| CTRI Number |
CTRI/2025/05/086539 [Registered on: 07/05/2025] Trial Registered Prospectively |
| Last Modified On: |
23/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A Comparatitive Clinical Study To Evaluate The Effect Of Tila taila Gargling And Tilakalkodaka Gargling In The Management Of Dentin Hypersensitivity |
|
Scientific Title of Study
|
An open label double arm study to evaluate the efficacy Of Tila Taila Gandusha And Tilakalkodaka Gandusha In The Management Of Danta Harsha Wsr To Dentin Hypersensitivity |
| 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 DEEPA S |
| Designation |
POST GRADUATE SCHOLAR |
| Affiliation |
Sri Kalabyraveshwara Swamy Ayurvedic medical college hospital and research centre |
| Address |
Room number- 21 Department Of Shalakya Tantra Room Number 21
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Centre Vijayanagar Bangalore Karnataka India 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
9060529944 |
| Fax |
|
| Email |
deepavasan47@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujathamma K |
| Designation |
Professor |
| Affiliation |
Sri Kalabyraveshwara Swamy Ayurvedic medical college hospital and research centre |
| Address |
Room number 21 Dept Of Shalakya Tantra Department Of Shalakya Tantra Room Number 21
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Centre Vijayanagar Bangalore Karnataka India 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
9448848786 |
| Fax |
|
| Email |
sujathamma0531@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujathamma K |
| Designation |
Professor |
| Affiliation |
Sri Kalabyraveshwara Swamy Ayurvedic medical college hospital and research centre |
| Address |
Room num 21 Dept of Shaylakya Tantra Department Of Shalakya Tantra Room Number 21
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Centre Vijayanagar Bangalore Karnataka India 560104
Bangalore
KARNATAKA
560104
India |
| Phone |
9448848786 |
| Fax |
|
| Email |
sujathamma0531@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Shalakya Tantra Room Number 21
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Centre Vijayanagar Bangalore Karnataka India 560104 |
|
|
Primary Sponsor
|
| Name |
Dr Deepa S |
| Address |
Department Of Shalakya Tantra Room Number 21
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Centre Vijayanagar Bangalore Karnataka India 560104 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| nil |
not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr kiran M Goud |
Sri Kalabyraveshwara Ayurveda medical college hospital and research centre |
Department Of Shalakya Tantra Room Number 21
Sri Kalabyraveshwara Swamy Ayurvedic Medical College Hospital And Research Centre Vijayanagar Bangalore Karnataka India 560104
Bangalore
KARNATAKA |
9845109556
kiranmgoud@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sri kalabyraveshwara swamy ayurvedic medical college hospital and research centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K089||Disorder of teeth and supporting structures, unspecified. Ayurveda Condition: DANTAHARSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | gaNDUShaH, गण्डूषः | (Procedure Reference: sharangadhara samhitha, Procedure details: It is a process of holding medicated liquid in the mouth to its full capacity without any movement inside )
(1) Medicine Name: tilakalkodaka, Reference: sharangadhara, Route: Oral, Dosage Form: Swaras/ Juice, Dose: 30(ml), Frequency: bd, Duration: 14 Days | | 2 | Comparator Arm | Procedure | - | gaNDUShaH, गण्डूषः | (Procedure Reference: sharangadhara samhitha, Procedure details: It is a process of holding medicated liquid in the mouth to its full capacity without any movement inside )
(1) Medicine Name: tila taila, Reference: sushrutha samhitha, Route: Oral, Dosage Form: Taila, Dose: 30(ml), Frequency: bd, Duration: 14 Days |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with clinical features of Dantaharsha
Patients of either gender within the age group of 20-60 years
Uncomplicated Dental Caries
Pulpitis
Tooth wear with Attrition Abrasion Erosion in moderate to severe form
|
|
| ExclusionCriteria |
| Details |
Traumatic conditions of oral cavity like cracked tooth
Any acute infective condition of oral cavity like periodontal diseases such as periodontitis
Carcinomatous conditions of oral cavity
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To see the rate of reduction in hypersensitivity using cold air blast test percussion test and other Parameters in treatment modalities gargling in Dental hypersensitivity |
total duration of study is 28 days 14 days of gargling and 14 days of follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
07/05/2025 |
| 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="5" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
These treatment
procedures are cost effective and non invasive and in modern medicine the
reocurrance of the symptoms of dentin hypersensitivity is more once the
desensitizing agents are ceased Hence the present study is undertaken to
evaluate to the effect of Tila taila gandusha and Tilakalkodaka gandusha in the management of
Danta Harsha |