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CTRI Number  CTRI/2025/07/090014 [Registered on: 02/07/2025] Trial Registered Prospectively
Last Modified On: 30/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Comparative Clinical Study on the Effectiveness of Kantakari kwath mouth rinse and Triphaladi Kwath mouth rinse in the Treatment of Dental Caries in age group 18-50 years 
Scientific Title of Study   Randomized controlled clinical trial to compare efficacy of kantakari kwath gandush and triphaladi kwath gandush in the management of krimidant. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prajakta Prabhakar Ingale  
Designation  PG Scholar 
Affiliation  Tilak Ayurved Mahavidyalaya pune 
Address  Department of Shalakyatantra Tilak Ayurved Mahavidyalaya pune

Pune
MAHARASHTRA
411011
India 
Phone  7391961956  
Fax    
Email  prajaktaingale789@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sangeeta Santosh Salvi 
Designation  Head of Department 
Affiliation  Tilak Ayurved Mahavidyalaya pune 
Address  Department of Shalakyatantra Tilak Ayurved Mahavidyalaya pune

Pune
MAHARASHTRA
411011
India 
Phone  09822082795  
Fax    
Email  salvisangeeta@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Sangeeta santosh Salvi 
Designation  Head of department 
Affiliation  Tilak Ayurved Mahavidyalaya pune 
Address  Department of Shalakyatantra Tilak Ayurved Mahavidyalaya pune

Pune
MAHARASHTRA
411011
India 
Phone  09822082795  
Fax    
Email  salvisangeeta@yahoo.co.in  
 
Source of Monetary or Material Support  
Seth Tarachand Ramnath Charitable Ayurvedic Hospital, 580/2 Rasta Peth, Pune, 411011, Maharashtra, India. 
 
Primary Sponsor  
Name  TILAK AYURVED MAHAVIDYALAYA 
Address  Tilak Ayurved Mahavidyalaya, 2nd floor, shalakyatantra department, Rastapeth, 583/2, Pune 411011. Pune MAHARASHTRA 
Type of Sponsor  Private medical college 
 
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 Prajakta Ingale  Seth Tarachand Ramnath Ayurvedic Hospital Pune  Tilak Ayurved Mahavidyalaya, 2nd floor, Shalakyatantra department, Rastapeth, 583/2, Pune 411011. Pune MAHARASHTRA Pune MAHARASHTRA Pune MAHARASHTRA
Pune
MAHARASHTRA 		 07391961956

prajaktaingale789@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional ethical committe, TAMV pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K029||Dental caries, unspecified. Ayurveda Condition: KRUMIDANTAKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Kantakari Kwatha, Reference: Bhaishajyaratnavali .chikitsasthana 61th adhyaya Mukharogachikitsa adhyaya Shlok number 41, Route: Topical, Dosage Form: Kwatha/ Kashaya, Dose: 80(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator ArmDrugOther than Classical(1) Medicine Name: Triphaladi Kwatha, Reference: NA, Route: Topical, Dosage Form: Kwatha/Kashaya, Dose: 80(ml), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 7 Days, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Participants with features of black discoloration of teeth, pain and swelling of gum.
2. Freshly infected.
3. 1 – 4 teeth infected 
 
ExclusionCriteria 
Details  1. Participants having history of other disease of oral cavity like oral malignancy, stomatitis.
2. Participant having history of fractured tooth, periodontal abscess. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
decrease in pain and discolouration  3 day 
 
Secondary Outcome  
Outcome  TimePoints 
decrease in pain , discolouration and inflammation of gums  7 day 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 2/ Phase 3 
Date of First Enrollment (India)   30/07/2025 
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="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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   The study will be intervened by the treatment of Kantakari kwatha gandusha and Triphaladi Kwatha Gandusha to group A and group B respectively. The efficacy of the therapy will be assessed on the basis of subjective and objective criteria for statistical analysis. Scoring will be designed according to the severity of symptoms. The subjective and objective gradation of symptoms will be done as follows and the intensity of each symptom will be calculated before treatment, after treatment and after follow up. The effect of treatment result will be assessed in regards to clinical signs and symptoms on the basis of grading and scoring system. The signs and symptoms will be assessed by adopting the suitable scoring method. 
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