A Multi-center, randomized, double-blinded, double-dummy, parallel-controlled clinical trial to determine the efficacy and safety of Tripterygium Glycosides and Acitretin in patients with moderate to severe psoriasis vulgaris

Guideline-oriented Research in the Management of Some Common and Severe Skin Diseases

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-TRC-12003514

Enrollment

Unknown

Registered

2012-12-18

Start date

2011-08-01

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

severe psoriasis vulgaris

Interventions

TG treatment group:Take TG tablet every 2 slices,3 times a day,the placebo of Acitretin Capsules 3 pills on the noon once a day

Acitretin treatment group:Take the placebo of TG tablet every 2 slices,3 times a day,Acitretin Capsules 3 pills on the noon once a day

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Males and females aged between 18 and 75 years of age; 2. Moderate to severe psoriasis vulgaris defined by the following criteria: PASI >7 at screening and baseline; 3. Provide written informed consent; 4. Willing and able to comply with all aspects of the protocol.

Exclusion criteria

Exclusion criteria: 1. Other types of psoriasis than mild psoriasis vulgaris eg, guttate, pustular, erythodermic, etc; 2. Any clinically active skin diseases other than moderate to severe psoriasis vulgaris which might counter or influence the study aim; 3. Patients who used any of the following systemic treatments within 4 weeks before the Baseline visit eg: drugs for other studys, immuno-suppressive drugs, biologics; 4. Patients who used topical treatment within 2 weeks before the Baseline visit eg corticosteroids ultraviolet-light therapy including sunbathing , or liquor carbonis detergens; 5. Active infectious disease which was hard to control; 6. History of hepatitis B or hepatitis C, and advanced HIV infection; 7. Laboratory data such as alanine aminotransferase (ALT), aspartate aminotransferase (AST) and blood lipid profile was 1.5 times higher than the normal limits; 8. History of severe systemic disease or cancer; 9. Pregnant or lactating females or willing to pregnant in 2 years; 10. patients who has allergy of Tripterygium Glycosides and Acitretin any ingredient; 11. Any other situations not suitable for this study determined by the investigators.

Design outcomes

Primary

Measure	Time frame
PASI75;	—

Secondary

Measure	Time frame
PASI90;PASI50;	—

Countries

China

Contacts

Public ContactBaoxi Wang

wangbx@ncstdlc.org+86 025-85478071

Outcome results

None listed

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