| CTRI Number |
CTRI/2023/05/052548 [Registered on: 11/05/2023] Trial Registered Prospectively |
| Last Modified On: |
12/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of medicated oil pulling therapy in post radiation of oral cancer Patients |
|
Scientific Title of Study
|
Assessment of comparative efficacy of medicated oil pulling therapy versus Benzydamine mouthwash in post radiation mucositis of oral cancer Patients- A Pilot Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sheetal Asutkar |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research Centre |
| Address |
Room no.13 Department of Shalya Tantra Mahathma Gandhi Ayurveda College and Institute Salod (H) Wardha Maharashtra
Wardha
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9766811974 |
| Fax |
|
| Email |
sheetalasutkar16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pramod Borghare |
| Designation |
Associate Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research Centre |
| Address |
Room no.14 Department of Shalakya Tantra Mahathma Gandhi Ayurveda College and Institute Salod (H) Wardha Maharashtra
Wardha
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9881225532 |
| Fax |
|
| Email |
drpramodborghare@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sheetal Asutkar |
| Designation |
Professor and HOD |
| Affiliation |
Datta Meghe Institute of Higher Education and Research Centre |
| Address |
Room no.13 Department of Shalya Tantra Mahathma Gandhi Ayurveda College and Institute Salod (H) Wardha Maharashtra
Wardha
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9766811974 |
| Fax |
|
| Email |
sheetalasutkar16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Ayurveda College and Hospital |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Ayurveda College and Hospital |
| Address |
Mahatma Gandhi Ayurveda College and Hospital Salod Wardha 442001 Maharashtra |
| 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 Sheetal Asutkar |
MAHATMA GANDHI AYURVEDA COLLEGE HOSPITAL AND RESEARCH IINSTITUE |
Room No 13 Dept of Shalya Tantra Mahatma Gandhi Ayurved
College Datta Meghe Institute of Higher Education and Research
Wardha
MAHARASHTRA
442001
India
Wardha
MAHARASHTRA |
9766811974
sheetalasutkar16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K123||Oral mucositis (ulcerative). Ayurveda Condition: MUKHAROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Benzydamine mouthwash | Benzydamine mouthwash 5 to 10 ml will be given twice daily for 5 to 7 mins each for 15 days after radiation | | 2 | Intervention Arm | Procedure | - | kavalaH, कवलः | (Procedure Reference: , Procedure details: Oil pulling Therapy 5 to 10 ml will be given twice daily for 5 to 7 mins each for 15 days after radiation)
|
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Known cases of oral cancer patients who are having symptoms of radiation induced mucositis in the age group 18-60 years (post operated or pre operated cases) and who give written consent for the study will be included like
1. RIM with Mouth ulcers
2. RIM with Dysphagia
3. RIM with Pain in buccal cavity
4. RIM with Oral thrush
5. RIM with Candidiasis
6. RIM with Plaques
7. RIM with Gingivitis
8. RIM with Controlled diabetics will be included in the study
|
|
| ExclusionCriteria |
| Details |
Complicated cases of oral cancer with RIM will be excluded in the study like
1. Patients of Oral cancer with multiple sinuses
2. Uncontrolled Diabetic patients of Oral cancer with RIM will be excluded
3. Severe infection in the oral mucosa
4. Bleeding from lesion
5. Anemic patients below Hb- 9grams
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduced grade of- WHO oral mucositis Score |
4 week, 8 week, 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reductions in symptoms of dysphagia, bleeding, pain |
15th, 30th day |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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 3 |
|
Date of First Enrollment (India)
|
16/05/2023 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this study, Benzydamine mouthwash 5 to 10 ml will be given twice daily for 5 to 7 mins each for 15 days after radiation and another group by Oil pulling Therapy 5 to 10 ml will be given twice daily for 5 to 7 mins each for 15 days after radiation Patient will be assessed for WHO Oral mucositis score before and after oil pulling Therapy. Changes in the WHO Oral mucositis score will be noted. Follow-up will be taken every 15 days for 3 months. |