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CTRI Number  CTRI/2022/02/040379 [Registered on: 17/02/2022] Trial Registered Prospectively
Last Modified On: 15/02/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Single Arm Study 
Public Title of Study   Safety & Efficacy of HDNT-072012 
Scientific Title of Study   An Open label, Clinical Study to Evaluate the Oral Mucosal Safety & Efficacy of HDNT-072012 in Healthy Adult Subjects 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
HWC/MSCD/CPD/047/2021 Version: 1.0, Dated: 08 Dec 2021  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Suhas Prabhakar 
Designation  BDS, MD 
Affiliation  Private Clinic 
Address  Trilkamal Dental Clinic, no.46, Park area, 10thCross, Wilson Garden, Bangalore

Bangalore
KARNATAKA
560027
India 
Phone  9739325771  
Fax    
Email  suhasprabs.y2k@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Swathi B 
Designation  Clinical Team Lead  
Affiliation  Himalaya Wellness Company 
Address  clinical pharmacology, R and D, Makali, bengaluru
Makali
Bangalore Rural
KARNATAKA
562162
India 
Phone  8067547232  
Fax    
Email  dr.swathi.b@himalayawellness.com  
 
Details of Contact Person
Public Query  
Name  Dr Soorya Narayan H 
Designation  Manager Clinical Operations 
Affiliation  Himalaya Wellness Company 
Address  clinical pharmacology, R and D, Makali, bengaluru
Makali
Bangalore Rural
KARNATAKA
562162
India 
Phone  8067549919  
Fax    
Email  dr.sooryanarayan.h@himalayawellness.com  
 
Source of Monetary or Material Support  
Himalaya Wellness Company 
 
Primary Sponsor  
Name  Himalaya Wellness Company  
Address  Tumkur road, Makali Bangalore India, Bangalore 562162  
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 Suhas Prabhakar  Trilkamal Dental Clinic  #46, Park area, 10th Cross, Wilson Garden, Bangalore-560027
Bangalore
KARNATAKA 		 9739325771

suhasprabs.y2k@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACE Independent Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Adult Subjects 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: HDNT-072012 , Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1(NA), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
(2) Medicine Name: 6 Weeks, Reference: NA, Route: , Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
(3) Medicine Name: 6 Weeks, Reference: NA, Route: , Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Subjects with age group 18 years to 60 years in general good health and oral health.
2.Subjects willing to provide consent to the study
3.Subjects with moderate oral hygiene and adhering to basic habits like using standard toothbrush and toothpaste
4.No history of any clinically significant medical condition
5.No recent history (past 3 months) of overall oral/gum bleeding disorders
6.No history of any medical problems requiring hospital care.
7.Willing to abide by and comply with the study protocol.
8.Available to comply the study procedure for the entire duration of the study.
9.Should not have participated in a similar clinical study in the past four weeks and who are willing not to participate in any other clinical study during participation in the current study.
 
 
ExclusionCriteria 
Details  1.A known history or present condition of hyper sensitivity to any test product.
2.No oral substance abuse such as current use or recent history of tobacco, pan, gutka, cigarette
3.Pregnant and lactating subjects
4.The use of antibiotic, antimicrobial, analgesic medications, desensitizing test product during the previous 1 month.
5.Any history of periodontal therapy by surgical interventions.
6.Any history of dentine hypersensitivity treatment.
7.Any removable device such as a removable partial denture or orthodontic retainer.
8.The presence of any large or defective restorations, cracked enamel, or caries on the History hypersensitive tooth.
9.Having intrinsic dental stains.
10.Having abnormal frenum attachment.
11.Having moderate to severe level of calculus and/ tartar.
12.Any underlying uncontrolled medical illness including diabetes mellitus, hypertension, liver disease or history of currently using any medication or expects to be on any medication which in the opinion of the investigator, may affect the evaluation of the test product, or place the subject at undue risk.
13.Suffering from any form of systemic illness, oral infections, hospitalizations and pharmacological treatment.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To determine the efficacy of test product in
preventing plaque build-up evaluated through plaque index, improving gum health evaluated through Gingival index by dentist, teeth whitening effect of test product as evaluated by VITA shade card
 		 1.Screening and baseline visit(day1)
2.Visit 2(Day 15)
3.Visit 3(Day 45)/End of study visit 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluation of preventing mouth odour, providing of Mouth freshness, maintain clean and healthy mouth, providing Long lasting fresh breath through subjective questionnaire, safety of test product by buccal irritation score and subject reported adverse events  1.Screening and baseline visit(day1)
2.Visit 2(Day 15)
3.Visit 3(Day 45)/End of study visit 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   02/03/2022 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

This is a prospective, open label, clinical study to evaluate the oral mucosal safety and efficacy of test product in 40 healthy adult subjects. The subjects were asked to make use of the test product for 6 weeks. 

The following clinical assessments will be carried out by the Investigator

The clinical efficacy assessment will be carried out through:

  1. Plaque index
  2. VITA Shade
  3. Gingival index
  4. Subjective questionnaire

Safety assessment:

  1. Buccal irritation scoring as safety parameter
  2. Adverse event reporting
These assessments could be used to evaluate the oral hygene of the the participants before and after the study thus proving the safety and efficacy of the test product. 

 
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