| CTRI Number |
CTRI/2025/06/088696 [Registered on: 12/06/2025] Trial Registered Prospectively |
| Last Modified On: |
31/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive
Dentistry
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Low-level laser therapy versus herbal mouth wash in the management of radiation induced oral mucositis |
|
Scientific Title of Study
|
Comparative efficacy of low-level laser therapy versus herbal mouth wash in the management of radiation induced oral mucositis-A randomized controlled clinical single -blinded study”.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vaishnavi Kabra |
| Designation |
Post graduate student |
| Affiliation |
K M Shah Dental College and Hospital |
| Address |
Department of Oral Medicine and Radiology,Room no 1 K M Shah Dental College and Hospital
Sumandeep Vidyapeeth
Piparia, Vadodara.
Vadodara
GUJARAT
391760
India |
| Phone |
9145184941 |
| Fax |
|
| Email |
vaishukabra301@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR DEEPA JATTI PATIL |
| Designation |
Professor |
| Affiliation |
K M Shah Dental College and Hospital |
| Address |
Oral Medicine and Radiology,Room no 1 K M Shah Dental College and Hospital
Sumandeep Vidyapeeth
Piparia, Vadodara.
Oral Medicine and Radiology,Room no 1 K M Shah Dental College and Hospital
Sumandeep Vidyapeeth
Vadodara
GUJARAT
391760
India |
| Phone |
9145184941 |
| Fax |
|
| Email |
iafdeepa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vaishnavi Kabra |
| Designation |
Post graduate student |
| Affiliation |
K M Shah Dental College and Hospital |
| Address |
Oral Medicine and Radiology,Room no 1 K M Shah Dental College and Hospital
Sumandeep Vidyapeeth
Piparia, Vadodara.
Vadodara
GUJARAT
391760
India |
| Phone |
9145184941 |
| Fax |
|
| Email |
vaishukabra301@gmail.com |
|
|
Source of Monetary or Material Support
|
| KM SHAH DENTAL COLLEGE AND HOSPITAL,SUMANDEEP VIDYAPEETH,Waghodia,Vadodara |
|
|
Primary Sponsor
|
| Name |
Vaishnavi Kabra |
| Address |
Oral Medicine and Radiology,Room no 1 K M Shah Dental College and Hospital
Sumandeep Vidyapeeth |
| Type of Sponsor |
Private 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 |
| Vaishnavi Kabra |
]K M Shah Dental College and Hospital and SBKS Medical Institute and research centre |
Dept of Oral Medicine and Radiology, Room no 1 K M Shah Dental College and Hospital
Dept of Oncology,Room no 3SBKS MI & RC,SVDU
Sumandeep Vidyapeeth
Piparia, Vadodara.
Vadodara
GUJARAT |
09145184941
vaishukabra301@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethical Commitee |
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 |
| Comparator Agent |
Group 3 Participants will receive placebo[positive] with radiation induced oral mucositis. |
Participants receiving placebo[positive] composing of baking soda with turmeric with radiation induced oral mucositis. |
| Comparator Agent |
Group II-Poly herbal mouth wash will be prescribed twice daily for 5 weeks |
25 participants will be prescribed
a Poly herbal mouth wash twice daily for 5 weeks |
| Intervention |
Participants undergoing low level laser therapy with radiation induced oral mucositis |
25 participants will be submitted to low level laser therapy (Diode laser) twice a week, during the RT. The PBMT protocol will begin 1 week after the Radiotherapy session and will be conducted before RT session and continue until the end of the treatment. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Both male and female patients aged above 18 years will be included in the study.
Participants with histopathologically proven head and neck carcinoma scheduled to undergo radiotherapy involving at least two third of oral cavity in radiation field.
|
|
| ExclusionCriteria |
| Details |
1.Participants who do not wish to participate or refuse to give a written consent for the study will be excluded from the study.
2.Patients receiving induction chemotherapy or receiving concurrent chemotherapy for treatment of head and neck carcinoma
3. Patients undergoing palliative therapy, short duration radiotherapy will be excluded
4. Patients were excluded if they had lock jaw, any medical condition affecting healing mechanisms (like diabetes), prior radiation for head and neck carcinoma, were receiving any chemo-sensitizer and were not receiving high dose radiation to oral cavity region.
5.Patients allergic to the ingredients of mouthwash.
6.Elderly patients with morbidity, pregnant and lactating females
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
• To assess and compare the intensity and duration of radiation-induced oral mucositis between low level laser therapy, polyherbal mouth wash and placebo group by World Health organization (WHO) scale and Oral Mucositis Assessment Scale (OMAS).
• To assess and compare the maximum pain score by visual analog scale of radiation-induced oral mucositis between low level laser therapy, polyherbal mouth wash and placebo group.
|
• Baseline, 3rd week and 6th week.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To evaluate quality of life by European organisation for research and treatment of cancer (EORTC QLQ) questionnaire in participants before and after treatment of radiation-induced oral mucositis between low level laser therapy, polyherbal mouth wash and placebo group
• To assess the incidence of supplemental nutrition through feeding tube between low level laser therapy, polyherbal mouth wash and placebo group
• To assess body weight loss between low level laser therapy, polyherbal mouth wash and placebo group
• To assess incidence and duration of radiation therapy interruption if any between low level laser therapy, polyherbal mouth wash and placebo group.
|
2nd week to sixth week |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2025 |
| 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="1"
Months="6"
Days="10" |
|
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
|
Oral mucositis (OM) refers to erythematous and painful ulcerative lesions of the oral mucosa observed in patients with cancer, who are treated with chemotherapy, and/or with radiation therapy. According to the majority of studies, this complication occurs in up to 80% of patients receiving high-dose chemotherapy, and in up to 100% of patients receiving radiotherapy for head and neck cancer, and approximately 20–40% in those, who receive conventional chemotherapy. For prevention and management of OM, it is crucial to employ an efficient compound with likely safety profile which is easy to use. Currently, commercially therapeutic mouthwashes in the market have high alcohol content, causing a burning sensation in the oral cavity. They may also cause toxicity if swallowed or consumed in excess. Herbal mouthwashes can reduce the intensity and duration of OM as well as reduce the pain scores with lesser side effects. The formulation used in the present study (Liquorice, pomegranate extract, clove oil, aloe vera and honey) has not been utilsed before and can be a novel approach for treatment of oral mucositis. Several treatment methods have been used to prevent and treat cancer therapy induced OM, but none has proven complete success against OM until date and have been performed on limited sample size. In this clinical study, we aim to evaluate the effect of the polyherbal mouthwashes in comparison to LLLT and placebo groups for prevention of radiation-induced OM. In this clinical study, we aim to evaluate the effect of the polyherbal mouthwashes in comparison to LLLT and placebo groups for prevention of radiation-induced OM. |