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A randomized controlled pilot study on the control of psoriasis relapse by dampness-eliminating decoction

A randomized controlled pilot study on the control of psoriasis relapse by dampness-eliminating decoction

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077929
Enrollment
Unknown
Registered
2023-11-23
Start date
2023-12-01
Completion date
Unknown
Last updated
2023-11-27

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

Conditions

psoriasis

Interventions

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age from 18-70 years 2. Psoriasis Area and Severity Index (PASI) score=10 or Body Surface Area (BSA) =10 3. Meet the requirement of using secukinumab; without the history of inflammatory bowel disease (IBD) 4. Written/signed informed consent

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women, or those who plan pregnancy during the study period. 2. Patients with inflammatory bowel disease (IBD) 3. Patients with severe primary diseases such as respiratory system and circulatory system that cannot be controlled by conventional medication; patients with severe infection, tuberculosis, hepatitis and other infectious history, lymphocyte proliferation, hematopoietic system abnormalities, tumor; patients with severe water, electrolyte and acid-base balance disorder; patients with primary or secondary immune deficiency and hypersensitivity. Or clinical test indicators are one of the following cases: alanine aminotransferase or glutamic oxaloacetic transaminase increase more than 3 times the upper limit of normal value; creatinine is higher than 1.5 times of the upper limit of normal value; creatinine more than 1.5 times of the upper limit of normal value; serological test of human immunodeficiency virus (HIV) is positive; Any main indicators of blood test is below the lower limit of normal; or patients are assessed as unsuitable for this trial by researchers through other abnormal laboratory tests. 4. Patients who are known to be allergic to the medication and its related ingredients used in this study and those with related medication ingredients. 5. Those who are participating in other medication clinical trials or have participated in other clinical trials within 4 weeks. 6. Those who used traditional Chinese medicine or Chinese Medicine products or external antibiotics within 2 weeks; those who used hormonal and other external medication or phototherapy within 4 weeks; those who had received methotrexate, cyclosporin A or oral antibiotics within 12 weeks; those who had received acitretin or biological agents within 24 weeks. 7. Patients are assessed as unsuitable for inclusion by the researchers.

Design outcomes

Primary

MeasureTime frame
the rate of relapse;

Secondary

MeasureTime frame
Time to relapse;The proportion of patients who achieve at least 75% improvement in PASI score from baseline;The proportion of patients who achieve at least 90% improvement in PASI score from baseline;The improvement in PASI score from baseline after treatment;Physician's global assessment (PGA) score;Pruritus Scores on the Visual Analogue Scale score;Dermatology Life Quality Index (DLQI);Patients' attitudes, expectation and experience;Skindex16;

Countries

China

Contacts

Public ContactChuanjian Lu

Guangdong Provincial Hospital of Chinese Medicine

lcj@gzucm.edu.cn+86 138 2225 0116

Outcome results

None listed

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