A study to compare the effectiveness of naringenin with lycopene versus lycopene with placebo in patients with Oral Submucous Fibrosis for improving mouth opening and symptoms.

Comparative Evaluation of Effectiveness of Naringenin as an Adjuvant with Lycopene and Lycopene in the Management of Oral Submucous Fibrosis-A Randomized Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/05/111121

Enrollment

Registered

2026-05-26

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

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: Naringenin capsule and lycopene capsule and physiotherapy: Naringenin capsule 500 mg administered orally after meal twice daily (BD) for 2 months. + Lycopene capsule 5 mg administ

Eligibility

Inclusion criteria

Inclusion criteria: 1-Patients clinically diagnosed with Oral Submucous Fibrosis (OSMF), aged between 20 and 50 years. 2-Patients presenting with an interincisal mouth opening between 26mm to 35mm that is OSMF stage 2.(Followed as per classification given by Khanna and Andrade 1995) 3-Patients with no previous history of medical or surgical treatment for OSMF. 4-Patients who are willing to discontinue the causative habit(s) and adhere to regular follow-up visits throughout the study period.

Exclusion criteria

Exclusion criteria: 1-Patients with systemic illness or any medical condition that may interfere with the study. 2-Presence of other oral potentially malignant disorders such as leukoplakia or oral lichen planus or any oral malignancy. 3-Known allergy or hypersensitivity to Naringenin, Lycopene or related compounds. 4-Patients with tongue abnormalities or neuromuscular disorders affecting tongue movement. 5-Patients with missing upper and lower central incisors making interincisal measurement unreliable.

Design outcomes

Primary

Measure	Time frame
1. Maximal interincisal opening(mm) 2. Reduction of burning sensation on the VAS scale 3. Tongue protrusion (mm) 4. Cheek flexibility (mm)Timepoint: RECALL SCHEDULE 1 BASELINE 2 AFTER 15 DAYS 3 AT END OF 1 MONTH 4 AT THE END OF 2 MONTH (END OF TREATMENT) 5 AT THE END OF 3 MONTH	—

Secondary

Measure	Time frame
1. Side effects of intervention, if any reported by patient.Timepoint: RECALL SCHEDULE 1 BASELINE 2 AFTER 15 DAYS 3 AT END OF 1 MONTH 4 AT THE END OF 2 MONTH (END OF TREATMENT) 5 AT THE END OF 3 MONTH	—

Countries

India

Contacts

Public ContactDr Anurag Pramodrao Age

Government Dental College and Hospital Nagpur

amit_parate11@rediffmail.com9370998219

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026