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A clinical study of self-simulated Chinese herbal mouthwash in the treatment of immune-related recurrent oral ulcers

A clinical study of self-simulated Chinese herbal mouthwash in the treatment of immune-related recurrent oral ulcers

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083912
Enrollment
Unknown
Registered
2024-05-07
Start date
2024-05-10
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

immune-related recurrent oral ulcers

Interventions

control group1: treatment of mouth sores (such as oral cleaning)
control group2:On the basis of the blank control group, compound chlorhexidine gargle (containing chlorhexidine gluconate and metronidazole) was added twice a day, each gargle was 15ml, the time was 5
experimental group:On the basis of the blank control group, self-simulated traditional Chinese medicine mouthwash (6g of Bletillae Rhizoma, 6g of Galla Chinensis, 10g of Cynanchi Atrati Radix et Rhiz

Sponsors

Nanjing Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: a. be between the ages of 18 and 65 (both ends inclusive); b. meet the diagnostic criteria for oral ulcers, such as white or yellow ulcers on the oral mucosa, accompanied by pain and discomfort, etc.; c. a clear correlation between ulcers and immune abnormalities, such as the onset of ulcers is consistent with the appearance or worsening of immune abnormalities; d. have not used intermediate-acting or short-acting hormones for at least 1 week or long-acting hormones for 2 weeks, or if they have been treated with prednisone (dragon) (=10 mg/d) or equivalent hormones and immunodrugs, the dose should be stable for at least 30 days before entering the study and remain unchanged in subsequent treatments; e. voluntarily participate in the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: a. oral ulcers caused by other non-immune-related causes, such as drug-induced oral ulcers, traumatic oral ulcers, etc.; b. oral ulcers caused by oral cancer or other malignant tumors; c. pregnant women, lactating women, diabetic patients, patients with severe heart, liver and kidney insufficiency, mental illness or cognitive impairment, patients with allergies or allergies to the known ingredients of the study drug, patients with suspected or confirmed alcohol addiction, drug abuse history or other serious diseases; d.those who have participated in other clinical studies within 30 days before screening; e.patients who are unable to cooperate with the study or unwilling to sign the informed consent form

Design outcomes

Primary

MeasureTime frame
Classification of oral ulcers;Classification of ulcer pain;

Secondary

MeasureTime frame
Oral PH;Frequency of ulcer recurrence;Quality of life ;

Countries

China

Contacts

Public ContactXing Jiang

Nanjing University of Chinese Medicine/Nanjing Hospital of Traditional Chinese Medicine

jiangxing@njucm.edu.cn+86 153 6619 6186

Outcome results

None listed

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