionals and paramedic staff serving COVD-19 will be enrolled in the study.
Inclusion criteria:
a. All adult individuals of both sexes working in COVID-19 wards.
b. Individuals willing to give informed consent
c. Individuals with no prior history of COVID-19 infections
d. Individuals currently not showing any symptoms of COVID-19 at the time of recruitment
e. Individuals with no history and / or currently ongoing serious chronic health condition
f. Willing to follow the protective majors as advised
g. Willing to comply with the study protocol
|
|
ExclusionCriteria |
Details |
a. Any history of allergy to turmeric and /or any of the ingredients used in making of the lozenge.
b. Refusal for informed consent.
c. Concurrent ongoing other infections.
d. Any current medical history that investigator may consider not advisable to work in COVID-19 ward.
|
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Clinical acceptability of turmeric lozenges in COVID-19 healthcare teams |
DAY 15 (follow up 1) and DAY 30 (end of study) are evaluation time points. |
|
Secondary Outcome
|
Outcome |
TimePoints |
Safety and tolerance of turmeric lozenges |
End of study period at D 30 |
|
Target Sample Size
|
Total Sample Size="300" Sample Size from India="300"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="304" |
Phase of Trial
|
Post Marketing Surveillance |
Date of First Enrollment (India)
|
26/05/2020 |
Date of Study Completion (India) |
09/07/2020 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
The study results will be published in an appropriate journal |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Study Protocol Number: PMS/TURMGEL/2020/01 Considering the spread of COVID-19 and the contagious nature of this virus, accidental contamination of the healthcare worker is not ruled out and there are reports of healthcare teams contracting the infection. Therefore, apart from infection control practices, an intervention to reduce bioburden in the oral cavity by using a mouth dissolving lozenge of turmeric extract 100 mg (Brand name Turmgel) exhibiting antiseptic properties is proposed in this project. Turmeric is a naturally occurring plant derived antiseptic agent with known anti-bacterial, anti-fungal, antiviral properties. Additionally, it is known for its anti-inflammatory, antioxidant and immunomodulatory activities. It has multiple pharmacological actions with well supported use in traditional medicine. The principle constituent of turmeric is curcumin and it has wide spectrum of activity which is being explored in modern medicine. The use of turmeric and its constituents could not be capitalised till date due to its poor bioavailability and first pass effect. This has rendered to its limited use in the modern medicine. However, the galenicl development and technological advancements in drug delivery system has helped develop a supra-bioavailable mouth dissolving lozenge of pure turmeric extract. This product is marketed In India and is manufactured by M/s Gelnova Laboratories (I) Private Limited Mumbai and it’s globally patented. Turmeric is part of food chain with wide safety margin and is well-endorsed in Ayurveda. This product dissolves in mouth and as it dissolves, the active constituents are available to exert its pharmacological activities. It takes around 8-10 minutes for the lozenge to dissolve in the mouth; this contact time is very effective to maintain oral hygiene as the solubilised turmeric extract in the saliva reaches each part of the mouth-cavity capable to reduce the bioburden. Thus, colonisation of the pathogens near pharynx can be arrested. Antiviral properties of turmeric (curcumin) on several different viral species is well supported in the literature. As COVID-19 is a newly emerged virus from the family of coronaviruses, a direct evidence on this strain is currently not available. However, few recent literature and scientific research emerging from China does demonstrate potential use of turmeric in COVID-19. This formulation is SUGAR-FREE. Hence no nutrients are available for germs to proliferate. It is mildly flavoured with eucalyptus oil and menthol. This is an open, clinic-based, non-comparative, single-centre, post-marketing observational qualitative survey. Three lozenges daily during the work-hours is recommended over the study period of 30 days. Healthcare workers will continue to allow the infection control practices and shall use all the necessary protective gears as recommended. There are total 3 visit during the 1 month study period: baseline, follow up at day 15 and end of study at Day 30. Any of the healthcare workers, showing any symptoms of COVID-19 will be withdrawn from the study. The primary criteria includes Clinical acceptability of turmeric lozenges in COVID-19 healthcare teams that will be measured through VAS. Investigator shall opine on the safety and tolerance of turmeric lozenges. (secondary criteria) This intervention is to protect our healthcare workers from contracting COVID-19 while performing professional duties. The study hypothesis considers arresting the pathogen in the buccal cavity and do not permit its entry through respiratory tract. The viral load of COVID-19 is in the saliva and the study medication TURMERIC LOZENGES solubilises in the saliva. Therefore, we believe that the study medication has high possibility to reduce the salivary load and reduce the chance of contracting infection. The last subject last visit was achieved on 9th July 2020. |