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ROLE OF COMBINATION OF AMLA AND TOPICAL ALOVERA GEL AS INTERVENTION IN PARTICIPANTS HAVING ORAL SUBMUCOUS FIBROSIS

COMPARATIVE EVALUATION OF EFFICACY OF COMBINATION OF LYCOPENE AND TOPICAL TRIAMCINOLONE ACETONIDE 0.1% V/S COMBINATION OF AMLA AND TOPICAL ALOVERA GEL IN THE MANAGEMENT OF ORAL SUBMUCOUS FIBROSIS A PROSPECTIVE, RANDOMISED CONTROL TRIAL - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/01/100031
Enrollment
40
Registered
2026-01-01
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-12

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: Amla Tab 500mg , topical aloe vera gel: Amla tab twice daily after meal and topical aloe vera gel thrice daily for 6 weeks and follow up for 2 weeks Control Intervention1: Lycopene caps

Sponsors

Dr Divya Tripathi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patients above 18 years of age. 2) Patients with no contraindications or documented allergies to the medication which are being used for the study. 3) Patients willing to give concent for the study. EXCLUSION CRITERION 1. Previously treated patients of OSMF in the last 3 months or those who have left treatment in between or undergoing any other treatment modality. 2. Patients clinically diagnosed with stage 4 of OSMF. 3. Pregnant and lactating mother 4. Physically challenged and syndromic patients. 5. Patients with any oral premalignant lesion or malignancies will be excluded from the study.

Exclusion criteria

Exclusion criteria: 1) Previously treated patients of OSMF in the last 3 months or those who have left treatment in between or undergoing any other treatment modality. 2) Patients clinically diagnosed with stage 4 of OSMF. 3) Pregnant and lactating mother 4) Physically challenged and syndromic patients. 5) Patients with any oral premalignant lesion or malignancies will be excluded from the study.

Design outcomes

Primary

MeasureTime frame
Burning sensation(Visual Analog Scale ), Mouth opening (Vernier caliper) Mucosal changes (pallor, ulceration, changes of tongue), Comparison of burning sensation, mouth opening and mucosal changes between the two groups ,Timepoint: after two weeks for 10 weeks

Secondary

MeasureTime frame
evaluate any side effects with both the treatment modalitiesTimepoint: after two weeks for 10 weeks

Countries

India

Contacts

Public ContactDr Divya Tripathi

Government Dental college and hospital , Mumbai

drvijayaomr@gmail.com9676557606

Outcome results

None listed

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