| CTRI Number |
CTRI/2025/07/092109 [Registered on: 31/07/2025] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Use Of Cucumber Peppermint Oil Ice Cube For Oral Mucositis |
|
Scientific Title of Study
|
An Experimental Study To Assess The Effectiveness Of Cucumber Peppermint Oil Ice Cube On Oral Mucositis Among Patients Receiving Chemotherapy. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ms Rashmi Chavan |
| Designation |
Assistant Professor |
| Affiliation |
K.J.Somaiya college of nursing |
| Address |
K J Somaiya College of Nursing
4th floor college building
Ayurvihar complex
Eastern Express Highway
Sion East
department nursing
-
Mumbai (Suburban)
MAHARASHTRA
400067
India |
| Phone |
09930390447 |
| Fax |
- |
| Email |
rashmi.chavan@somaiya.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Shubhangi Pangam |
| Designation |
Vice-Principal |
| Affiliation |
P D Hinduja College of Nursing |
| Address |
DWingEmeraldCourt KondivitaLaneMarolPipeLine
Andheri East
Mumbai (Suburban)
MAHARASHTRA
400059
India |
| Phone |
|
| Fax |
- |
| Email |
shubhs29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Rashmi Chavan |
| Designation |
Assistant Professor |
| Affiliation |
K.J.Somaiya college of nursing |
| Address |
K J Somaiya College of Nursing
4th floor college building
Ayurvihar complex Eastern Express Highway
Sion East
department nursing
-
Mumbai (Suburban)
MAHARASHTRA
400067
India |
| Phone |
09930390447 |
| Fax |
- |
| Email |
rashmi.chavan@somaiya.edu |
|
|
Source of Monetary or Material Support
|
| P D Hinduja hospital and research centre |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Ms Rashmi Chavan |
P D Hinduja Hospital & Medical Research centre |
Oncology department, medical oncology, room no.1
Mumbai
MAHARASHTRA |
09930390447
rashmi.chavan@somaiya.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sadhu Vaswani College of Nursing, Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C060||Malignant neoplasm of cheek mucosa, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cucumber Peppermint oil ice cube |
Cucumber Peppermint oil ice cube is given to patients receiving chemotherapy.
|
| Comparator Agent |
standard intervention according to the hospital policy |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients receiving chemotherapy in any cycle of the treatment
2. Patients receiving chemotherapy drugs such as 5 Fluorouracil, Cisplatin, Doxorubicin, Methotrexate.
3.Patients who are willing to participate in the study.
4.Patients who can follow instructions
5.Patients who can swallow
|
|
| ExclusionCriteria |
| Details |
1.Patients who are critically ill
2.Patients receiving Oxaliplatin
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oral mucositis |
before and after the intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1.change in the patients ability to swallow |
NIL |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/09/2025 |
| 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="1"
Days="1" |
|
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 study will be published after the Analysis of the data. |