Comparing The Effect Of Herbal Extract With Gold Standard Drug For Treatment Of Homogenous Leukoplakia

Comparison of effectiveness of Calendula officinalis extract with Lycopene gel for treatment of tobacco induced Homogenous Leukoplakia â?? A Randomised clinical Trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/04/032895

Enrollment

Registered

2021-04-16

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- HOMOGENOUS LEUKOPLAKIA Health Condition 2: K132- Leukoplakia and other disturbancesof oral epithelium, including tongue

Interventions

Intervention1: Lycopene: lycopene gel containing lycopene antioxidant 2mg by weight, per ml of gel TID for 1 month Control Intervention1: Calendula Officinalis : Calendula officinalis extract gel cont

Eligibility

Inclusion criteria

Inclusion criteria: Tobacco induced, clinically diagnosed, histopathologically confirmed cases of homogeneous leukoplakia measuring not less than 1.5 cm in area bidimensionally. Age group 20 to 60 years. Patients willing to participate in the study.

Exclusion criteria

Exclusion criteria: Patients with potentially malignant disorders other than homogeneous leukoplakia. Past history of major illness within a period of 6 months. Patients with known allergy to Asterceae family Patients with known allergy to lycopene Pregnant and Lactating females.

Design outcomes

Primary

Measure	Time frame
Increase/decrease in the size of the lesionTimepoint: 1 and half year	—

Secondary

Measure	Time frame
No change in the size of lesionTimepoint: 1 and half year	—

Countries

India

Contacts

Public ContactManisha Singh

K.L.E.V.K Institute of dental sciences

anjanabagewadi455@gmail.com9620467333

Outcome results

None listed

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