| CTRI Number |
CTRI/2025/07/091159 [Registered on: 18/07/2025] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Pilot Study on the Use of Moringa Leaf Extract to Improve Symptoms in People with Oral Submucous Fibrosis |
|
Scientific Title of Study
|
Evaluation of efficacy of Moringa leaves extract in treatment of Oral Submucous Fibrosis in comparison with standard treatment protocol – A Randomised Controlled 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 Tapasya Karemore |
| Designation |
Associate Professor |
| Affiliation |
Ranjeet Deshmukh Dental College and Research centre, Digdoh hills, Higna road, NAGPUR |
| Address |
Ranjeet Deshmukh Dental College and Research centre, Digdoh hills, Higna road, NAGPUR
Nagpur
MAHARASHTRA
440019
India |
| Phone |
08830081564 |
| Fax |
|
| Email |
drtapasyavk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tapasya Karemore |
| Designation |
Associate Professor |
| Affiliation |
Ranjeet Deshmukh Dental College and Research centre, Digdoh hills, Higna road, NAGPUR - 440019 |
| Address |
Ranjeet Deshmukh Dental College and Research centre, Digdoh hills, Higna road
Nagpur
MAHARASHTRA
440019
India |
| Phone |
08830081564 |
| Fax |
|
| Email |
drtapasyavk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Poonam Ambhore |
| Designation |
Postgraduate Student (MDS – Oral Medicine and Radiology) |
| Affiliation |
Ranjeet Deshmukh Dental College and Research centre, Digdoh hills, Higna road, NAGPUR |
| Address |
Ranjeet Deshmukh Dental College and Research centre, Digdoh hills, Higna road, NAGPUR
Nagpur
MAHARASHTRA
440019
India |
| Phone |
08830081564 |
| Fax |
|
| Email |
poonam4997@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Poonam Ambhore |
| Address |
Ranjeet Deshmukh Dental College and Hospital, Nagpur |
| Type of Sponsor |
Other [Self-funded postgraduate researcher] |
|
|
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 Poonam Ambhore |
Ranjeet Deshmukh Dental College and Hospital, Digdoh hills , Higna 440019 |
Department of Oral Medicine and Radiology
Nagpur
MAHARASHTRA |
08830081564
poonam4997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ranjeet Deshmukh Dental College & Research Ethics 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 |
control group |
SM-FIBRO (OD) + Turbocort gel (TID)
|
| Intervention |
standard drug + intervention |
Moringa Tablet (1000 mg OD) + SM-FIBRO (OD) + 4% Moringa gel (TID)
|
| Intervention |
Standard drug + Intervention drug |
Moringa Powder (2 g in water OD) + SM-FIBRO (OD) + 4% Moringa gel (TID)
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically diagnosed OSMF Stage I to III by Khanna and Andrade classification
2. History of areca nut, gutkha, kharra, pan masala chewing
3. Willing to participate and give informed consent
|
|
| ExclusionCriteria |
| Details |
1. Habit cessation in the last 6 months
2. Stage IV OSMF
3. Systemic illness or medications
4. Allergy to Moringa or herbal drugs
5. Already undergoing treatment for OSMF
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
Change in clinical parameters (burning sensation, mouth opening, tongue protrusion, cheek flexibility)
|
from baseline to Day 30 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Sustained improvement in symptoms at 1-month follow-up after treatment completion
|
Baseline, day 10, day 20, day 30 , follow up after 1 month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
28/07/2025 |
| 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="2"
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
|
This pilot study aims to assess the efficacy of Moringa oleifera leaf extract in different forms (tablet, powder, and 4% gel) in the management of Oral Submucous Fibrosis (OSMF). A total of 30 clinically diagnosed patients will be randomly divided into three groups and treated for 30 days. Group I will receive Moringa tablets + SM-FIBRO + Moringa gel, Group II will receive Moringa powder + SM-FIBRO + Moringa gel, and Group III (control) will receive SM-FIBRO + Turbocort gel. Clinical improvements in burning sensation, mouth opening, tongue protrusion, and cheek flexibility will be evaluated at baseline, Day 10, Day 20, and Day 30, followed by a 1-month follow-up.
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