临床试验/CTRI/2024/07/069828

CTRI/2024/07/069828招募中Phase 3 4

A Comparative study to assess the efficacy of topical Tulsi (Ocimum sanctum) and topical Lidocaine in the management of recurrent aphthous stomatitis (minor).

Anu M1 个研究点分布在 1 个国家目标入组 48 人开始时间: 2024年7月10日最近更新: 2025年5月22日

试验速览

阶段: Phase 3 4
状态: 招募中
发起方
入组人数: 48
试验地点: 1
主要终点: Reduction in size of the ulcer, intensity of pain

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is a randomized, parallel group trial comparing the efficacy of topical Tulsi and topical

Lidocaine in the management of recurrent aphthous stomatitis that will be conducted in Best Dental

Science College in India. The primary outcome will be reduction in size of the ulcer, intensity of pain

and degree of erythema which will be followed in day 1, 4 and 7 of using topical Tulsi and

Lidocaine.

研究设计

研究类型: Interventional
分配方式: Coin toss, Lottery, toss of dice, shuffling cards etc
盲法: Participant Blinded

入排标准

年龄范围: 18.00 Year(s) 至 30.00 Year(s)（—）
性别: All

入选标准

•Subjects giving a history of recurrent aphthous stomatitis-minor(ulcers that measure less then 10 mm, and heal within 4 to 14 days without scarring) with a minimum of two episodes in a year.
•Subjects with 1to 3 minor recurrent aphthous ulcers of less than 48 hours duration.

排除标准

•Subjects with any systemic disorders.
•Subjects with the habit of smoking or alcoholism.
•Subjects undergoing orthodontic therapy.
•Subjects who had undergone tooth extraction or any dental surgical procedure in the past 2 weeks.
•Pregnant and lactating women.

结局指标

主要结局

Reduction in size of the ulcer, intensity of pain

时间窗: Day 1,4 and 7 of using topical Tulsi and topical Lidocaine

and degree of erythema

时间窗: Day 1,4 and 7 of using topical Tulsi and topical Lidocaine

次要结局

Reduction in recurrences of the ulcer(Day 30 and 60)

研究者

发起方

Anu M

申办方类型

Other [self]

责任方

Principal Investigator

主要研究者

Anu M

Best Dental Science College

研究点 (1)

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