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

Evaluation of efficacy of bee pollen in treatment of oral submucous fibrosis patients: A randomized clinical drug trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/02/031377
Enrollment
96
Registered
2021-02-17
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K135- Oral submucous fibrosis

Interventions

Intervention1: Bee pollen: 500mg BD for 3 months Control Intervention1: lycopene: 2000 mcg OD for 3 months

Sponsors

Dr Divya Dube
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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 patientsTimepoint: 3 months

Secondary

MeasureTime frame
to compare the efficacy of bee pollen with that of lycopene in subsiding the symptoms of oral submucous fibrosisTimepoint: 3 months

Countries

India

Contacts

Public ContactDr Apeksha Dhole Balpande

VSPM Dental college and research centre

apekshadhole15@gmail.com9975549889

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026