A randomized, double-blind, placebo parallel controlled clinical trial of Shuanghua Baihe Tablets in the treatment of recurrent aphthous ulcer

Phase 4

• Conditions: Recurrent aphthous ulcer

• Registration Number: ITMCTR2000003541
• Lead Sponsor: Peking University School and Hospital of Stomatology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) Meet the diagnostic criteria for recurrent aphthous ulcer;
(2) The clinical classification is mild recurrent oral ulcer;
(3) The course of the disease should not exceed 48 hours, and no treatment has been performed;
(4) Aged 18-65 years, male or female.

Exclusion Criteria

(1) Patients with other obvious painful lesions that may affect the observation of curative effect, such as: patients with pericoronitis, acute pulpitis, acute apical inflammation and other diseases;
(2) Having used analgesics, antibiotics, anti-inflammatory drugs 48 hours before the study, and having used corticosteroids, immunomodulators and other western medicines with the same or similar effects within three months;
(3) Those who are accompanied by other diseases, such as the circulatory system, endocrine system, digestive system, malignant tumors, and autoimmune diseases;
(4) Patients with severe cardiovascular, cerebrovascular, severe cardiopulmonary insufficiency, liver, kidney, hematopoietic system and other serious primary diseases, diseases, mental disorders, and intellectual disabilities;
(5) People with allergies and a history of allergies to drugs and food;
(6) Pregnant and intentional pregnancy women or lactating women;
(7) Those who have participated in clinical trials within the past three months;
(8) The investigator believes that it is not suitable to participate in clinical trials.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
lcer healing rate;Ulcer healing time;Safety evaluation;Pain score;Ulcer size;