| CTRI Number |
CTRI/2024/05/067571 [Registered on: 17/05/2024] Trial Registered Prospectively |
| Last Modified On: |
09/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Green Tea(Camellia sinensis) Based Mouthwash] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effectiveness of green tea based mouth rinse on oral health status, pain and Quality of life |
|
Scientific Title of Study
|
A study to assess the effectiveness of green tea (Camellia sinensis) based mouth rinse on oral health status, pain and quality of life among advanced head and neck cancer patients in a tertiary care centre. — Randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Meghmaa Roy |
| Designation |
Msc. Nursing Student (Oncology) |
| Affiliation |
AIIMS, NEW DELHI |
| Address |
Porta Cabin 1
College of Nursing
AIIMS NEW DELHI
Ansari Nagar
South West
DELHI
110029
India |
| Phone |
8927588861 |
| Fax |
|
| Email |
meghmaa.17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Meghmaa Roy |
| Designation |
Msc. Nursing Student |
| Affiliation |
AIIMS, NEW DELHI |
| Address |
Porta Cabin 1
College of Nursing
AIIMS NEW DELHI
Ansari Nagar
South West
DELHI
110029
India |
| Phone |
8927588861 |
| Fax |
|
| Email |
meghmaa.17@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Ujjwal Dahiya |
| Designation |
Associate Professor |
| Affiliation |
AIIMS NEW DELHI |
| Address |
Room No 3
College of Nursing
AIIMS NEW DELHI
Ansari Nagar
South West
DELHI
110029
India |
| Phone |
9899770134 |
| Fax |
|
| Email |
ujjwaldahiya3@gmail.com |
|
|
Source of Monetary or Material Support
|
| BRA IRCH, AIIMS NEW DELHI
Ansari Nagar, Pin 110029 |
|
|
Primary Sponsor
|
| Name |
AIIMS NEW DELHI |
| Address |
College of Nursing
AIIMS NEW DELHI
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 Rakesh Garg |
BRA IRCH AIIMS NEW DELHI |
Palliative Care unit, ground floor, Room No 60, IRCH, AIIMS NEW DELHI
South West
DELHI |
9810394950
drrgarg@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee For Post Graduate Research , AIIMS New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-C14||Malignant neoplasms of lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Green Tea (Camellia sinensis) based mouth rinse |
Green tea bags will be provided to patients to make mouth rinse at home. They will rinse their mouth 3 times per day after 3 major meal for 6 weeks. Needed Tea bags will be provided at 2 weeks interval when they will come for follow up. The tag containing the brand name of the tea bag will be covered by the researcher.In this way patients will be blinded to the brand name of green tea bag. |
| Comparator Agent |
Standard care |
Standard care includes maintaining a good oral hygiene. An informational video regarding routine oral care will be provided to patients. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Advanced head and neck cancer patients aged more than 18 years old
Receiving palliative chemotherapy or radiotherapy |
|
| ExclusionCriteria |
| Details |
Patients suffering from any mental illness
Not willing to participate in the study |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Oral Health Status of advanced head and neck cancer patients |
At time of enrollment then every 2 weekly upto 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pain
Quality Of Life |
At time of enrollment then every 2 weekly upto 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
01/08/2024 |
| 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="6"
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
|
The study titled " A study to assess the effectiveness of Green Tea (Camellia sinensis) based mouth rinse on oral health status, pain and quality of life among advanced head and neck cancer patients in a tertiary care centre- Randomized controlled trial" is an experimental study. It will be conducted to know if green tea has any role or not on improving oral health status, oral health related quality of life and decreasing pain among advanced head and neck cancer patients. |