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CTRI Number  CTRI/2018/02/012165 [Registered on: 26/02/2018] Trial Registered Retrospectively
Last Modified On: 21/02/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Diagnostic
Preventive
Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of Triphaladi mouthwash in patients of dental caries. 
Scientific Title of Study   Clinical evaluation of an Ayurvedic formulation- Triphaladi Gandusha for its Krimidanta Pratishedha (anti-caries) activity in High Risk Dental Caries patients. 
Trial Acronym  - 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Achyuta 
Designation  Lecturer 
Affiliation  Ph.D. Ayu 
Address  Department of Shalakya Tantra Shree Gulabkunverba Ayurved Mahavidyalaya Gujarat Ayurved University Jamnagar
Department of Shalakya Tantra Shree Gulabkunverba Ayurved Mahavidyalaya Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
361 008
India 
Phone  9828828814  
Fax    
Email  achyutaa250@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Manjusha Rajgopala 
Designation  Professor & HOD 
Affiliation  Ph.D. (Ayu)  
Address  Department of Shalakya Tantra All India Institute of Ayurveda, Gautampuri New Delhi-110076
Department of Shalakya Tantra All India Institute of Ayurveda, Gautampuri New Delhi-110076
New Delhi
DELHI
110076
India 
Phone  7600901848  
Fax    
Email  bhatrajma2008@gmail.com  
 
Details of Contact Person
Public Query  
Name  Achyuta 
Designation  Lecturer 
Affiliation  Ph.D.(Ayu) 
Address  Department of Shalakya Tantra Shree Gulabkunverba Ayurved Mahavidyalaya Gujarat Ayurved University Jamnagar
Department of Shalakya Tantra Shree Gulabkunverba Ayurved Mahavidyalaya Gujarat Ayurved University Jamnagar
Jamnagar
GUJARAT
361 008
India 
Phone  9828828814  
Fax    
Email  achyutaa250@gmail.com  
 
Source of Monetary or Material Support  
Department of AYUSH New Delhi 
 
Primary Sponsor  
Name  IPGT and RA 
Address  opp reliance super Jamnagar  
Type of Sponsor  Research institution and hospital 
 
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 
Achyuta Atara  Hospital IPGT and RA  IPGT and RA Opp Reliance Super Jamnagar
Jamnagar
GUJARAT 		 9824424414

achyutaa250@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  dental caries with blackish discolouration and cavity formation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Triphaladi Gandusha  Group-2 patients in this group were received (Triphaladi Gandusha) 
Intervention  Triphaladi Mouthwash   1. Drug preparation It was prepared by two methods Method-1 An aqueous solution was prepared on the basis of method described in the study done at Rajah Muthiah Dental College and Hospital, Annamalai University, Tamilnadu. Method-2:- An aqueous solution was prepared on the basis of classical method of Gandusha preparation.(i.e. Coarse powder of drugs will be mixed with 16 times water & water was evaporated till ¼ remains. Then it was filtered and given luke warm to the patient for Gandusha). 2. Method: The patients were asked to rinse or retain the Gandusha in the mouth. Retention time differ according to method of preparing aqueous solution. Retention time for the patients receiving solution made by method-1 was 40 seconds and for the patients receiving solution made by method-2 was till features of Samyaka Gandusah appear (i.e. till the cheeks show signs of kapha accumulation and exudation appear in the nostrils & eyes) before expectorating it. Average time for Gandusha dharana was 8 minutes.  
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  High risk patients of dental caries (Hereditary susceptible along with patients having more than 3 DMF index and the patients in the age group 5 to 40 years of lowered pH & buffering capacity along with microbial load in salivary samples) were included in this study. 
 
ExclusionCriteria 
Details  Patients of chronic debilitating diseases, diabetes mellitus, endocrine dysfunction, pregnant women, age group below 5 & above 40 etc. were excluded from the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Triphaladi Gandusha Retention was provided better results in Ruja Dantaharsha Sarambha pH microbial count. And Triphaladi Gandusha Mouthrinse was provided better results in Srava Bad Breath pH and Buffering capacity.  Result was assesses after completion of one month treatment. 
 
Secondary Outcome  
Outcome  TimePoints 
rather than just  upto present study 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   28/02/2011 
Date of Study Completion (India) 28/12/2011 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="1"
Days="30" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

·                     From the results and observation which were received from this study it can be summarized that Triphalādi Gandūşa Retention was provided better results in Rujā DantaharÅŸa Sarambha pH microbial count. And Triphalādi Gandūşa Mouthrinse was provided better results in Srāva Bad Breath pH and Buffering capacity.

·                     Further it can be summarized that there is no improvement in Chidratā- cavity formation, KÅ—Å›natā- discoloration and Caladanta – mobility with Triphalādi Gandūşa.

·                     Pain and sensitivity was observed in follow up period in both the groups. This shows that this treatment does only give relief for time being  pulpitis recurs unless cavity is not treated. Once cavity or lesion formed is irreversible.

·                     It is difficult to completely eliminate the interfering factors affecting the objective parameters of saliva samples that are collected in a dental practice setting.

 
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