| CTRI Number |
CTRI/2025/07/090790 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
11/07/2025 |
| 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 Study To See How Effective Moringa Leaf Extract Is In Treating Oral Submucous Fibrosis Compared To Standard Treatment |
|
Scientific Title of Study
|
Evaluation of efficacy of moringa leaves extract in treatment of oral submucous fibrosis in comparison with standard treatment protocol - A randomized controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Poonam@4997 |
ClinicalTrials.gov |
|
|
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 |
9823420379 |
| Fax |
|
| Email |
drtapasyavk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Poonam Ambhore |
| Designation |
Post graduate student |
| 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 |
8830081564 |
| Fax |
|
| Email |
poonam4997@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Poonam Ambhore |
| Designation |
Post graduate student |
| 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 |
8830081564 |
| Fax |
|
| Email |
poonam4997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ranjeet Deshmukh Dental College and Research Centre, Digdoh hills, Higna Road Nagpur |
|
|
Primary Sponsor
|
| Name |
Poonam Ambhore |
| Address |
Ranjeet Deshmukh Dental College and Research Centre, Digdoh hills, Higna Road Nagpur |
| Type of Sponsor |
Private 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 Poonam Ambhore |
Department of Oral Medicine and Radiology |
RANJEET DESHMUKH DENTAL COLLEGE AND RESEARCH CENTRE DIGDOH HILLS HIGNA ROAD NAGPUR 440019
Nagpur
MAHARASHTRA |
8830081564
poonam4997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Ranjeet Deshmukh Dental College and Research Centre |
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 |
| Intervention |
group 1 - Moringa Tablet + Standard Treatment + 4% Moringa Gel |
Participants will receive 1000 mg Moringa oleifera tablets once daily, Cap. SM-FIBRO once daily, and 4% Moringa gel thrice daily, for 30 days.
|
| Intervention |
group 2 - Moringa Powder + Standard Treatment + 4% Moringa Gel |
Participants will receive 2 grams of Moringa oleifera powder mixed in water once daily, Cap. SM-FIBRO once daily, and 4% Moringa gel thrice daily, for 30 days.
|
| Intervention |
group 3 - Standard Treatment + 4% Moringa Gel |
Participants will receive Cap. SM-FIBRO once daily and 4% Moringa gel thrice daily, for 30 days.
|
| Comparator Agent |
group 4 - standard treatment only |
Participants will receive Cap. SM-FIBRO once daily, with no additional herbal or topical therapy, for 30 days.
|
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with clinically diagnosed Oral Submucous Fibrosis (OSMF) classified as
Stage II-III (based on classification of Khanna and Andrade – 1995)
2.Patients with known history of areca nut, gutkha, kharra, pan masala chewing.
3.Patients who are willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
1.Patients who have left the habit in the last 6 months or more.
2.Patients with OSMF Stage IV.
3.Patients with any systemic diseases.
4.Patients on any medications.
5.Patients with history of hypersensitivity to any drug or natural plants including
moringa.
6.Patients who are already under the treatment of 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 |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in clinical parameters of Oral Submucous Fibrosis including burning sensation on visual analogue scale, mouth opening, tongue protrusion, and cheek flexibility.
|
baseline, day 10, day 20, day 30, day 60
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Sustained improvement in clinical parameters during follow-up
|
3-month follow-up after Day 30
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
25/07/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/07/2025 |
| 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 Yet Recruiting |
| 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 randomized controlled trial aims to evaluate the efficacy of Moringa oleifera leaves extract in various forms (tablet, powder, and gel) in the treatment of Oral Submucous Fibrosis (OSMF), compared with a standard treatment protocol. A total of 80 clinically diagnosed Stage II–III OSMF patients will be randomly allocated into four groups. Group I will receive Moringa tablets with standard drugs and gel, Group II will receive Moringa powder with standard drugs and gel, Group III will receive standard drugs with Moringa gel only, and Group IV will receive only standard treatment. Clinical parameters including burning sensation, mouth opening, tongue protrusion, and cheek flexibility will be assessed at baseline, 10th, 20th, and 30th day, followed by a 3-month follow-up. This study explores the potential role of Moringa as a natural therapeutic agent in the management of OSMF.
|