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Add-on Chinese herbal medicine external application (FZHFZY) to topical urea for mild-to-moderate psoriasis vulgaris: a pilot double-blind randomised controlled trial embedded with a qualitative study

Add-on Chinese herbal medicine external application to western therapy for psoriasis vulgaris: a pilot randomised controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200064092
Enrollment
Unknown
Registered
2022-09-26
Start date
2022-09-30
Completion date
Unknown
Last updated
2023-04-17

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

Conditions

Psoriasis Vulgaris

Interventions

The intervention group:Chinese herbal medicine external application (Fuzhenghefuzhiyang granules) plus topical urea cream
The control group:Placebo granules external application plus topical urea cream

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosed with psoriasis vulgaris 2. PASI < 10 or BSA < 10% 3. The age is between 18 and 65 years 4. Written informed consent is provided

Exclusion criteria

Exclusion criteria: 1. Currently are pregnant or lactating 2. Currently have uncontrolled or severe diseases, such as cardiovascular, respiratory, digestive, urinary, haematological or psychiatric diseases; have any known malignancy or a history of malignancy 3. Are allergic to the medications used in this study 4. Currently are participating in other clinical trial(s), or have participated in other clinical trial(s) in the previous month 5. Have not completed the required wash-out requirements of other psoriasis therapies as listed below: topical agents, antimicrobials, phototherapies, systemic nonbiologic therapies, and biologics.

Design outcomes

Primary

MeasureTime frame
Psoriasis Area and Severity Index (PASI);Trial feasibility;

Secondary

MeasureTime frame
At least 50% reduction from baseline PASI score;At least 75% reduction from baseline PASI score;Physician Global Assessment (PGA);Body Surface Area (BSA);Dermatology Life Quality Index (DLQI);Skindex-16;Itch visual analogue scale (VAS);The relapse rate;Safety assessments;

Countries

China

Contacts

Public ContactChuanjian Lu

Guangdong Provincial Hospital of Chinese Medicine

lcj@gzucm.edu.cn13822250116

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026