CTRI Number |
CTRI/2022/12/047901 [Registered on: 06/12/2022] Trial Registered Prospectively |
Last Modified On: |
05/12/2022 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug Dentistry |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
A HOSPITAL BASED STUDY TO COMPARE THE EFFICACY OF LYCOPENE AND SERRATIOPEPTIDASE IN THE MANAGEMENT OF ORAL SUBMUCOUS FIBROSIS |
Scientific Title of Study
|
A Hospital-Based Experimental Prospective Study To Compare The Efficacy Of Lycopene And Serratiopeptidase In The Management of Oral Submucous Fibrosis |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Humaira Hussain |
Designation |
Post Graduate Student |
Affiliation |
RISHIRAJ COLLEGE OF DENTAL SCIENCES AND RESEARCH CENTRE |
Address |
B 171 Indra Vihar Colony Airport Road Room No. 101
Department Of Oral Medicine And Radiology
Rishiraj College Of Dental Sciences And Research Centre
Gandhinagar Airport Road Bhopal MADHYA PRADESH 462030 India |
Phone |
9630563750 |
Fax |
07552528524 |
Email |
faridahussain33@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Kriti Shrivastava |
Designation |
Reader |
Affiliation |
Rishiraj College Of Dental Sciences And Research Centre |
Address |
Flat 201, A8 Banyan Heights
Blue Sky High Rise
Aakriti Ecocity
Bhopal Room No. 101
Department Of Oral Medicine And Radiology
Rishiraj College Of Dental Sciences And Research Centre Bhopal MADHYA PRADESH 462026 India |
Phone |
9425693111 |
Fax |
07552528524 |
Email |
drkshrivastava11@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Kriti Shrivastava |
Designation |
Reader |
Affiliation |
Rishiraj College Of Dental Sciences And Research Centre |
Address |
Flat 201, A8 Banyan Heights
Blue Sky High Rise
Aakriti Ecocity
Bhopal Room No 101
Department Of Oral Medicine And Radiology
Rishiraj College Of Dental Sciences And Research Centre
Gandhinagar Airport Road Bhopal MADHYA PRADESH 462026 India |
Phone |
9630563750 |
Fax |
07552528524 |
Email |
drkshrivastava11@gmail.com |
|
Source of Monetary or Material Support
|
Rishiraj College Of Dental Sciences And Research Centre
Gandhinagar Airport Road
Bhopal MP |
|
Primary Sponsor
|
Name |
HUMAIRA HUSSAIN |
Address |
B-171 INDRA VIHAR COLONY AIRPORT ROAD BHOPAL MP |
Type of Sponsor |
Other [SELF FUNDED] |
|
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 |
HUMAIRA HUSSAIN |
RISHIRAJ DENTAL COLLEGE |
Room No. 101 Department Of Oral Medicine And Radiology Gandhinagar Airport Road Bhopal MADHYA PRADESH |
9630563750 07552528524 faridahussain33@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
RCDS ETHICAL COMMITTEE |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: K135||Oral submucous fibrosis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
LYCOPENE |
ANTIOXIDANT
Dose - 8 mg twice daily for 4 weeks
Route - Oral
|
Intervention |
SERRATIOPEPTIDASE |
FIBRINOLYTIC (PROTEOLYTIC ENZYME)
Dose - 10 mg thrice daily for 4 weeks
Route- Oral |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
For establishment of oral submucous fibrosis diagnosis, two parame-ters mentioned below were to be satisfied for inclusion in the pre-sent study-
(a) Positive history of chewing areca nut or one of its commercial preparations, difficulty in swallowing and chewing and burning sen-sation on eating spicy foods.
(b) Restricted mouth opening and changes in the oral mucous mem-brane including the presence of palpable vertical fibrous bands, stiffness and blanching.
|
|
ExclusionCriteria |
Details |
Individuals with other associated oral mucosal lesions or systemic diseases, systemic conditions like pregnancy, lactating mother and those not willing for follow-up. |
|
Method of Generating Random Sequence
|
Random Number Table |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
The outcome of both the drugs will be compared |
4 weeks |
|
Secondary Outcome
|
Outcome |
TimePoints |
1.The OSMF will be graded clinically according to the classification of Ranganathan et al
2.The mouth opening will be measured with a Vernier Caliper between the incisal tips of both the arches
3.Burning sensation will be gauged based on Visual Analogue Scale ranging from 0- 10
4.The degree of protrusion of tongue will be recorded in millimeters from the incisal edge of the lower teeth to the tip of tongue.
5.Palpatory findings will be recorded as positive when a lack of suppleness and palpable fibrous bands or marked stiffness will be evident for the areas of the right and left buccal mucosa, lips and floor of mouth.
6.The site of the bands and its extent (including segmentation) in all the groups will be recorded at the initial visit and later compared with weekly interval using the criteria: 1 as Improved, 0 no change and -1 as worsen
|
Recalled every week for 4 Weeks |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
08/12/2022 |
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="0" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response (Others) - Relevant if any
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report Response (Others) - NIL
- Who will be able to view these files?
Response (Others) - NIL
- For what types of analyses will this data be available?
Response (Others) - NIL
- By what mechanism will data be made available?
Response (Others) - NIL
- For how long will this data be available start date provided 15-06-2023 and end date provided 18-10-2028?
Response (Others) - WILL BE UPDATED LATER
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
|
1.
The study will include 60 patients diagnosed with OSMF. Based upon the
previous investigations the present sample size was established.
2.
Detailed case history will be documented and complete information about
the study protocol, necessary follow-up required will be explained and a signed
informed consent will be obtained from each patient.
3.
Lycopene 16 mg in two equally divided doses and serratiopeptidase 30 mg in three equally
divided doses will be given for 4 weeks.
4.
After establishing the diagnosis for OSMF simple randomization will be
done by registering the patients as they come in the OPD and serial number
starting from 1 will be assigned to the patients.
5.
The study will be double blinded. Blinding of the drugs as well as the
investigators will be done and third person who is not part of the study will
assign the drug to the patients.
6.
Blinding of the drug will be done by wrapping a paper around the drugs
and by marking them as A and B.
7.
Drug A will be assigned to even numbers and drug B will be assigned to
odd numbers.
8.
When the drug finishes the third person will assign the required drug
to the patients.
9.
Patients will be evaluated and followed-up in a weekly interval for a
period of four weeks.
10.
The clinical examination will be carried out at every recall visit and
the clinical findings will be recorded with the parameters like mouth opening,
burning sensation, tongue protrusion and the palpatory findings.
11.
The paper on the drug will be
opened after 4 weeks.
Data
will be tabulated and statistical analysis will be done to get the comparative
results of the two drugs. |