| CTRI Number |
CTRI/2026/02/102711 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
31/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARATIVE ASSESSMENT OF MOUTHWASH CONTAINING POMEGRANATE AND GRAPEFRUIT SEED EXTRACT WITH POVIDONE IODINE IN
MANAGEMENT OF RADIATION INDUCED ORAL MUCOSITIS IN PATIENTS UNDERGOING RADIOTHERAPY. |
|
Scientific Title of Study
|
COMPARATIVE ASSESSMENT OF POMEGRANATE AND GRAPEFRUIT SEED EXTRACT WITH POVIDONE IODINE IN
MANAGEMENT OF RADIATION INDUCED ORAL MUCOSITIS. |
| 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 ZEENA GUPTA |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
GOVERNMENT DENTAL COLLEGE, RAIPUR |
| Address |
DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY
GOVERNMENT DENTAL COLLEGE,
RAIPUR (C.G.)
492001
Raipur
CHHATTISGARH
492001
India |
| Phone |
9584722199 |
| Fax |
|
| Email |
dr.zeena29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ZEENA GUPTA |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
GOVERNMENT DENTAL COLLEGE, RAIPUR |
| Address |
DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY
GOVERNMENT DENTAL COLLEGE,
RAIPUR (C.G.)
492001
Raipur
CHHATTISGARH
492001
India |
| Phone |
9584722199 |
| Fax |
|
| Email |
dr.zeena29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ZEENA GUPTA |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
GOVERNMENT DENTAL COLLEGE, RAIPUR |
| Address |
DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY
GOVERNMENT DENTAL COLLEGE,
RAIPUR (C.G.)
492001
Raipur
CHHATTISGARH
492001
India |
| Phone |
9584722199 |
| Fax |
|
| Email |
dr.zeena29@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr ZEENA GUPTA |
| Address |
DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY
GOVERNMENT DENTAL COLLEGE,
RAIPUR (C.G.)
492001 |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR SHILPA K JAIN |
DEPARTMENT OF ORAL MEDICINE AND RADIOLOGY
GOVERNMENT DENTAL COLLEGE,
RAIPUR (C.G.)
492001 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Zeena Gupta |
Dr. B. R. A. M. HOSPITAL, RAIPUR, CHHATTISGARH |
DEPARMENT OF RADIOTHERAPY,
ROOM NUMBER 43 AND 46
REGIONAL CANCER CENTER, RAIPURDr. B. R. A. M. HOSPITAL, RAIPUR, CHHATTISGARH
Raipur
CHHATTISGARH |
9584722199
dr.zeena29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE Pt. J. N. M. MEDICAL COLLEGE, RAIPUR (C.G.) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
POMEGRANATE AND GRAPEFRUIT SEED EXTRACT CONTAINING MOUTHWASH. |
PATIENTS WILL BE ADVISED TO RINSE WITH MOUTHWASH CONTAINING POMEGRANATE AND GRAPEFRUIT SEED EXTRACT FROM DAY ONE OF RADIOTHERAPY THRICE A DAY FOR SIX WEEKS. |
| Comparator Agent |
POVIDONE IODINE CONTAINING MOUTHWASH. |
PATIENTS WILL BE ADVISED TO RINSE WITH MOUTHWASH CONTAINING POVIDONE IODINE FROM DAY ONE OF RADIOTHERAPY THRICE A DAY FOR SIX WEEKS. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are willing to participate in the study and sign the written consent.
Patients who are diagnosed with histopathologically proven malignancy of oral cavity.
Patients who have been scheduled for postoperative external beam radiation therapy.
The patients who are receiving radiation therapy for the first time.
The patients who are scheduled to receive a total radiation dose ranging between 60 and 70 Gy.
The total duration of external beam radiation therapy should be not less than 6 weeks period delivered at 30 fractions.
Patients who are willing to come for weekly evaluation. |
|
| ExclusionCriteria |
| Details |
Patients not willing to participate in the study.
Patients with prior history of radiotherapy for any malignancy.
Patients who have received prior chemotherapy for the management of any past or present malignancy.
Patients diagnosed with Oral Submucous Fibrosis.
Patients having any systemic illnesses and taking medications for the same especially diabetes mellitus, hypertension, renal disorders, hepatic disorders, haematological disorders, immunological disorders, gastrointestinal disorders, etc.
Patients experiencing xerostomia and oral sores due to ill fitting dentures.
Patients taking analgesics for other medical conditions. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary outcome of the Study: -
The result of the study will help to determine whether extracts of pomegranate and grapefruit seed can be considered as effective
prophylactic and preventive measure for radiation induced oral mucositis. |
Six weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
It will also help reduce the medications which are currently being used for
palliative care among patients with radiation induced oral mucositis.
It will also reduce the hospitalization duration, and overall increase the
patient’s quality of life by preventing or reducing RIOM. |
Six weeks |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
12/02/2026 |
| 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="6"
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
|
The present study aims to compare and evaluate the efficacy of pomegranate and grapefruit seed extracts with povidone iodine mouthwash for prophylaxis and treatment of RIOM. Two groups of 30 patients each, who are scheduled to receive Radiotherapy involving oral cavity, shall be randomly assigned to either treatment or control groups. The study design involves administering the designated mouthwash to the respective groups and monitoring the patients health of oral mucosa over a specified period. Key parameters for evaluation include inflammation levels and severity of mucositis (if any) assessed by OMAS, symptoms of burning sensation with VAS and ease of swallowing, during radiation therapy. By comparing the outcomes between the two groups, the study aims to provide insights into the potential benefits of using pomegranate and grapefruit seed extracts as mouthwash for prophylaxis or treatment of RIOM. Such findings could contribute to enhancing RIOM treatment protocols and optimizing patient outcome during radiotherapy. |