| CTRI Number |
CTRI/2018/05/013936 [Registered on: 17/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
17/05/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Turmeric Oral Rinse in Oral Mucositis |
|
Scientific Title of Study
|
An Open Label, 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/2016/10; Version 01; Date:22.01.2016 |
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 Radiation Oncology, 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 Radiation Oncology,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, Makali, Bangalore
Makali, Bangalore
Bangalore
KARNATAKA
562123
India |
| Phone |
09901845412 |
| Fax |
|
| Email |
dr.padmanabha@himalayawellness.com |
|
|
Source of Monetary or Material Support
|
| Hospital and Institutional facilities Aspects: M.S. Ramaiah Medical College and Hospitals Ethics Committee |
|
|
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 |
Room No: 02; M.S.
Ramaish Advanced
Learning Centre,
Post,New BEL Road,
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 |
NIL |
NIL |
| Intervention |
Turmeric Oral Rinse |
subjects will be advised to use 10 ml of oral rinse for 1 minute 4 times daily for a period of 6 weeks starting from day 1 of standard anticancer care. |
|
|
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
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Mucositis Assessment:
Condition of the patient’s mouth is assessed at weekly intervals, as per the World Health Organisation grading of mucositis |
At entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5th week and end of 6th week |
|
|
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 5th week and end of 6th week |
| Location of ulcers |
At entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5th week and end of 6th week |
| Burning sensation |
At entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5th week and end of 6th week |
| Difficulty in chewing |
At entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5th week and end of 6th week |
| Difficulty in drinking |
At entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5th week and end of 6th week |
| 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 5th week and end of 6th week |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
08/06/2016 |
| Date of Study Completion (India) |
13/12/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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 Clinical Study to Evaluate the Efficacy and Safety of Turmeric Oral Rinse in Oral Mucositis during Cancer Chemotherapy and Radiotherapy. Forty subjects who fulfil the inclusion criteria will be selected. The subjects will be advised to use 10 ml of oral rinse to rinse/swish the mouth for 1 minute four times a day from day 1 of standard care. The subjects will be instructed to attend for follow up at the end of every week for 6 weeks. The primary outcome measures are Clinical assessments of Mucositis as per the World Health Organisation grading. Outcome measures will be measured at entry, end of 1st week, end of 2nd week, end of 3rd week, end of 4th week, end of 5th week and end of 6th week. Clinical symptoms like sore throat, number of ulcer, burning sensation, pain, difficulty in chewing, difficulty in drinking and mucositis grading along with PROMS (patient reported outcome measures) were evaluated at each interval. Significant positive outcome was reported both subjectively and objectively with delay in the onset of symptoms and less severe manifestation of oral mucositis with an improvement in quality of life. No adverse effects reported that prompted discontinuation of study medication. Overall compliance to study medication was good. |