| CTRI Number |
CTRI/2018/04/013285 [Registered on: 16/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
04/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Efficacy of antioxidants in the management of Oral submucous fibrosis |
|
Scientific Title of Study
|
Efficacy of Lycopene versus Lycopene and Curcumin in the management of Oral submucous fibrosis a randomized clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suneel kumar |
| Designation |
Reader Department of Oral Medicine and Radiology |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Narayana Dental College and Hospital
Department Oral Medicine and Radiology
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9347100413 |
| Fax |
08612305092 |
| Email |
dr21suneel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sudeepthi Pulimi |
| Designation |
Postgraduate Student |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Department Oral Medicine and Radiology
Narayana Dental College
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
8500758749 |
| Fax |
08612305092 |
| Email |
dr.pulim@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kannan |
| Designation |
Professor and Head Oral Medicine and Radiology |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Department of Oral Medicine and Radiology
Narayana Dental College and Hospital
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9490471078 |
| Fax |
08612305092 |
| Email |
dentkan1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Narayana dental college
Chinthareddypalem
Nellore |
|
|
Primary Sponsor
|
| Name |
Narayana Dental College and Hospital |
| Address |
Narayana Dental College and Hospital
Chinthareddypalem
Nellore |
| 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 |
| Kannan Natarajan |
Narayana Dental College and Hospital |
Department of Oral Medicine and Radiology
Nellore
ANDHRA PRADESH |
9490471078
08612305092
dentkan1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of Narayana Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
50 Oral Submucous Fibrosis Patients, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Combined therapy with lycopene and curcumin |
2000mcg lycopene twice daily and circuit h 400mg once daily orally for period of three months |
| Intervention |
lycopene capsules |
2000mcg orally twice daily orally for three months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
25 Oral Submucous Fibrosis patients to be put on Systemic lycopene therapy alone
25 Oral Submucous Fibrosis patients to be put on a combination of Lycopene and Curcumin |
|
| ExclusionCriteria |
| Details |
Hypersensitivity to Curcumin and /or lycopene
Patients with Gall Stones and other Gastrointestinal disorders Patients with Fibrotic lesions other than Oral Sub Mucous Fibrosis Patients receiving any other medications |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Relief from Burning Sensation
Improved Interincisal Mouth Opening
Cheek Mucosa Flexibility Improvement |
at end of first month and at the end of three months after starting the therapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Relief from Burning Sensation
|
3 Months |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2017 |
| Date of Study Completion (India) |
01/03/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Background and objectives The review of current literature showed that combined use of antioxidants in the treatment of oral submucous fibrosis was not adequately explored and research in this area is very limited. Hence the present randomized clinical trail was carried out to evaluate the efficacy of Lycopene versus Lycopene and circumin in the management of Oral submucous fibrosis. Trail was completed Randomized Clinical Trial of lycopene versus Curcumin with lycopene in management of Oral Submucous Fibrosis with end points being improvement in Interincisal Mouth opening, Cheek Flexibility and Reduction in Burning Sensation among patients with combined therapy by the time trial was Completed.
|