| CTRI Number |
CTRI/2025/07/091959 [Registered on: 29/07/2025] Trial Registered Prospectively |
| Last Modified On: |
28/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Studying how well honey works when applied to the mouth to treat mouth sores caused by radiation in patients with head and neck cancer admitted in AVBRH Hospital |
|
Scientific Title of Study
|
Assess the effectiveness of topical application of honey in the management of radiation induced oral mucositis among the head and neck cancers patient admitted in AVBRH hospital |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tarun Ajit |
| Designation |
PG Student |
| Affiliation |
Datta Meghe Institute Of Higher Education And Research |
| Address |
Department of Medical Surgical Nursing Oncology Smt Radhikabai Meghe Memorial College Of Nursing Sawangi Meghe Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
8180073387 |
| Fax |
|
| Email |
ajittarun1791@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ruchira Ankar |
| Designation |
HOD Of Medical Surgical Nursing |
| Affiliation |
Datta Meghe Institute Of Higher Education And Research |
| Address |
Smt Radhikabai Meghe Memorial College Of Nursing Sawangi Meghe Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
7620978673 |
| Fax |
|
| Email |
ruchira3110@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ruchira Ankar |
| Designation |
HOD Of Medical Surgical Nursing |
| Affiliation |
Datta Meghe Institute Of Higher Education And Research |
| Address |
Smt Radhikabai Meghe Memorial College Of Nursing Sawangi Meghe Wardha
MAHARASHTRA
442001
India |
| Phone |
7620978673 |
| Fax |
|
| Email |
ruchira3110@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute Of Higher Education And Research Smt Radhikabai Meghe Memorial College Of Nursing Sawangi Meghe Wardha India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute Of Higher Education And Research |
| Address |
Smt Radhikabai Meghe Memorial College Of Nursing Sawangi Meghe Wardha India 442001 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Ruchira Ankar |
Datta Meghe Institute Of Higher Education And Research |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Tarun Ajit |
Acharya Vinoba Bhave Rural Hospital Wardha Siddharth Gupta Memorial Cancer hospital |
Department Of Radiation Basement And Oncology Ward 1st floor AVBRH Sidhharth Gupta Memorial Cancer Hospital Sawnagi Meghe Wardha India 442001
Wardha
MAHARASHTRA |
8180073387
ajittarun1971@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C040||Malignant neoplasm of anterior floor of mouth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Honey |
It is topical application applied at the patients oral cavity at mucositis to reduce the inflammtaion of the mucositis |
| Intervention |
Topical Application |
Honey is being used in topical application to reduce mucositis |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Adults aged 18 to 60 yr.
2.Diagnosed with head and neck cancers undergoing radiotherapy.
3.Development of radiation-induced oral mucositis (grade 2 or higher).
|
|
| ExclusionCriteria |
| Details |
1.History of allergic reactions to honey.
2.Patients with pre-existing severe oral conditions (e.g., advanced periodontal disease or active infections).
3.Individuals with compromised immune systems (e.g., uncontrolled diabetes or active chemotherapy).
|
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effectiveness of topical honey application in reducing the incidence and severity of radiation-induced oral mucositis in patients undergoing head and neck cancer treatment. |
3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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 2 |
|
Date of First Enrollment (India)
|
10/10/2025 |
| 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="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 - NO
|
|
Brief Summary
|
As we know that, The cancer is the harmful diseases for anyone. Here i am doing study on checking comparison between radiation therapy or topical honey therapy. Which is most effective for cancer ill Patients because radiation harm the patient as well as healthcare worker. so here i am to check the result of topical honey therapy for oral mucositis patients. |