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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035206
Enrollment
Unknown
Registered
2020-08-03
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-08-10

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

Conditions

Recurrent aphthous ulcer

Interventions

Sponsors

Peking University School and Hospital of Stomatology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
Ulcer size;Ulcer healing rate;Pain score;Ulcer healing time;Safety evaluation;

Countries

China

Contacts

Public ContactHong Hua

Peking University School and Hospital of Stomatology

honghua1968@aliyun.com+86 010-82195806

Outcome results

None listed

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