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Aloe vera in the treatment of Oral submucous fibrosis

Aloe vera as an adjuvant to lycopene in the treatment of Oral submucous fibrosis

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/01/011388
Enrollment
32
Registered
2018-01-17
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- oral submucous fibrosis

Interventions

Intervention1: Aloe vera juice, lycopene: Aloe vera 10ml. Patients instructed swish and swallow twice daily ,Lycopene 4mg to be taken twice daily for 2 months Intervention2: NIL: NIL Control Intervent

Sponsors

Coorg Institute Of Dental Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Patients above the age of 18 years 2.Male and female subjects diagnosed with OSMF according to the criteria by Warnakulasuriya et al. 3.A positive history of chewing of the areca nut or one of its commercial preparations 4.Patients who have not been on any treatment for OSMF for at least 2 months prior to their recruitment in the study

Exclusion criteria

Exclusion criteria: 1.Patients with mouth opening less than 15 mm 2.Patients with other coexisting mucosal lesions such as leukoplakia and malignancies. 3.The patients who have undergone radiotherapy of the head and neck 4.History of allergy to Aloe vera or Lycopene 5.History of systemic disorders like chronic liver disease, gastrointestinal disorders and patients on laxatives, diuretics and on medication for diabetes and cardiovascular disease. 6.Patients who are pregnant or lactating

Design outcomes

Primary

MeasureTime frame
to measure the improvement in VAS burning sensation and mouth openingTimepoint: baseline , 1 month, 2 month

Secondary

MeasureTime frame
To measure the improvement in tongue protrusion and cheek flexibilityTimepoint: Baseline, 1 month,2 month

Countries

India

Contacts

Public ContactNeha VijayaKumaran

Rajiv Gandhi University of Health Sciences

neha.vijay1@gmail.com9482938573

Outcome results

None listed

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