FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
  1. What data in particular will be shared?
    Response (Others) -  Relevant if any

  2. 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
  3. Who will be able to view these files?
    Response (Others) -  NIL

  4. For what types of analyses will this data be available?
    Response (Others) -  NIL

  5. By what mechanism will data be made available?
    Response (Others) -  NIL

  6. 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

  7. 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. 
Close