| CTRI Number |
CTRI/2017/06/008833 [Registered on: 14/06/2017] Trial Registered Retrospectively |
| Last Modified On: |
12/06/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to check the effectiveness of turmeric mouthwash in preventing oral ulcers in patients receiving radiation therapy |
|
Scientific Title of Study
|
A randomized controlled trial to assess the effectiveness of turmeric solution mouthwash in preventing oral mucositis in patients attending radiotherapy OPD, PGIMER, Chandigarh (2016- 2017) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bankerlin B Lynser |
| Designation |
Student |
| Affiliation |
National Institute of Nursing Education |
| Address |
National Institute of Nursing Education, Post Graduate Institute of Medical Education and Research,Chandigarh
160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9774258079 |
| Fax |
|
| Email |
bankerlynser96@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neena Vir Singh |
| Designation |
Lecturer |
| Affiliation |
National Institute of Nursing Education |
| Address |
National Institute of Nursing Education, Post Graduate Institute of Medical Education and Research, Chandigarh
160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8146552482 |
| Fax |
|
| Email |
neenasingh_2@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Bankerlin B Lynser |
| Designation |
Student |
| Affiliation |
National Institute of Nursing Education |
| Address |
National Institute of Nursing Education, Post Graduate Institute Of medical Education and Research, Chandigarh
160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9774258079 |
| Fax |
|
| Email |
bankerlynser96@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Bankerlin B Lynser |
| Address |
National Institute of Nursing Education, PGIMER, Chandigarh |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Bikash Medhi |
Professor, Department of Pharmacology, PGIMER, Chandigarh |
| Dr Sukhpal Kaur |
Lecturer, National Institute of Nursing Education, PGIMER, Chandigarh |
| Dr Sushmita Ghoshal |
Head of Department, Department of Radiology, PGIMER, Chandigarh |
| Ms Neena Vir Singh |
Lecturer, National Institute of Nursing Education, PGIMER, Chandigarh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Bankerlin B Lynser |
Nehru Hospital, Post Graduate Institute of Medical Education and Research, Chandigarh |
Department of Radiotherapy, Radiotherapy OPD, Ground floor, Cobalt Block,Room No. 5
Chandigarh
CHANDIGARH |
9774258079
bankerlynser96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, PGIMER, Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Head and Neck Cancer patients receiving radiotherapy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Routine care |
Disprin gargle |
| Intervention |
Turmeric Mouthwash |
1.5 gms of turmeric powder mixed in 50 ml of water |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients suffering from head and neck cancer undergoing radiotherapy for the first time with normal mucosa |
|
| ExclusionCriteria |
| Details |
Patients planned for palliative radiotherapy and patients <18 years |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| prevention of development of oral mucositis |
18-07-2016 to 31-10-2016 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
18/07/2016 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="13" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The purpose of the study is to prevent the development of oral mucositis in cancer patients receiving radiotherapy. The hypothesis of the study is that turmeric mouthwash can prevent the development of oral mucositis in cancer patients receiving radiotherapy. |