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CTRI Number  CTRI/2022/12/047942 [Registered on: 07/12/2022] Trial Registered Prospectively
Last Modified On: 05/12/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Other 
Public Title of Study   A clinical trial to study effect of Katphal deccoction gargles and Triphaladi deccoction gargles in management of dental caries 
Scientific Title of Study   Randomised controlled clinical trial to compare efficacy of Katphal kwath gandush and Triphaladi kwath gandush in management of Krimidant 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rasika Ladke 
Designation  MS Scholar Shalakya Tantra  
Affiliation  Tilak Ayurved Mahavidyalaya Pune  
Address  Department of Shalakyatantra 3rd floor Tilak Ayurved Mahavidyalaya 583/2 Rasta Peth Pune

Pune
MAHARASHTRA
411011
India 
Phone  7058531036  
Fax    
Email  rasika.ladke@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prakash Guddimath 
Designation  PG Guide Associate Professor Shalakya Tantra Department 
Affiliation  Tilak Ayurved Mahavidyalaya Pune 
Address  Department of Shalakyatantra 3rd floor Tilak Ayurved Mahavidyalaya 583/2 Rasta Peth Pune

Pune
MAHARASHTRA
411011
India 
Phone  9527545122  
Fax    
Email  drprakashig@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rasika Ladke 
Designation  PG Scholar Shalakya Tantra 
Affiliation  Tilak Ayurved Mahavidyalaya 
Address  Department of Shalakyatantra 3rd floor Tilak Ayurved Mahavidyalaya 583/2 Rasta peth Pune

Pune
MAHARASHTRA
411011
India 
Phone  7058531036  
Fax    
Email  rasika.ladke@gmail.com  
 
Source of Monetary or Material Support  
Daily OPD Patient Sheth Tarachand Ramnath charitable Ayurvedic Hospital PUNE 
 
Primary Sponsor  
Name  Tilak Ayurved Mahavidyalay Pune 
Address  Tilak Ayurved Mahavidyalaya 583/2 Rasta Peth Pune 411011 
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 Rasika Ladke  Sheth Tarachand Ramnath Charitable Ayurved Hospital  Department Of Shalakyatantra OPD No 15 First Floor Rasta Peth Pune
Pune
MAHARASHTRA 		 7058531036

rasika.ladke@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committe  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: Krimidant, (2) ICD-10 Condition:K029||Dental caries, unspecified. Ayurveda Condition: KRUMIDANTAKAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-Gandush, गण्डूषः (Procedure Reference: Ashtanghridaya, Procedure details: Gandush is a procedure of holding liquid drug in a mouth with complete restriction of movements inside)
(1) Medicine Name: Triphala Putiha Kankshi, Reference: Dravyaguna, Route: Oral, Dosage Form: Churna/ Powder, Dose: 40(mg), Frequency: bd, Duration: 7 Days
2Intervention ArmProcedure-Gandush, गण्डूषः (Procedure Reference: Ashtanghridaya, Procedure details: Gandush is a procedure of holding liquid drug in a mouth with complete restriction of movements inside)
(1) Medicine Name: Katphal, Reference: Dravyaguna, Route: Oral, Dosage Form: Churna/ Powder, Dose: 40(mg), Frequency: bd, Duration: 7 Days
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients having signs and symptoms of krimidant  
 
ExclusionCriteria 
Details  Patients having other disease of oral cavity, 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 
Sample size 70 decrease in pain, swelling  6 Months 
 
Secondary Outcome  
Outcome  TimePoints 
Decrease in symptoms like pain, swelling  3 Months 
 
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 3 
Date of First Enrollment (India)   10/12/2022 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None Yet 
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 Katphal Kwath Gandush and Triphaladi Kwath Gandush to Group A & Group B respectively. The efficacy of the therapy will be assessed on the basis of subjective criteria for statistical analysis. scoring will be designed according to the severity of symptoms.
The subjective 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 results will be Assess in regards to the clinical sign and symptoms on the basis of grading and scoring system. The signs and symptoms will be Assess by adopting the suitable scoring method
 
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