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CTRI Number  CTRI/2018/11/016244 [Registered on: 01/11/2018] Trial Registered Prospectively
Last Modified On: 31/05/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Assessment of Red Ginseng mouthwash against dental tartar and gum bleeding 
Scientific Title of Study   Comparative Assessment of the action of a commercially available Panax ginseng extract containing mouthwash with that of a Chlorhexidine and Sodium Fluoride containing mouthwash against dental Plaque and Gingival bleeding - A Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  H CYRIL BENEDICT 
Designation  POSTGRADUATE STUDENT 
Affiliation  TAMILNADU GOVERNMENT DENTAL COLLEGE AND HOSPITAL, CHENNAI 
Address  No-3, Dulukkanam Street, Village High Road, Sholinganallur, Chennai 600119

Chennai
TAMIL NADU
600119
India 
Phone  9962365831  
Fax    
Email  cyrilbene@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr M B Aswath Narayanan 
Designation  Professor and Head of the Department 
Affiliation  Tamil NAdu Government Dental College and Hospital, Chennai 
Address  Room No 4, Department of Public Health Dentistry, Tamil Nadu Government Dental College and Hospital, No-2, Frazer Bridge Road, Parktown Chennai
Room No 4, Department of Public Health Dentistry, Tamil Nadu Government Dental College and Hospital, No-2, Frazer Bridge Road, Parktown Chennai
Chennai
TAMIL NADU
600003
India 
Phone  9840127997  
Fax    
Email  mban1965@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  H CYRIL BENEDICT 
Designation  POSTGRADUATE STUDENT 
Affiliation  TAMILNADU GOVERNMENT DENTAL COLLEGE AND HOSPITAL, CHENNAI 
Address  No-3, Dulukkanam Street, Village High Road, Sholinganallur, Chennai 600119

Chennai
TAMIL NADU
600119
India 
Phone  9962365831  
Fax    
Email  cyrilbene@gmail.com  
 
Source of Monetary or Material Support  
self 
 
Primary Sponsor  
Name  self 
Address  No 3, dulukkanam street, village high road, sholinganallur, chennai 600119 
Type of Sponsor  Other [self] 
 
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 
H Cyril Benedict   Tamil Nadu Government Dental College and Hospital, chennai  room no 4, department of Public health dentistry, Tamil NAdu government Dental College and hospital, No 2, Frazer Bridge Road, Parktown, Chennai
Chennai
TAMIL NADU 
9962365831

cyrilbene@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
TAMILNADU GOVERNMENT DENTAL COLLEGE AND HOSPITAL - INSTITUTIONAL REVIEW BOARD  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K051||Chronic gingivitis, (2) ICD-10 Condition: K051||Chronic gingivitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Chlorhexidine 0.2% mouth rinse  The product contains Chlorhexidine gluconate in the amount of 0.2% . the patiets are advised to rinse and spit out 10ml of the mouth rinse twice a day 
Intervention  Panax ginseng extract containing mouth rinse  the product contains red ginseng extract in the amount of 0.010 w/w%. the patiets are advised to rinse and spit out 10ml of the mouth rinse twice a day.  
Comparator Agent  sodium fluoride mouth rinse  The product contains sodium fluoride in the amount of 0.2%. the patients are advised to rinse and spit out 10ml of the mouth rinse twice a day 
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  subjects with completely erupted permanent dentition 
 
ExclusionCriteria 
Details  subjects with advanced oral diseases
subjects with history of systemic diseases
subjects with history of antibiotic usage in the last one month
subjects with history of tobacco use
subjects with history of alcohol intake
subjects wearing fixed or removable orthodontic or prosthodontic appliances
subjects with known history of hypersensitivity to red ginseng extract pr chlorhexidine or sodium fluoride
subjects who are physically and mentally challenged
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Plaque Index by Silness and Loe 1964
Gingival Index by Loe and Silness 1963 
the index scores will be obtained from the patients at the time of recruitment(baseline), at 2 weeks m at 4 weeks and at 6th week 
 
Secondary Outcome  
Outcome  TimePoints 
subjective reduction in the bleeding of gums   the index scores will be obtained from the patients at the time of recruitment(baseline), at 2 weeks m at 4 weeks and at 6th week 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   05/11/2018 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="3"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   no applicable 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Dental caries and Periodontal diseases are the two most common diseases of the mankind. Dental plaque is the common etiological factor for both of these disease conditions. apart from mechanical plaque control, chemical plaque control through the use of mouth rinse may aid as a valuable adjunct in controlling  and the pathogenic microbes in dental plaque which cause these diseases. many chemical plaque controlling agents were in use, but with significant side effects like staining of teeth, alteration of taste perception, dental calculus build up, allergic reactions in the oral cavity, development of white patches etc. thus a natural and culturally acceptable, cost-effective chemical agents which has less or no side effects is desirable in this context. red ginseng is one such product which has proven systemic benefits and has been used for various systemic diseases . this intervention study therefore aims to measure the benefits of red ginseng extract containing mouth rinse against gingivitis and gingival bleeding. chlorhexidine gluconate and sodium fluoride  mouth rinses served as positive controls. 90 patients are to be recruited with 30 patients in each of the 3 groups. 1st group was given the red ginseng extract containing mouth rinse, 2nd group was given Chlorhexidine gluconate mouth rinse and 3rd group was given Sodium Fluoride mouth rinse. informed consent will be obtained from the patients before recruiting them for the study. outcome variables measured were Index values of Plaque Index and gingival index at baseline, 2 weeks, 4 weeks and at 6 weeks. the test mouth rinse, red ginseng extract containing mouth rinse is expected to have beneficial effects in reducing the disease process and thereby show a reduction in the index values as compared tto the baseline value.

 
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