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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 Trial 
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  
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 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  
Status 
Not Applicable 
 
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  
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.

 

 
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