| CTRI Number |
CTRI/2021/02/031377 [Registered on: 17/02/2021] Trial Registered Prospectively |
| Last Modified On: |
07/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical drug trial to study the effectiveness of bee pollen capsules in patients suffering from oral submucous fibrosis. |
|
Scientific Title of Study
|
Evaluation of efficacy of bee pollen in treatment of oral submucous fibrosis patients: A randomized clinical drug 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 Divya Dube |
| Designation |
Postgraduate student |
| Affiliation |
VSPM Dental college and research centre |
| Address |
VSPM Dental college and research centre hingna road Digdoh hills police nagar nagpur
Department of Oral Medicine and Radiology
Nagpur
MAHARASHTRA
440030
India |
| Phone |
7030388551 |
| Fax |
|
| Email |
dubey18divya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Apeksha Dhole Balpande |
| Designation |
Professor and PG Guide |
| Affiliation |
VSPM Dental college and research centre |
| Address |
VSPM Dental college and research centre hingna road Digdoh hills police nagar nagpur
Department of Oral Medicine and Radiology
Nagpur
MAHARASHTRA
440010
India |
| Phone |
9975549889 |
| Fax |
|
| Email |
apekshadhole15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Apeksha Dhole Balpande |
| Designation |
Professor and PG Guide |
| Affiliation |
VSPM Dental college and research centre |
| Address |
VSPM Dental college and research centre hingna road Digdoh hills police nagar nagpur
Department of Oral Medicine and Radiology
Nagpur
MAHARASHTRA
440010
India |
| Phone |
9975549889 |
| Fax |
|
| Email |
apekshadhole15@gmail.com |
|
|
Source of Monetary or Material Support
|
| VSPM Dental college and research centre, Nagpur |
|
|
Primary Sponsor
|
| Name |
Dr Divya Dube |
| Address |
39 gadage baba society beside shivaji complex new mankapur nagpur |
| Type of Sponsor |
Other [Self sponsored] |
|
|
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 DIVYA DUBE |
VSPM Dental college and research centre |
Department of Oral Medicine and Radiology
Nagpur
MAHARASHTRA |
7030388551
dubey18divya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe |
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 |
Bee pollen |
500mg BD for 3 months |
| Comparator Agent |
lycopene |
2000 mcg OD for 3 months |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Clinically diagnosed grade I. grade II, grade III, oral submucous fibrosis patients according to Khanna and Andrade (1995) classification.
2.Patients who has quit the habit of areca nut.
3.Patientsbelow 12 years of age and above 12 years of age.
4.Patients with visual analog scale (VAS) score below 6
5.Patients who were willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1.Individuals with history of treatment and undergoing treatment for oral submucous fibrosis.
2.Patients with any oral or systemic diseases and/or any medications
3.Patients diagnosed with grade IV cases of OSMF according to Khanna and Andrade classification.
4.Pregnant and lactating women.
5.Patients with VAS score above 6.
6.History of hypersensitivity to bee products or any other medications.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
efficacy of bee pollen in relieve of symptoms:
1. burning sensation
2. mouth opening
3. blanching
4. fibrous bands
of oral sub mucous fibrosis patients patients |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to compare the efficacy of bee pollen with that of lycopene in subsiding the symptoms of oral submucous fibrosis |
3 months |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
Final Enrollment numbers achieved (Total)= "96"
Final Enrollment numbers achieved (India)="96" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
22/02/2021 |
| Date of Study Completion (India) |
15/03/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Publised in -JOURNAL OF INDIAN ACADEMY OF ORAL MEDICINE AND RADIOLOGY |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study is randomized, parallel group, clinical drug trial evaluating the efficacy of bee pollen 500mg daily in two divided doses for 3 months and in patients with Oral submucous fibrosis; that will be conducted in central India Nagpur. The primary outcome of the study will measure the efficacy of bee pollen in subsiding the symptoms of oral submucous fibrosis (burning sensation, mouth opening, fibrous bands, blanching). The secondary outcome of the study will be to compare the efficacy of bee pollen with that of Lycopene in subsiding the symptoms of oral submucous fibrosis patients. |