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CTRI Number  CTRI/2025/06/088268 [Registered on: 04/06/2025] Trial Registered Prospectively
Last Modified On: 23/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Dentistry 
Study Design  Single Arm Study 
Public Title of Study   Role of Tilkalkoda Gandusha in the patients having symptoms of Dantaharsha 
Scientific Title of Study   A Clinical study to evalaute the effect of Tilakalkodaka Gandusha in Dantaharsha 
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 Smita Zambare 
Designation  Professor and HOD 
Affiliation  Uttranchal Ayurvedic College Dehradun 
Address  Dept of Swasthvritta and yoga,Uttranchal Ayurvedic College Rajpur Dehradun,Uttarakhand

Dehradun
UTTARANCHAL
248001
India 
Phone  8879133317  
Fax    
Email  smitazambare1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Smita Zambare 
Designation  Professor and HOD 
Affiliation  Uttranchal Ayurvedic College Dehradun 
Address  Dept of Swasthvritta and yoga,Uttranchal Ayurvedic College Rajpur Dehradun,Uttarakhand

Dehradun
UTTARANCHAL
248001
India 
Phone  8879133317  
Fax    
Email  smitazambare1@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rahul Khali 
Designation  PG Scholar 
Affiliation  Uttranchal Ayurvedic College Dehradun 
Address  Uttranchal Ayurvedic College Rajpur Dehradun, Uttarakhand

Dehradun
UTTARANCHAL
248001
India 
Phone  7409788423  
Fax    
Email  rahulkhali84@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Uttaranchal Ayurvedic College  
Address  Uttarachal Ayurvedic College Rajpur Dehradun Uttarakhand 248001 
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 Rahul Khali  Uttaranchal Ayurvedic College Rajpur Dehradun, Uttarakhand  Swasthyarakshan OPD, Uttranchal Ayurvedic College Rajpur Dehradun
Dehradun
UTTARANCHAL 		 7409788423

rahulkhali84@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Commitee Uttaranchal Ayurvedic College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:K051||Chronic gingivitis. Ayurveda Condition: DANTAHARSHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Gandusha (Procedure Reference: Ashtang hridaya sutra sthan , Procedure details: Patients registered for the study will be provided 5 gm raw whole Tila seed packets.In the procedure patient will be advised to make paste of Tila seeds followed by adding 10 ml of water to make a fine mixture. Patient has to take the mixture to hold in the mouth for 4-6 mins(as per their holding capability) without moving it.)
(1) Medicine Name: tila kalka, Reference: ashtang hridaya sutrasthan, Route: Oral, Dosage Form: Kalka/ Paste, Dose: 15(g), Frequency: bd, Duration: 1 Months
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients having classical symptoms of Dantaharsha

Vata-asahinshnuta(intolerant to breeze)
Amla-asahinshnuta (intolerant to sour food)
sheeta-asahinshnuta (intolerant to cold stuff)
Saruja chala amlaashnena(pain and loosening of teeth followed by sour food) 
 
ExclusionCriteria 
Details  Bleeding gums, Bleeding disorder, Conjunctivitis,
Rhinitis.
Hypertension, Cardiovascular illness  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Frequency of brushing

Bleeding while brushing of teeth

Intolerance of cold water

Intolerance of breeze

Pain while eating harsh or solid form of food 		 outcome will be evaluated every 15th day for 30 days

 
 
Secondary Outcome  
Outcome  TimePoints 
improvement in sign and symptoms  after 30 days of intervention 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   25/06/2025 
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="0"
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   Selected drug -Raw seeds of Black Tila(krishna tila)/Seasamum indicum from the local pharmacy shop is taken for the study
Form of Medicine- paste
 Composition of medicine – 5 gm raw tila seeds +lukewarm water(10 ml) • Dose of medicine-15 ml (twice a day)
 Route of administration-Oral 
Procedure- Patients registered for the study will be provided 5 gm raw whole Tila seed packets.In the procedure patient will be advised to make paste of Tila seeds followed by adding 10 ml of water to make a fine mixture.
 Patient has to take the mixture to hold in the mouth for 4-6 mins(as per their holding capability) without moving it. •
 Duration of treatment- Patient has to follow this procedure twice a day(morning and evening) for 1 month


 
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