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YXBCM01(PSORI-CM01) granules for psoriasis vulgaris: a randomised double-blind, double-dummy, controlled clinical study

YXBCM01(PSORI-CM01) granules for psoriasis vulgaris: a randomised double-blind, double-dummy, controlled clinical study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14005185
Enrollment
Unknown
Registered
2014-08-08
Start date
2014-08-08
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

psoriasis vulgaris

Interventions

intervention group:PSORI-CM 01 granules+Yinxieling placebo tablets
control group:yinxieling tablets+PSORI-CM 01 placebo granules

Sponsors

Guangdong Provincial Hosptial of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Patients with psoriasis vulgaris; (2) male or female patient between 18 to 65 years old; (3) PASI more than 3 and less than 30, and BSA less than 30%; (4) Informed consent.

Exclusion criteria

Exclusion criteria: (1) Psoriatic lesions can only be seen on face, scalp, nails, balanus, mucus and palmarplantar areas; (2) Acute progressive psoriasis, and erythroderma tendency; (3) Pregnant, lactating, or those who plan to become pregnant in a year; (4) SAS more than 50 or SDS more than 53, or with other psychiatric disorders; (5) With history of primary cardiovascular, respiratory, digestive, urinary, endocrinologic and hematologic diseases, which cannot be controlled through ordinary treatments. Those who with malignant diseases, infections, electrolyte imbalance, acid-base disturbance. Patients with clinical test results listed below: AST or ALT 3 times more than normal upper limit; Creatinine 1.5 times more than normal upper limit; Hemoglobin elevates 20g/L more than normal upper limit; Platelet count less than 75.0*10^9/L; White blood cell less than 3.0*10^9/L; Or any other abnormal laboratory test results, assessed by investigators, that are not suitable for this clinical study; (6) Allergic to any medicine or ingredients used in this study; (7) Participating other clinical trials or participated within 1 month. (8) Topical treatments with corticosteroids or Retinoic acid within 2 weeks; systemic therapy or phototherapy (UVB and PUVA) within 4 weeks; biological therapy within 12 weeks. (9) Patients need systemic treatment with western medicine.

Design outcomes

Primary

MeasureTime frame
Difference of psoriasis area and severity index (PASI) reducing;

Secondary

MeasureTime frame
improvement rate of PASI;visual analogue scale;body surface area;Dermatology Life Quality Index;

Countries

China

Contacts

Public ContactLu Chuanjian
luchuanjian888@vip.sina.com+86 13822250116

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 25, 2026