| CTRI Number |
CTRI/2018/06/014367 [Registered on: 01/06/2018] Trial Registered Prospectively |
| Last Modified On: |
28/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Turmeric mouth wash] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Use of Turmeric mouthwash on Oral health , radiation induced oral mucosal inflammation and associated oral dysfunctions among patients with Head and Neck Cancer. |
|
Scientific Title of Study
|
A randomized control study to evaluate the effectiveness of Turmeric mouthwash on Oral health status, Treatment induced oral mucositis and associated oral dysfunctions among patients with Head and Neck cancer. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prabha Lis Thomas |
| Designation |
Vice Principal |
| Affiliation |
Krupanidhi College Of Nursing |
| Address |
Krupanidhi College Of Nursing,Chikkabellandur,
Carmelaram P.O,Bangalore
Bangalore
KARNATAKA
560035
India |
| Phone |
9886451011 |
| Fax |
|
| Email |
prabha0575@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prabha Lis Thomas |
| Designation |
Vice Principal |
| Affiliation |
Krupanidhi College Of Nursing |
| Address |
Krupanidhi College Of Nursing,Chikkabellandur,
Carmelaram P.O,Bangalore
Bangalore
KARNATAKA
560035
India |
| Phone |
9886451011 |
| Fax |
|
| Email |
prabha0575@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prabha Lis Thomas |
| Designation |
Vice Principal |
| Affiliation |
Krupanidhi College Of Nursing |
| Address |
Krupanidhi College Of Nursing,Chikkabellandur,
Carmelaram P.O,Bangalore
Bangalore
KARNATAKA
560035
India |
| Phone |
9886451011 |
| Fax |
|
| Email |
prabha0575@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Shankara Cancer Hospital &Research Centre,1 st cross,Shankarapuram,Bengaluru-560004 |
|
|
Primary Sponsor
|
| Name |
Prabha Lis Thomas |
| Address |
Krupanidhi College Of Nursing,Chikkabellandur,Carmelaram P.O,Bangalore35 |
| Type of Sponsor |
Other [Prncipal investgator] |
|
|
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 |
| Prabha Lis Thomas |
Sri Shankara Cancer Hospital &Research Centre |
Radiation therapy department, triology room, 1 st cross,Shankarapuram,Basavanagudi,Bangalore,560004
Bangalore
KARNATAKA |
9886451011
prabha0575@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Shankara Cancer Hospital &Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C059||Malignant neoplasm of palate, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Benzydamine mouthwash |
Benzydamine mouthwash 10 ml ,6 times in a day from first day of radiation therapy to the end of radiation therapy |
| Intervention |
Turmeric mouth wash |
400 mg of standardized turmeric powder dissolved in 80 ml of boiled cooled water,administered 6 times in a day from first day of radiation therapy to the end of radiation therapy |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
diagnosed with head and neck cancer,receiving radiation therapy or concurrent chemotherapy at selected oncology hospitals
|
|
| ExclusionCriteria |
| Details |
not willing to participate in the study,with open mouth sores at study entry, using any other prophylactic mouthwashes,Terminally ill/palliative patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Onset and severity of Treatment induced oral mucositis, Oral dysfunctions and changes in oral health status |
Base line data at the starting of radiation therapy,weekly follow up at the end of fit weekcond wek,thid weekfourth week,fifth weeksixth and sevnth week. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Treatment break,No. of days missed,Weight loss |
End of radiation therapy |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="92" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/06/2018 |
| Date of Study Completion (India) |
31/12/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="6"
Days="5" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
2 publications |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
The proposed study is a randomized controlled trial to determine the effectiveness of turmeric mouthwash on oral health status,treatment induced oral mucositis and associated oral dysfunctions among Head and Neck Cancer patients receiving radiation therapy. |