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Efficacy and safety of matrine combined with diammonium glycyrrhizinate for the treatment of dermatitis and eczema-A randomized controlled clinical study

Efficacy and safety of matrine combined with diammonium glycyrrhizinate for the treatment of dermatitis and eczema-A randomized controlled clinical study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077249
Enrollment
Unknown
Registered
2023-11-02
Start date
2023-11-02
Completion date
Unknown
Last updated
2023-11-06

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

Conditions

dermatitis

Interventions

Matrine group:Oral oxymatrine tablets, 0.3g, 3 times a day
diammonium glycyrrhizinate group:Oral administration of diammonium glycyrrhetinic acid enteric coated capsules, 150mg, 3 times a day
combination group:Oral administration of matrine (0.3g, 3 times daily) and diammonium glycyrrhetate enteric coated capsules (150mg, 3 times daily)
conventional antihistamine drug group:Oral loratadine, 10mg, once daily

Sponsors

People's Hospital of Ningxia Hui Autonomous Region
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 65 Years

Inclusion criteria

Inclusion criteria: Patients who are diagnosed as moderate to severe dermatitis or eczema will be enrolled from our outpatient department from November 2023 to March 2024: Eczema area and severity index (EASI) score = 12 points, Body Surface Area (BSA) = 10%, Scoring atopic dermatitis severity score (SCORAD) score = 20 points, Investigator global assessment (IGA) score = 3 points, Numerical Rating Scale (NRS) Score = 6 points]. Patients are divided into adolescent (12-17 years old) and adult (18 years old and above) groups based on their age. The patient or guardian signs an informed consent form and voluntarily cooperates to complete the entire treatment and follow-up process. Normal individuals who come to our hospital for physical examination during the same period will be enrolled as the control group, including adolescents (12-17 years old) and adults (18 years old and above). The age, gender, and other baseline conditions of the controls are consistent with those of cases with dermatitis and eczema. As the control group, blood, urine, scurf, and other samples are collected and frozen at -80 ? for subsequent omics analysis.

Exclusion criteria

Exclusion criteria: (1) Previously allergic to drugs such as matrine or diammonium glycyrrhizinate; (2) Pregnant or lactating individuals; (3) Individuals with neurological or psychiatric disorders; (4) Individuals with immune deficiency, severe systemic diseases (such as heart, liver, kidney), or malignant tumors; (5) Patients with acute or active chronic infections who require systematic application of antibiotics and antiviral drugs within 2 weeks prior to enrollment and are currently receiving treatment with antiparasitic or antifungal drugs; (6) Individuals who have systematically applied hormones, immunosuppressants, small molecule targeted drugs, or biological agents within 4 weeks prior to enrollment; (7) According to the researcher's judgment, the guardians are unreliable or have poor compliance.

Design outcomes

Primary

MeasureTime frame
EASI-75;

Secondary

MeasureTime frame
EASI-90;Pruritus;Sleep improvement;

Countries

China

Contacts

Public ContactSong Hongbin

People's Hospital of Ningxia Hui Autonomous Region

1114213587@qq.com+86 157 1287 9198

Outcome results

None listed

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