comparing the vitamin A Cream with drumstick plant extract gel in treatment of oral potentially malignant disorder-leukoplakia

Completed

• Conditions: Malignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynx,

• Registration Number: CTRI/2020/10/028529
• Lead Sponsor: DrAnsari Sulem Riyaz Ahmed

Brief Summary

**Research summary**

**Aim:** The aim of the study is to evaluate & to compare the efficacy of Moringa oleifera leaf extract gel (2%) & Retino A cream (0.1%) in reduction of size of lesion in oral leukoplakia.

**Objectives :**

1.     To assess the efficacy of Moringa oleifera mucoadhesive gel in determining reduction in the size of the lesion in oral leukoplakia patient.

2.     To assess the efficacy of Retino-A cream in determining reduction in size of the lesion in oral leukoplakia patient.

3.     To compare the efficacy of Moringa oleifera mucoadhesive gel (2%) in determining the change in the size of the lesion in oral leukoplakia patient.

**Methodology :**

Clinically diagnosed cases of  Oral Leukoplakia will be included in this study. The sample size is 72. 36 patients with lesion size ranging from 2- 4 cm and 36 patients with lesion size ranging from 4.1 – 6 cm will be equally distributed in case and control group using chit system. So case and control both group will be having 36 patients with equal number of size range lesions.

The participants in case and control group will be advised topical application of     the intervention and Retino-A respectively thrice-daily using sterile cotton bud.

**Outcome :**

The participants will recalled for review after 1, 2, 3 months for evaluation of change in size of the lesion.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-12
• Last Update Posted: 2021-12-14
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• 1.Homogeneous leukoplakia of size range 2-6 cm in greatest dimension.
• 2.Patients above 18 years.
• 3.Patients who are willing to participate in this study.

Exclusion Criteria

• 1.Non-homogenous leukoplakia.
• 2.Leukoplakia more than 6 cm in greatest dimension.
• 3.Leukoplakia involving tongue and floor of oral cavity.
• 4.Patients with any other potentially malignant disorders other than Oral leukoplakia and under treatment.
• 5.Pregnant and lactating females.
• 6.Patients who have already undergone treatment for Oral Leukoplakia (within 3 months).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in the size of lesion of oral leukoplakia.	1,2,3 months

Secondary Outcome Measures

Name	Time	Method
Reduction in burning sensation	1,2,3 months

Trial Locations

Locations (1)

KLE VKIDS; 🇮🇳 Belgaum, KARNATAKA, India

KLE VKIDS

🇮🇳Belgaum, KARNATAKA, India

DrShivayogi Charantimath

Principal investigator

9739638971

cshivayogi@gmail.com