| CTRI Number |
CTRI/2025/10/096186 [Registered on: 17/10/2025] Trial Registered Prospectively |
| Last Modified On: |
07/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Non Drug, Herbal Based Intervention] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of coconut oil aloe vera mouth rinse on radiation-induced xerostomia among head and neck cancer patients. |
|
Scientific Title of Study
|
Effectiveness of coconut oil aloe vera mouth rinse on radiation-induced xerostomia among head and neck cancer patients. |
| 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 Chinthaja J |
| Designation |
PG Student |
| Affiliation |
Nitte Usha Institute of Nursing Sciences |
| Address |
Nitte Usha Institute of Nursing Sciences,Paneer, Kotekar Beeri Road, Deralakatte, Mangaluru, Dakshina Kannada.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9148183938 |
| Fax |
|
| Email |
chinthaja.24ngms01@student.nitte.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr. HARISH DEYANNAVAR |
| Designation |
Associate Professor |
| Affiliation |
Nitte Usha Institute of Nursing Sciences |
| Address |
Nitte Usha Institute of Nursing Sciences,Paneer, Kotekar Beeri Road, Deralakatte, Mangaluru, Dakshina Kannada.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8050507699 |
| Fax |
|
| Email |
harish.deyannavar@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr. HARISH DEYANNAVAR |
| Designation |
Associate Professor |
| Affiliation |
Nitte Usha Institute of Nursing Sciences |
| Address |
Nitte Usha Institute of Nursing Sciences,Paneer, Kotekar Beeri Road, Deralakatte, Mangaluru, Dakshina Kannada.
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8050507699 |
| Fax |
|
| Email |
harish.deyannavar@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Nitte Usha Institute of Nursing Sciences, Paneer, Kotekar Beeri Road, Deralakatte, Mangaluru, Dakshina Kannada, Karnataka, India - 575018 |
|
|
Primary Sponsor
|
| Name |
Ms Chinthaja J |
| Address |
Nitte Usha Institute of Nursing Sciences, Paneer, Kotekar Beeri Road, Deralakatte, Mangaluru, Dakshina Kannada, Karnataka, India - 575018 |
| Type of Sponsor |
Other [Self funded] |
|
|
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 HARISH DEYANNAVAR |
Justice K.S. Hegde Charitable Hospital |
Oncology Block, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA |
8050507699
harish.deyannavar@nitte.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, NUINS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C14||Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Coconut oil Aloevera Mouth rinse |
This study involves an intervention where participants in the experimental group are administered with coconut oil aloe vera mouth rinse (1:1 ratio) for 30-40 seconds, thrice a day, for 7 days. The severity of xerostomia is assessed at baseline (day 0) and reassessed on alternate days using the Challacombe Oral Dryness Scale and GRIX Questionnaire. |
| Comparator Agent |
Standard Care |
The participants in the control group receive standard care. The severity of xerostomia is assessed at baseline (day 0) and reassessed on alternate days using the Challacombe Oral Dryness Scale and GRIX Questionnaire. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Cancer patients who:
1. Have received external radiation therapy targeting the head and neck areas, with a minimum of four sessions.
2. Experience mild xerostomia (scores one to three) to moderate xerostomia (scores four to six) after radiation therapy.
|
|
| ExclusionCriteria |
| Details |
Cancer patients who:
1. Have a history of xerostomia before receiving radiation therapy.
2. Are allergic to coconut oil or aloe vera.
3. Experience difficulty in performing mouth rinsing.
4. Have undergone oral surgery recently.
5. Have any systemic diseases that reduce or suppress salivation.
6. Are using medications known to suppress salivation. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in severity of xerostomia measured using Challacombe Oral Dryness Scale and subjective symptoms using Groningen Radiation-Induced Xerostomia (GRIX) Questionnaire. |
Baseline (Day 0), alternate days up to Day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Safety of using coconut oil aloe vera mouth rinse
Association between the severity of xerostomia with selected clinical variables |
Day 0 and Day 7 |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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)
|
20/10/2025 |
| 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="0"
Months="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study aims to evaluate the efficacy of coconut oil aloe vera mouthrinse on radiation-induced xerostomia among patients with head and neck cancer. A total of 82 patients will be recruited using purposive sampling and allocated into experimental and control groups. The experimental group will receive coconut oil aloe vera mouth rinse thrice daily for 7 days, while the control group will receive standard care. The severity of xerostomia will be assessed using the Challacombe Oral Dryness Scale and subjective symptoms using the GRIX Questionnaire. This
study is significant as it will give evidence of the effectiveness of a
natural, non-invasive treatment for radiation-induced xerostomia. The findings
will help researchers better understand whether this strategy can help treat
dry mouth symptoms in head and neck cancer patients without the use of
medicines. Depending on the findings, the study may influence therapeutic
practices and inform judgements on cost-effective xerostomia care options, with
the ultimate goal of improving patient comfort before and after radiation
therapy |