| CTRI Number |
CTRI/2018/03/012371 [Registered on: 06/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
07/03/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical study on Turmeric mouth wash in the treatment of Oral ulcers due to cancer therapy. |
|
Scientific Title of Study
|
An Open Label, Comparative, Three-Arm, Randomized, Parallel Clinical Study to Evaluate the Efficacy and Safety of Turmeric Oral Rinse in Oral Mucositis during Cancer Chemotherapy and Radiotherapy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| HDC/CP/PP/015/2014 Version 1.0 dated 20-12-2014 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kirthi Koushik |
| Designation |
Radiation Oncologist |
| Affiliation |
M.S.Ramaiah Hospital |
| Address |
Department of Radiotherapy
M.S. Ramaiah Clinical Research Centre,
M.S. Ramaish Advanced Learning Centre,
Post, New BEL Road, Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
09901845412 |
| Fax |
|
| Email |
kirthi.koushik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kirthi Koushik |
| Designation |
Radiation Oncologist |
| Affiliation |
M.S.Ramaiah Hospital |
| Address |
Department of Radiotherapy
M.S. Ramaiah Clinical Research Centre,
M.S. Ramaish Advanced Learning Centre,
Post, New BEL Road, Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
09901845412 |
| Fax |
|
| Email |
kirthi.koushik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Padmanabha |
| Designation |
Research Associate |
| Affiliation |
The Himalaya Drug Company |
| Address |
Department of Clinical Pharmacology, The Himalaya Drug Company, Makali, Bangalore
Bangalore
KARNATAKA
562123
India |
| Phone |
|
| Fax |
|
| Email |
dr.padmanabha@himalayawellness.com |
|
|
Source of Monetary or Material Support
|
| The Himalaya Drug Company, Makali, Bangalore |
|
|
Primary Sponsor
|
| Name |
The Himalaya Drug Company |
| Address |
The Himalaya Drug Company
Research and Development,
Makali, Bangalore – 562 162
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 Kirthi Koushik |
M S Ramaiah Medical College and Hospital |
Department of Radiotherapy, M.S. Ramaiah Clinical
Research Centre, M.S. Ramaish Advanced Learning Centre, Post,New BEL Road, Bangalore
Bangalore
KARNATAKA |
09901845412
kirthi.koushik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| M.S. Ramaiah Medical College And Hospitals Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Subjects with head and neck cancer scheduled to receive chemotherapy or radiotherapy as standard care and with history or prone to develop oral mucositis during cancer chemotherapy or radiotherapy, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Normal saline |
To be used 10 ml of oral rinse to rinse/swish the mouth for 1 minute four times a day for 6 weeks. |
| Intervention |
Turmeric oral rinse variant 1 |
Turmeric oral rinse variant 1 (Turmeric oral rinse with xanthine gum)
To be used 10 ml of oral rinse to rinse/swish the mouth for 1 minute four times a day for 6 weeks. |
| Intervention |
Turmeric oral rinse Variant 2 |
Turmeric oral rinse variant 2 (Turmeric oral rinse without xanthine gum)
To be used 10 ml of oral rinse to rinse/swish the mouth for 1 minute four times a day for 6 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Subjects with confirmed histopathologically with head and neck cancer (according to TNM classification) preferably oropharyngeal scheduled to receive chemotherapy or radiotherapy as a standard care.
2 Subjects with history or prone to develop oral mucositis during cancer chemotherapy or radiotherapy.
3 Subjects aged >18 years of either the sex.
4 Subjects willing to give a written informed consent and follow the schedule of the study as per the protocol.
|
|
| ExclusionCriteria |
| Details |
1 Has participated in a similar clinical investigation in the past four weeks.
2 Severe uncontrolled systemic disorders, diabetes, Hypertension, or genetic and endocrinal disorders.
3 Has used a similar product in the past four weeks.
4 Subjects who refused to sign informed consent.
5 Pregnant and lactating women. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical assessment of Mucositis as per the World Health Organisation grading |
At entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5thweek and end of 6thweek |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of ulcers |
At entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5thweek and end of 6thweek |
| Location of ulcers |
At entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5thweek and end of 6thweek |
| Burning sensation |
At entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5thweek and end of 6thweek |
| Difficulty in chewing |
At entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5thweek and end of 6thweek |
| Difficulty in drinking |
At entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5thweek and end of 6thweek |
| Difficulty in opening the mouth |
At entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5thweek and end of 6thweek |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "45"
Final Enrollment numbers achieved (India)="45" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/07/2015 |
| Date of Study Completion (India) |
07/03/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="9"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is an open label comparative three-arm randomized parallel clinical study in which 2 variants of Turmeric Oral Rinse will be compared with normal saline for the efficacy and safety in patients during cancer chemotherapy and radiotherapy. Forty five ssubjects who fulfil the inclusion criteria will be selected. They will be randomised to one of the three groups namely Turmeric oral rinse variant 1 (Turmeric oral rinse with xanthine gum), Turmeric oral rinse Variant 2 (Turmeric oral rinse without xanthine gum) and Normal saline of 15 cases each. The subjects will be advised to use 10 ml of oral rinse to rinse/swish the mouth for 1 minute four times a day. The subjects will be instructed to attend for follow up at the end of every week for 6 weeks. The study was conducted at single centre in India. The primary outcome measures were Clinical assessments of Mucositis as per the World Health Organisation grading. Outcome measures were measured at entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5thweek and end of 6thweek. |