| CTRI Number |
CTRI/2025/09/095315 [Registered on: 23/09/2025] Trial Registered Prospectively |
| Last Modified On: |
23/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Use of Sida Rhombifolia (Kurunthotti) In Management Of Temporomandibular Joint Disorders |
|
Scientific Title of Study
|
Comparison Of the Efficacy Of Topical Sida Rhombifolia Extract And Topical Diclofenac Sodium In Management Of Temporomandibular Joint Pain Disorders: A Double Blinded Randomized Controlled 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 |
Yesoda Aniyan K |
| Designation |
Associate professor |
| Affiliation |
SRM Dental College, Ramapuram |
| Address |
Department of Oral Medicine and Radiology, SRM Dental College, Ramapuram, Bharathi Salai, Chennai
Chennai
TAMIL NADU
600089
India |
| Phone |
8892573591 |
| Fax |
|
| Email |
yesoda.aniyan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anuradha G |
| Designation |
Professor and Head of the Department |
| Affiliation |
SRM Dental College, Ramapuram |
| Address |
Department of Oral Medicine and Radiology, SRM Dental College, Ramapuram, Bharathi Salai, Chennai
Department of Oral Medicine and Radiology, SRM Dental College, Ramapuram, Bharathi Salai, Chennai
Chennai
TAMIL NADU
600089
India |
| Phone |
|
| Fax |
|
| Email |
anuradhg@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Yesoda Aniyan K |
| Designation |
Associate professor |
| Affiliation |
SRM Dental College, Ramapuram |
| Address |
Department of Oral Medicine and Radiology, SRM Dental College, Ramapuram, Bharathi Salai, Chennai
Chennai
TAMIL NADU
600089
India |
| Phone |
8892573591 |
| Fax |
|
| Email |
yesoda.aniyan@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Yesoda Aniyan K |
| Address |
Department of Oral Medicine and Radiology, SRM Dental College, Ramapuram, Bharathi Salai, Chennai, Tamil Nadu, 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 |
| Yesoda Aniyan K |
SRM Dental College |
Department of Oral Medicine and Radiology, SRM Dental College, Ramapuram, Bharathi Salai, Chennai
Chennai
TAMIL NADU |
08892573591
yesoda.aniyan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board of SRM Dental College, Ramapuram |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M12||Other and unspecified arthropathy, (2) ICD-10 Condition:M20-M25||Other joint disorders. Ayurveda Condition: HANUGRAHAH/HANUSRAMSA, (3) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | Drug | Other than Classical | | (1) Medicine Name: Diclofenac sodium, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 3 Weeks, anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm (Non Ayurveda) | Drug | - | | | | 3 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Sida Rhombifolia extract, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 1(g), Frequency: tds, Bhaishajya Kal: Abhakta, Duration: 3 Weeks, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who are willing for the study
2.Patients above 18 years of age
3.Patients with TMD with or without masticatory muscle pain under RDC criteria are included.
4. Patients with symptoms of pain along with clicking, crepitus,deviation during jaw movement, pain and difficulty in opening the mouth, pain in pre auricular area, and spreading to surrounding areas.
|
|
| ExclusionCriteria |
| Details |
1. Patients under 18 years of age
2. Pregnant and lactating patients
3. Physically challenged and mentally retarded persons
4. Patients with previous history of TMD and underwent treatment for it or on going currently.
5. Patients with clear history of swelling, trauma,fracture,intolerable pain in temporomandibular joint
6. Subjects with history of allergy to the drug components.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To alleviate the pain associated with Temporomandibular joint disorders |
Evaluate at 7,14,21 1nd 28days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Efficacy of Sida Rhomifolia extract medicament in comparison to standard topical diclofenac sodium in pain management |
0,7,14,21 and 28 days. |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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)
|
04/10/2025 |
| 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
|
| To assess the phytochemical components and investigations for medicament preparation. To determine the efficacy of topical Sida cordifolia in TMD using Numerical Rating Scale in pain management. To compare the effectiveness of topical SC with topical Diclofenac Sodium in patients with TMD with or without associated masticatory muscle pain. The primary objective of the study | To evaluate the comparative efficacy of topical Sida cordifolia root extract to topical diclofenac sodium in the management of TMD disorders associated masticatory muscle pain | | |