| CTRI Number |
CTRI/2026/04/108889 [Registered on: 21/04/2026] Trial Registered Prospectively |
| Last Modified On: |
20/04/2026 |
| 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
|
Natural mouthwash for post oral cancer side effects |
|
Scientific Title of Study
|
Assessing the effectiveness of Propolis and Curcumin mouthwash in the management of Radiotherapy, Chemotherapy or combined modality induced Oral Mucositis - 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 |
Dr Ruhjaan Bhagat |
| Designation |
postgraduate resident |
| Affiliation |
SAVEETHA INSTITUTE OF MEDICAL AND TECHNICAL SCIENCES |
| Address |
Saveetha dental college and Hospitals, poonaamallee high road. Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
09004326428 |
| Fax |
|
| Email |
ruhjaan95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruhjaan Bhagat |
| Designation |
postgraduate resident |
| Affiliation |
SAVEETHA INSTITUTE OF MEDICAL AND TECHNICAL SCIENCES |
| Address |
Saveetha dental college and Hospitals, poonaamallee high road. Chennai
TAMIL NADU
600077
India |
| Phone |
09004326428 |
| Fax |
|
| Email |
ruhjaan95@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ruhjaan Bhagat |
| Designation |
postgraduate resident |
| Affiliation |
SAVEETHA INSTITUTE OF MEDICAL AND TECHNICAL SCIENCES |
| Address |
Saveetha dental college and Hospitals, poonaamallee high road. Chennai
TAMIL NADU
600077
India |
| Phone |
09004326428 |
| Fax |
|
| Email |
ruhjaan95@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Ruhjaan Bhagat |
| Address |
Clinic 20, department of oral medicine and radiology. Saveetha dental college and Hospitals, poonaamallee high road. Chennai
Saveetha dental college and Hospitals, poonaamallee high road. Chennai |
| Type of Sponsor |
Other [self-funded] |
|
|
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 Ruhjaan Bhagat |
Saveetha Dental College and Hospitals |
Clinic 20, department of oral medicine and radiology. Saveetha dental college and Hospitals, poonaamallee high road. Chennai
Saveetha dental college and Hospitals, poonaamallee high road. Chennai
Chennai
TAMIL NADU |
9004326428
ruhjaan95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SAVEETHA DENTAL COLLEGE-INSTITUTIONAL HUMAN ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K123||Oral mucositis (ulcerative), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Magic mouthwash |
Combination of 3 parts:
1) Diphenhydramine
2) Geulusil MPS antacid
3) Lignox 2%
Frequency will be 3 times daily until the radiotherapy/chemotherapy/both is going on with review once in 15 days. |
| Intervention |
Propolis and Curcumin mouthwash |
A mouthwash made with combining propolis derived from honeycomb and curcumin derived from turmeric for oral cancer patients undergoing radiation and/or chemotherapy post-surgery. Frequency will be 3 times daily until the radiotherapy/chemotherapy/both is going on with review once in 15 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1) Age 18 - 80 years of age.
2) Histopathologically confirmed oral squamous cell carcinoma cases who underwent surgery for oral cancer.
3) Patients undergoing conventional or intensity-modulated radiation therapy with cumulative dose of more than or equal to 50 Gy to oral cavity/oropharynx region.
4) No pre existent oral mucositis |
|
| ExclusionCriteria |
| Details |
1) Age less than 18 years of age
2) Previous history of Radiotherapy or chemotherapy to the head and neck region.
3) Allergic to propolis, beeswax or any other component of mouthwash.
4) Systemic severe diseases |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Reduction in WHO grading of Oral Mucositis
2) Reduction in VAS score |
Until the radiotherapy/chemotherapy/both is going on with review once in 15 days upto 45 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) severity of oral mucositis
2) duration of oral mucositis |
Until the radiotherapy/chemotherapy/both is going on with review once in 15 days upto 45 days. |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 1 |
|
Date of First Enrollment (India)
|
01/05/2026 |
| 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="1"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [RUHJAAN95@GMAIL.COM].
- For how long will this data be available start date provided 09-01-2027 and end date provided 31-12-2027?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study evaluates the effectiveness of a novel combination mouthwash containing propolis and curcumin in managing oral mucositis among postoperative oral cancer patients undergoing radiotherapy and/or chemotherapy. Oral mucositis severity will be assessed using WHO grading criteria at regular intervals to compare outcomes between those receiving the propolis-curcumin mouthwash and those on standard care. The research aims to determine whether this natural, cost-effective combination offers superior therapeutic benefits compared to conventional management, potentially providing a safer alternative for this distressed patient population. |