| CTRI Number |
CTRI/2020/10/028530 [Registered on: 21/10/2020] Trial Registered Prospectively |
| Last Modified On: |
05/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Treatment response of spirulina, omega-3 fatty acid and Vitamin E & C in OSMF |
|
Scientific Title of Study
|
Clinical Correlation, Response to Treatment & Immunoexpression With Cross Talk Between c-JUN & TGF-β in Oral Submucous Fibrosis & Oral Cancer |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ritu Garg |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Room no. 1, Department of Oral Medicine and Radiology, Maulana Azad Institute of Dental Sciences, Mirdard Marg, LNJP Colony, Bahadur Shah Zafar Marg, New Delhi 110002
Central
DELHI
110002
India |
| Phone |
9650174491 |
| Fax |
|
| Email |
ritu2706@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunita Gupta |
| Designation |
Head of Department |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Room no. 10, Department of Oral Medicine and Radiology, Maulana Azad Institute of Dental Sciences, Mirdard Marg, LNJP Colony, Bahadur Shah Zafar Marg, New Delhi 110002
Central
DELHI
110002
India |
| Phone |
9650174491 |
| Fax |
|
| Email |
drsunitagupta@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ritu Garg |
| Designation |
Post Graduate Student |
| Affiliation |
Maulana Azad Institute of Dental Sciences |
| Address |
Maulana Azad Institute of Dental Sciences, Mirdard Marg, LNJP Colony, Bahadur Shah Zafar Marg, New Delhi 110002
Central
DELHI
110002
India |
| Phone |
9650174491 |
| Fax |
|
| Email |
ritu2706@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of oral Medicine & Radiology, Maulana Azad Institute of Dental Sciences, New Delhi- 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Institute of Dental Sciences |
| Address |
Mirdard Marg,LNJP Colony, BSZ Marg, New Delhi-110002 |
| Type of Sponsor |
Government 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 |
| Dr Ritu Garg |
Maulana Azad Institute of Dental Sciences |
Room No. 1, OPD, Ground Floor, Department of Oral Medicine & Radiology
Central
DELHI |
9650174491
ritu2706@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MAIDS 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 |
Capsule Omega-3 fatty acid |
Capsule Omega-3 fatty acid orally 1gm twice daily for 6 months. |
| Comparator Agent |
Capsule Vitamin C and Vitamin E |
Capsule Vitamin C (500 mg) and Vitamin E (400IU) orally once daily for 6 months |
| Intervention |
Tablet Spirulina 500 mg |
Tablet Spirulina orally 500 mg twice daily for 6 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Clinically and histopathologically proven cases of OSMF
Restricted mouth opening |
|
| ExclusionCriteria |
| Details |
Patient not willing for participation
Patient with severe systemic disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Mouth Opening, Tongue Protrusion, Cheek Flexibility, VAS Scale |
Pre treatment, 1 month, 3 months and at the end of 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reporting of any malignant transformation in the span of 6 months |
Every 4 weeks till 6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
21/10/2020 |
| Date of Study Completion (India) |
31/10/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| 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)?
Response - NO
|
|
Brief Summary
|
This double blind, randomized parallel group trial will be conducted on patient with Oral Submucous Fibrosis. After inclusion and exclusion criteria, 60 patients are enrolled in the study which will be randomized in 3 equal groups of 20 patients each ( Group A1, A2, and A3). Group A1 will receive Tab Spirullina (500 mg twice daily for 6 months). Group A2 will be given Cap Omega 3 Fatty acid (1 gm twice daily for 6 months) and group A3 will receive Cap Vit. C 500 mg and Vit. E 400 IU (both twice daily for 6 months). Regular follow will be done at the end of each month upto 6 months. |