| CTRI Number |
CTRI/2025/04/084100 [Registered on: 04/04/2025] Trial Registered Prospectively |
| Last Modified On: |
02/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Til Tail Swishing in mouth in Dantharsha ( Dental hypersensitivity) |
|
Scientific Title of Study
|
A Randomised Controlled Clinical Trial to study the effect of Til taila kaval in the management of Dantaharsha with special reference to Dental 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 Akshay Balu Pagare |
| Designation |
Post Graduate Student |
| Affiliation |
SMBT Ayurved College and Hospital, Dhamangaon, Igatpuri, Nashik 422403 |
| Address |
OPD No 16 ,Department of Shalakyatantra,SMBT Ayurved College and Hospital,Dhamangaon,Igatpuri, Nashik 422403 Maharashtra, India
Nashik
MAHARASHTRA
422403
India |
| Phone |
8888893013 |
| Fax |
|
| Email |
pagare917@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tushar Vishnu Firke |
| Designation |
Professor and Head of Department |
| Affiliation |
SMBT Ayurved College and Hospital, Dhamangaon, Igatpuri, Nashik 422403 |
| Address |
OPD No 16 ,Department of Shalakyatantra,SMBT Ayurved College and Hospital,Dhamangaon,Igatpuri, Nashik 422403 Maharashtra, India
Nashik
MAHARASHTRA
422403
India |
| Phone |
9823388720 |
| Fax |
|
| Email |
dr.tusharfirke@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akshay Balu Pagare |
| Designation |
Post Graduate Student |
| Affiliation |
SMBT Ayurved College and Hospital, Dhamangaon, Igatpuri, Nashik 422403 |
| Address |
OPD No 16,Department of Shalakyatantra,SMBT Ayurved College and Hospital,Dhamangaon,Igatpuri, Nashik 422403 Maharashtra, India
Nashik
MAHARASHTRA
422403
India |
| Phone |
8888893013 |
| Fax |
|
| Email |
pagare917@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Shalakyatantra,SMBT Ayurved College and Hospital, Dhamangaon, Igatpuri, Nashik 422403 |
|
|
Primary Sponsor
|
| Name |
Dr.Akshay Balu Pagare |
| Address |
SMBT Ayurved College and Hospital, Dhamangaon, Igatpuri, Nashik 422403, Maharashtra, India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Akshay Balu Pagare |
SMBT Ayurved College and Hospital |
OPD No 16, Department of Shalakyatantra,SMBT Ayurved College and Hospital, Dhamangaon, Igatpuri, Nashik 422403, Maharashtra, India
Nashik
MAHARASHTRA |
8888893013
pagare917@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMBT Ayurved College and Hospital, Dhamangaon, Igatpuri |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K088||Other specified disorders of teethand supporting structures. Ayurveda Condition: DANTAHARSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | gaNDUShaH, गण्डूषः | (Procedure Reference: , Procedure details: Tila taila gandusha)
| | 2 | Intervention Arm | Procedure | - | kavalaH, कवलः | (Procedure Reference: सु.चि.४०/६२, Procedure details: 20ml Til tail Kavala OD for 7 days.)
|
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1)Ptient having age between 20-40 years and irrespective of
socioeconomic status, sex & religion.
2)Patient having sign and symptoms of dantaharsha mentioned in
ayurvedic classics like pain, discomfort in the teeth, sensitivity to teeth
as responses to certain stimuli such as hot and cold temperature.
3)Patient who will give written consent. |
|
| ExclusionCriteria |
| Details |
1)Bleeding disorder.
2)Chronic carcinogen ulceration in oral cavity.
3)Person suffering from DM, TB, HIV, HbsAg positive. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of til taila kaval in the management of dantaharsha based on the assessment criteria before and after. |
7 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Where the trial group stands in comparison with control group in reduction in signs and symptoms of dantaharsh. |
18 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 2 |
|
Date of First Enrollment (India)
|
17/04/2025 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Dantaharsha defined as a dental disease, with pain in tooth and hypersensitivity. Kaval or swishing of oil in mouth helps particles,and other debris. The prevalence rate of dental hypersensitivity is 32%. Til tail kaval has been selected. Til (sesame seed ) is high in protein, vitamin B1, iron, calcium, phosphorus which help to strengthen the teeth and calcium makes it more stronger. Age group 20 to 40 years. The number of patient will be selected and divided into 2 groups named Group A (trail) Group B (controlled) Til tail kaval (trail)& Til tail gandoosh (controlled) Both the drug’s will be admistered for 15 days observation done day 0, day 3 , day 5,day 7 & day 15
Summary will be drawn and whole thesis will be summarised Conclusion will be drawn strictly on the basis of statistical Analysis and will be unbiased. |