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CTRI Number  CTRI/2024/05/067738 [Registered on: 21/05/2024] Trial Registered Prospectively
Last Modified On: 14/10/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A clinical study to understand the effectiveness and safety of new oral rinse in adults suffering from gingivitis. 
Scientific Title of Study   A single blind, single centric, randomized 3 arm parallel study to demonstrate the efficacy and tolerability of Gurunanda Natural Oil Pulling Oral Rinse in the management of Gum Health and Gingivitis when compared to Chlorhexidine and Placebo. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
GN_SCRS_GNOPOR02_2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashwin Prabhu 
Designation  Principal Investigator 
Affiliation   
Address  Rajalakshmi Hospital and Research Center. Department of Dental Science, Ground Floor, Room Number-3, No.21/1, Lakshmipura Main Road, Vidyaranyapura Post.

Bangalore
KARNATAKA
560097
India 
Phone  9845011615  
Fax    
Email  ashwinprabhu@dscds.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Deepa Subramanian 
Designation  CEO 
Affiliation  Syncretic Clinical Research Services Pvt. Ltd. 
Address  Syncretic Clinical Research services Pvt, Ltd, Department of Clinical Operation, Manidweep, 3rd Floor, C-2, No.13, Dynasty Layout Mariannapalya, H.A. Farm (post), Hebbal

Bangalore
KARNATAKA
560024
India 
Phone  9972598010  
Fax    
Email  deepa@syncretic.in  
 
Details of Contact Person
Public Query  
Name  Dr Deepa Subramanian 
Designation  CEO 
Affiliation  Syncretic Clinical Research Services Pvt. Ltd. 
Address  Syncretic Clinical Research Services Pvt. Ltd. Department of Clinical Operations, Manidweep, 3rd Floor, C-2, No.13, Dynasty Layout Mariannapalya, H.A. Farm (post), Hebbal

Bangalore
KARNATAKA
560024
India 
Phone  9972598010  
Fax    
Email  deepa@syncretic.in  
 
Source of Monetary or Material Support  
GURUNANDA, 6645 Caballero Blvd, Buena Park, CA 90620 
 
Primary Sponsor  
Name  GURUNANDA 
Address  6645 Caballero Blvd, Buena Park, CA 90620 
Type of Sponsor  Other [Manufacturer, Limited Company] 
 
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 Ashwin Prabhu  Rajalakshmi Hospital  Department of Dental Science, Room number-3, No.21/1., Lakshmipura Main Road, Vidyaranyapura Post
Bangalore
KARNATAKA 		 9845011615

ashwinprabhu@dscds.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Rajalakshmi Hospital Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B954||Other streptococcus as the cause of diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Chlorhexidine  Chlorhexidine to be administered orally 15 ml twice a day for 8 weeks. 
Intervention  Gurunanda Natural Oil Pulling Oral Rinse a  Gurunanda Natural Oil Pulling Oral Rinse 10 ml to be administered orally once a day for 8 weeks 
Comparator Agent  Placebo   10 ml to be administered orally once a day for 8 week 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Adult male or female subjects (age 18-60yrs)
2.Subjects with at least 24 teeth.
3.Subjects having gingival probing depth of less than 3mm.
4.Subjects having gingival index scores equal to 2 and in more than 10% of the sites.
5.Subjects having plaque index scores equals to 2 and in more than 10% of the sites.
6.Subjects with no history of hypersensitivity reactions.
7. Able to communicate adequately with the investigator and to comply with the requirements for the entire study.
8. Subjects should not have history of periodontal therapy one month prior to screening.
9. Patient should be able to give written informed consent prior to participating in the study. 
 
ExclusionCriteria 
Details  Subjects who have used antibiotics, antimicrobials, steroidal anti- inflammatory drugs, desensitizing toothpaste and NSAIDs within one month prior to screening.
2. Concomitant diseases (i.e. cancer, kidney diseases, liver diseases, neurological diseases, psychiatric diseases, blood disorders, gastrointestinal diseases).
3. Subjects with systemic conditions like diabetes, gastritis; oral diseases such as advanced periodontitis, frank dental caries, mucosal lesions.
4. Subjects with history of smoking or chewing tobacco.
5. Subjects with orthodontic appliances.
6. Hypersensitivity to any components of the investigational product.
7. Pregnancy and breastfeeding women.
8. Participation in concomitant interventional clinical study during the previous 30 days. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pharmacy-controlled Randomization 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Reduction of Modified gingival Index.
2. Reduction of Plaque Index.  		 screening week 4, 8 
 
Secondary Outcome  
Outcome  TimePoints 
1.Reduction of cariogenic oral microflora.
2.In achieveing a significant reduction in CFUs in gram positive.
3.In achieveing a significant reduction in CFUs in gram negative.
4.Improvement of clinical oral dryness score (CODS).
5.Enhancement of organoleptic scoring scale (OSS).
6.Improvement VITA shade scale.
7.Compliance and tolerability.
8.Overall treatment satisfaction questionnaire. 		 Baseline week 4, 8 
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
Final Enrollment numbers achieved (Total)= "66"
Final Enrollment numbers achieved (India)="66" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)
Modification(s)  		 12/07/2024 
Date of Study Completion (India) 01/10/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   Randomized, single blind, 3 arm and placebo controlled study to assess the effectiveness and safety of active when compared to comparator and placebo. This is a single centre study. This study is planned to be conducted in a clinical site the EC of the institution is registered with CDSCO. Study will start only after receiving the CTRI registration number.

The study population is patients diagnosed with Gingivitis. Only after all the inclusion exclusion criteria is met the subjects will be recruited into the study. Subject population is 66.

66 subjects will be divided into 3 groups each having 22 subjects in a group - active, comparator and placebo. The duration of the study will be for 56 day. 
 
The study outcome will be improvement of gingival and plaque index. Reduction of carcinigenic oral microflora. Significant reduction in CFUs in gram positive and negative microbes. Improvement of oral dryness scoring score and teeth shade. Enhancement of organoleptic score. There will be 4 visits - screening, baseline, week 4 and week 8. 

Study design: Randomized, single blind, 3 arm and placebo controlled. 


 
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