| CTRI Number |
CTRI/2024/11/077144 [Registered on: 20/11/2024] Trial Registered Prospectively |
| Last Modified On: |
13/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effectiveness of Moringa Oliefera Capsules in Oral Sub Mucous Fibrosis. |
|
Scientific Title of Study
|
Comparative Evaluation of Effectiveness of Moringa Oliefera Capsules and Lycopene Capsules in the Management of Oral Submucous Fibrosis – A Randomized Controlled Trial.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M Kavinraj |
| Designation |
Post Graduate Student |
| Affiliation |
Government Dental College and Hospital Nagpur |
| Address |
Room No 25 Department of Oral Medicine and Radiology
Government Dental College and Hospital Nagpur Maharashtra.
Nagpur
MAHARASHTRA
440003
India |
| Phone |
8056903523 |
| Fax |
|
| Email |
kavinkr199810@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Amit R. Parate |
| Designation |
Associate Professor |
| Affiliation |
Government Dental College and Hospital Nagpur. |
| Address |
46 West Avenue 101 First floor Shivaji Nagar Nagpur 440010.
Nagpur
MAHARASHTRA
440003
India |
| Phone |
9370998219 |
| Fax |
|
| Email |
amit_parate11@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Kavinraj |
| Designation |
Post Graduate Student |
| Affiliation |
Government Dental College and Hospital Nagpur |
| Address |
Room No 25 Department of Oral Medicine and Radiology
Government Dental College and Hospital Nagpur Maharashtra
Nagpur
MAHARASHTRA
440003
India |
| Phone |
8056903523 |
| Fax |
|
| Email |
kavinkr199810@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College and Hospital Hanuman Nagar Nagpur 440003 Maharashtra. |
|
|
Primary Sponsor
|
| Name |
Dr M Kavinraj |
| Address |
Room No 25 Department of Oral Medicine and Radiology Government Dental College and Hospital Nagpur Maharashtra.
|
| Type of Sponsor |
Other [Self] |
|
|
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 |
| KAVINRAJ M |
Government Dental College and Hospital Nagpur |
Room No 25 department of oral Medicine and Radiology
Nagpur
MAHARASHTRA |
8056903523
kavinkr199810@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Government Dental College and hospital Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients fulfilling the Diagnostic criteria for Oral Sub Mucous Fibrosis. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Multivitamin capsules |
lycopene capsules 5 mg Per Day Orally BD |
| Comparator Agent |
Natural ayurvedic capsules |
Moringa oliefera capsules 500mg
Orally BD |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients in INTERINCISAL OPENING RANGE of 15-35mm. oral sub mucous fibrosis grade1,2,3 acc.to Khanna and Andrade classification (1995).
2.No history of prior treatment for the same.
3.Patient willing for habit cessation and visit the hospital for regular follow up.
|
|
| ExclusionCriteria |
| Details |
1.Patients with systemic disease.
2.Patients with trismus due to other reason (pericoronitis, abscess).
3.Presence of other premalignant lesion (leukoplakia, oral lichen planus) or malignancy.
4.History of hypersensitivity to moringa oliefera and its components.
5.Any tongue abnormalities and disorders.
6.Missing upper and lower central incisors
7.Pregnant and lactating mothers.
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Evaluation of the following Parameters
1.Maximal interincisal opening using Vernier Caliper.
2.Reduction of burning sensation on the VAS scale
3.Increase in tongue protrusion measured by using steel scale.
4.Cheek flexibility. |
Patients will be recalled at the end of 1st week ,2nd week ,4th week, at the end of 2nd month and 3rd month. Post treatment follow up will be done on monthly basis for three months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| side effects of intervention if any |
Patient will be recalled at the end of 1st week,
2nd week,
4th week,
At the end of 2nd month and
At the end of 3rd month.
Post Treatment follow up on monthly basis for three months.
|
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 2 |
|
Date of First Enrollment (India)
|
25/11/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Oral submucous fibrosis, till date having no definite treatment has been treated with various treatment modalities, which includes the use of various antioxidant and anti-inflammatory therapies. Of all the antioxidants tried in OSMF, lycopene has shown to be an effective antioxidant. There is high reactivity between the long polyene chain and free radicals which enables the elimination of singlet oxygen and the reduction of reactive oxygen species (ROS). But long term use of lycopene may cause lycopenemia, which manifests as deposition of lycopene in liver and orange discolouration of skin. Therefore, newer modalities are needed to be tried in chronic inflammatory conditions like OSMF. Moringa oliefera is a mineral and vitamin rich nutritious and medicinally important tree species. Moringa leaves also has potent antioxidant activity, due to phenolic compounds and flavonoids in it. Oral submucous fibrosis, till date having no definite treatment has been treated with various treatment modalities, which includes the use of various antioxidant and anti-inflammatory therapies. Considering these properties, Moringa oliefera can be considered in the management of OSMF. Also comparing it with lycopene, an effective antioxidant, would further help in better understanding its potential in the management of OSMF. |