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PSORI-CMO2 granules, Yinxieling tablets for stable psoriasis vulgaris with syndrome pattern of blood stasis: a randomised double-blind, placebo-controlled clinical trial

PSORI-CMO2 granules, Yinxieling tablets for stable psoriasis vulgaris with syndrome pattern of blood stasis: a randomised double-blind, placebo-controlled clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-15006768
Enrollment
Unknown
Registered
2015-07-19
Start date
2015-07-19
Completion date
Unknown
Last updated
2022-10-24

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

Conditions

psoriasis vulgaris

Interventions

PSORI-CM02 granule group:PSORI-CM02 granule + Yinxieling tablet placebo
Yinxieling tablet group:Yinxieling tablets + PSORI-CM02 granule placebo
placebo group:Yinxieling tablet placebo + PSORI-CM02 granule placebo

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Patients with stable plaque psoriasis with syndrome pattern of blood stasis more than one year; 2.male or female patient between 18 to 65 years old; 3.PASI between 3 to 10, meanwhile BSA <= 10%; 4.Informed consent.

Exclusion criteria

Exclusion criteria: 1. Skin lesions manifest as droplets, or 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 can't 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 x 10^9/L; White blood cell less than 3.0 x 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
Improvement rate of PASI;time to relapse;rebound rate;

Secondary

MeasureTime frame
Psoriasis Area Severity Index;visual analogue scale;Body Surface Area;Dermatology Quality Life Index;Relapsing rate of treatment peroid and follow-up period;time of efficacy onset;

Countries

China

Contacts

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

Outcome results

None listed

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