A clinical drug trial to study the effectiveness of bee pollen capsules in patients suffering from oral submucous fibrosis.

Phase 2

Completed

• Conditions: Oral submucous fibrosis,

• Registration Number: CTRI/2021/02/031377
• Lead Sponsor: Dr Divya Dube

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-22
• Study Completion: 2023-03-15
• Last Update Posted: 2024-07-02

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. burning sensation	3 months
efficacy of bee pollen in relieve of symptoms:	3 months
2. mouth opening	3 months
3. blanching	3 months
4. fibrous bands	3 months
of oral sub mucous fibrosis patients patients	3 months

Secondary Outcome Measures

Name	Time	Method
to compare the efficacy of bee pollen with that of lycopene in subsiding the symptoms of oral submucous fibrosis	3 months

Trial Locations

Locations (1)

VSPM Dental college and research centre; 🇮🇳 Nagpur, MAHARASHTRA, India

VSPM Dental college and research centre

🇮🇳Nagpur, MAHARASHTRA, India

DR DIVYA DUBE

Principal investigator

7030388551

dubey18divya@gmail.com