| CTRI Number |
CTRI/2024/10/074782 [Registered on: 04/10/2024] Trial Registered Prospectively |
| Last Modified On: |
20/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Methylene blue oral rinse in treating pain related to cancer treatment in mouth |
|
Scientific Title of Study
|
A Comparative study on assesing efficacy and safety of methylene blue oral rinse vs Standard therapy for treating pain from Oral Mucositis, related to cancer treatment in a tertiary care hospital-A Randomised Open labelled Prospective study. |
| 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 Viswanath S |
| Designation |
Postgraduate Pharmacology |
| Affiliation |
Tamilnadu Dr MGR Medical university |
| Address |
Department of Pharmacology,Second floor,Government Kilpauk medical college,Poonamalle high road,Kilpauk, Chennai
Tamilnadu Dr MGR Medical university, Anna Salai road, Guindy, Chennai-32
Chennai-32
Chennai
TAMIL NADU
600010
India |
| Phone |
9150301578 |
| Fax |
|
| Email |
sviswanath7298@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T Aruna |
| Designation |
Professor & Head of Department-Pharmacology |
| Affiliation |
Tamilnadu Dr MGR Medical university |
| Address |
Department of Pharmacology,Second floor,Government Kilpauk medical college,Poonamalle high road,Kilpauk, Chennai
Tamilnadu Dr MGR Medical university,Anna Salai road, Guindy, Chennai-32
Chennai-32
Chennai
TAMIL NADU
600010
India |
| Phone |
9444276923 |
| Fax |
|
| Email |
arunabala511@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T Aruna |
| Designation |
Professor & Head of Department-Pharmacology |
| Affiliation |
Tamilnadu Dr MGR Medical university |
| Address |
Department of Pharmacology,Second floor,Government Kilpauk medical college,Poonamalle high road,Kilpauk, Chennai
Tamilnadu Dr MGR Medical university,Anna Salai road, Guindy, Chennai-32
Chennai-32
TAMIL NADU
600010
India |
| Phone |
9444276923 |
| Fax |
|
| Email |
arunabala511@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Kilpauk Medical College,Poonamalle High Road,Kilpauk,Chennai-600010,Tamilnadu,India |
|
|
Primary Sponsor
|
| Name |
Government Kilpauk Medical College |
| Address |
Government Kilpauk Medical College,Poonamalle High Road,Kilpauk,Chennai-600010,Tamilnadu,India |
| Type of Sponsor |
Government medical college |
|
|
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 Viswanath S |
Government Royapettah hospital |
Room number 10,Department of Medical Oncology, Radiotherapy, Oncology block
Chennai
TAMIL NADU |
9150301578
sviswanath7298@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Kilpauk Medical College |
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 |
| Intervention |
Methylene Blue Oral rinse(0.1%) |
One mouthful (5–10 mL) of Methylene blue solution(0.1%) and hold it at the painful sites for 5 min. To be used every 6hours for 2days duration |
| Comparator Agent |
Salt Water Oral rinse |
One mouthful (5–10 mL) of Salt water solution and hold it at the painful sites for 5 min. To be used every 6hours for 2days duration.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
clinically diagnosed with Oral mucositis receiving chemotherapy/Radiotherapy for malignancy |
|
| ExclusionCriteria |
| Details |
Patients with known history of hypersensitivity to methylene blue, pregnancy, breastfeeding mothers, cognitive impairment, not able to give consent, known documented history of G6PD deficiency, asymptomatic cases, pain due to oral ulcers /growth which are diagnosed to be malignancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Numerical rating scale pain score will be assesed |
At baseline, day1 ,day 2 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Oral functioning burden(OFB) will be assesed |
at baseline, day 1,day2 |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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 4 |
|
Date of First Enrollment (India)
|
10/10/2024 |
| 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="0"
Months="3"
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 efficacy and safety of Methylene blue oral rinse (0.1%) in comparison with Standard therapy for treating pain from oral mucositis related to cancer treatment (Chemotherapy/Radiotherapy/both) in a tertiary care hospital. Participants satisfying the inclusion and exclusion criteria will be randomised into 2arms.Informed consent will be obtained. Study arm will receive methylene blue oral rinse(0.1%) every 6hours for 2days.Control arm will receive salt water rinse every 6hours for 2days.Numerical rating scale and Oral Functioning burden will be assesed at baseline,day1 and day2.participants will be monitored for any adverse events. |