| CTRI Number |
CTRI/2026/04/108586 [Registered on: 17/04/2026] Trial Registered Prospectively |
| Last Modified On: |
06/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of a Herbal Gel in Managing Jaw Pain: A Clinical Study |
|
Scientific Title of Study
|
Assessment of therapeutic effectiveness of Arnica and Chamomile gel in managing painful Temporomandibular Disorders - A Randomised Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sharuniveda S |
| Designation |
Postgraduate |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
No 169, Saveetha Dental College and Hospital , Poonamalle High road , Velappanchavadi , Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
8072174468 |
| Fax |
|
| Email |
sharuniveda14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Umamaheswari TN |
| Designation |
Head of the Department |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
No 169, Saveetha Dental College and Hospital , Poonamalle High road , Velappanchavadi , Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9840958339 |
| Fax |
|
| Email |
umamaheswaritn@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Sharuniveda S |
| Designation |
Postgraduate |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
No 169, Saveetha Dental College and Hospital , Poonamalle High road , Velappanchavadi , Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
8072174468 |
| Fax |
|
| Email |
sharuniveda14@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College and Hospitals , SIMATS , Chennai ,Tamilnadu |
|
|
Primary Sponsor
|
| Name |
Institution |
| Address |
Saveetha Dental College and Hospital , No 169 , Poonamalle High road Velappanchavadi , Chennai , Tamilnadu - 600077 |
| Type of Sponsor |
Private medical college |
|
|
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 Sharuniveda S |
Department of Oral medicine and radiology.Saveetha Dental College and Hospitals . |
Clinic 20 , Department of Oral Medicine and Radiology ,Saveetha Dental College and Hospital ,No 169, Poonamalle High road , Velappanchavadi , Chennai
Chennai
TAMIL NADU |
08072174468
sharuniveda14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDC-IHEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Arnica montana and Chamomilla recutita gel |
The formulated herbal gel is instructed to apply over the affected area twice daily for 30 days |
| Comparator Agent |
Diclofenac gel |
The diclofenac gel is instructed to apply over the affected area twice daily for 30 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Myogenous Disorders
Disc displacement with reduction
Disc displacement without reduction
Capsulitis
Synovitis |
|
| ExclusionCriteria |
| Details |
Developemntal diosrders
Degenerative disorders
Mobility disorders of TMJ
Patients who underwent previous treatment for TMDs Patients who are allergic to Arnica Chamomile and Diclofenac
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in pain |
Baseline , 15th day , 30th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of pain relief , improvement in mandibular movements after Arnica-Chamomile gel therapy , Evaluating improvement in Quality of life of the patient |
Baseline , 15th day , 30 th day |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
23/04/2026 |
| 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="0"
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
|
This randomised clinical trial aims to evaluate the therapeutic effectiveness of a topical herbal gel containg Arnica montana and Chamomilla recutita in the management of painful temporomandibular disorders . Participants diagnosed with painful temporomandibular disorders will be randomly allocated into two groups and treated with either th herbal gel or a standard topical topical medication Clinical parameters including pain intensity , mouth opening and muscle tenderness will be assesses at baseline and follow up visits to determine the effectiveness of the intervention. |