| CTRI Number |
CTRI/2025/08/093653 [Registered on: 26/08/2025] Trial Registered Prospectively |
| Last Modified On: |
25/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Study of Narayana Taila Pratisarana in Dantaharsha With Reference to Dentinal Hypersensitivity. |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Study of Narayana Taila Pratisarana in Dantaharsha With Special Reference to Dentinal 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 Shankar Laxmanrao Indurkar |
| Designation |
PG STUDENT |
| Affiliation |
Govt Ayurved College Nanded |
| Address |
OPD No.25. ShalakyaTantra Department, Government Ayurved College And Hospital Vazirabad ,Nanded.
Nanded
MAHARASHTRA
431601
India |
| Phone |
9049810720 |
| Fax |
|
| Email |
shankar.indurkar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nisar Ali Khan |
| Designation |
HOD and Professor |
| Affiliation |
Govt Ayurved College Nanded |
| Address |
OPD No.25. ShalakyaTantra Department Government Ayurved College And Hospital Vazirzbad ,Nanded.
Nanded
MAHARASHTRA
431601
India |
| Phone |
9325607099 |
| Fax |
|
| Email |
dr.khan_na@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nisar Ali Khan |
| Designation |
HOD and Professor |
| Affiliation |
Govt Ayurved College Nanded |
| Address |
OPD No.25. ShalakyaTantra Department Government Ayurved College And Hospital Vazirabad, NANDED.
MAHARASHTRA
431601
India |
| Phone |
9325607099 |
| Fax |
|
| Email |
dr.khan_na@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Shalakyatantra Department Govt Ayurved College Vazirabad Nanded 431601 |
|
|
Primary Sponsor
|
| Name |
Dr Shankar Laxman Indurkar |
| Address |
Govt Ayurved College Vazirabad Nanded 431601 |
| 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 Shankar Laxmanrao Indurkar |
GOVERNMENT AYURVED COLLEGE AND HOSPITAL NANDED |
OPD No.25. Shalakyatantra Department Govt Ayurved College And Hospital Vazirabad, Nanded 431601.
Nanded
MAHARASHTRA |
9049810720
shankar.indurkar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee GOVT Ayurved College Nanded |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K038||Other specified diseases of hard tissues of teeth. Ayurveda Condition: DANTAHARSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 41. pratisAraNam | (Procedure Reference: 41. pratisAraNam , Procedure details: Narayana Taila 2ml is applied on teeth having sensitivity for 14 days.)
(1) Medicine Name: Narayana Taila, Reference: 41. pratisAraNam , Route: Topical, Dosage Form: Taila, Dose: 2(ml), Frequency: bd, Duration: 14 Days | | 2 | Comparator Arm | Procedure | - | 41. pratisAraNam | (Procedure Reference: 41. pratisAraNam , Procedure details: Irimedadi Taila 2ml BD is applied over teeth having sensitivity for 14 days .)
(1) Medicine Name: Irimedadi Taila, Reference: 41. pratisAraNam , Route: Topical, Dosage Form: Taila, Dose: 2(ml), Frequency: bd, Duration: 14 Days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient having symptoms of Dentinal hypersensitivity.
Patient with adequate oral hygiene. |
|
| ExclusionCriteria |
| Details |
Patient with systemic illness or with other acute diseases.
Acute inflammatory conditions of periodontal tissues or Gums.
Patients with prosthesis or orthodontic appliances.
Drug addict patients or who do not give their consent. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Decreased pain and Dentinal sensistivity. |
Before Treatment Day 0
After Treatment Day 28 |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
09/09/2025 |
| 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="2"
Months="0"
Days="0" |
|
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
|
Dentinal Hypersensitivity is very common and difficult to treat in modern science due to non effective treatment. Trial drug is Narayana Taila and control drug is Irimedadi Tail in Dentinal Hypersensitivity . Both trial and control groups are studied irrespectively. Observations and conclusions are drawn from Statistical test for significance. |