Pilot Study of Traditional Chinese Medicine (Qing-Re-Liang-Xue Decoction) as Complementary Medicine for Psoriasis Vulgaris of Blood-heat Syndrome.

NCT04994951 | Unknown Phase 2 DMC

• 1 other identifier: 2021-KLJ-001-02
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Psoriasis is a non-contagious erythematous scaly skin disease characterized by epidermal proliferation and inflammation. The etiology is related to heredity, infection, allergies, metabolic disorders and autoimmunity. The incidence of psoriasis in the survey was about 1.2‰ in 1984 in China, and 2.6% in the United States. In recent years, the incidence of psoriasis has been on the increase trend, mostly in the young to middle age adults, and it can last a lifetime. The characteristic of the disease is that it usually spreads all over the body, or gradually aggravates, or is fixed and difficult to subside,or the disease course is long, lingering and difficult to heal, and it brings great harm to the patient's body and mind. At present, there is no effective treatment for psoriasis. Although western medicine has good short-term curative effects, prolonged use is not advocated because of adverse side effects and poor long-term effects. Besides, it is easy to relapse and aggravate after stopping the medicine. Psoriasis belongs to the category of "baibi" in Chinese medicine. Doctors of the past dynasties mostly treated it from blood heat, blood stasis, and blood deficiency syndrome. Researcher Zhu Renkang believes that "blood with heat" is the main cause of psoriasis and famous TCM dermatologists such as Zhang Zhili, Gu Bohua, Xu Yihou and others all regard "blood-heat syndrome" as the basic pathogenesis of psoriasis. We used Qingre Liangxue Recipe Granules to observe the treatment of 31 patients with blood-heat type psoriasis vulgaris, and found that the PASI index of the patients after treatment was significantly lower than before treatment (P \<0.01), and the serum VEGF level was significantly decreased (P \< 0.01), the correlation analysis between the two showed a significant correlation. This study aims to further evaluate the efficacy and safety of Qing-Re-Liang-Xue Decoction in comparison with commonly used glucocorticoids and calcipotriol ointment in patients with blood-heat type psoriasis vulgaris.

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

• participants achieving either a major clinical response or partial clinical response defind by Psoriasis Area Severity Index (PASI) over the 10 weeks treatment period.

  Psoriasis Area Severity Index (PASI) is usually used to measure the clinical activity diseases of psoriasis.

  10 weeks

Secondary Outcomes (3)

• Changes in skin lesions are assessed by dermoscope.

  10 weeks.

• Evaluation of curative effect of Traditional Chinese medicine is assessed by patient reported outcome(PRO) and clinician reported outcomes(CRO).

  10 weeks.

• Compliance evaluation is assessed by Counting Days of Treatment.

  10 weeks.

Study Arms (2)

Qing-Re-Liang-Xue Decoction.

EXPERIMENTAL

One dose of granules is mixed, poured into 500ml of boiling water, and taken twice in the morning and afternoon. Women stop taking Chinese medicine during the first 3 days of menstruation. Triamcinolone Acetonide Acetate and Urea Cream,10g/tube and Calcipotriol Ointment,10g/tube are used alternately. The period of treatment will be 10 weeks.

Drug: Qing-Re-Liang-Xue Decoction.

control group

ACTIVE COMPARATOR

Topical steroids. Triamcinolone Acetonide Acetate and Urea Cream,10g/tube and Calcipotriol Ointment,10g/tube are used alternately. The period of treatment will be 10 weeks.

Drug: Triamcinolone Acetonide Acetate and Urea Cream.

Interventions

Triamcinolone Acetonide Acetate and Urea Cream. DRUG

10g/tube and CalcipotriolOintment,10g/tube are used alternately.

control group

Qing-Re-Liang-Xue Decoction. DRUG

One dose of granules is mixed, poured into 500ml of boiling water, and taken twice in the morning and afternoon. Women stop taking Chinese medicine during the first 3 days of menstruation.The period of treatment will be 10 weeks.

Qing-Re-Liang-Xue Decoction.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years;
• Had a diagnosis of psoriasis vulgaris for ≥6 months;
• TCM syndrome evaluation belongs to blood-heat type patients: it is more common in the advanced stage of psoriasis. Symptoms: skin lesions develop faster, skin lesions are bright red, blood loss is obvious, scales are dry and thick, itching is severe; upset, and thirsty, dry stool; red-purple tongue, yellow fur, string or slippery or rapid pulse;
• Patients without serious primary diseases, such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system or mental illnesses;
• Those who are willing to cooperate and can persist in the treatment without interruption;
• During the treatment period, those who have not taken or used other psoriasis drugs externally.

You may not qualify if:

• Patients with serious primary diseases, such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system or mental illnesses;
• History of immunosuppressant medication in the past three months;
• Those who use other drugs during treatment or stop treatment on their own and have incomplete observation data;
• Pregnancy or risk of pregnancy, and/or lactation;
• Aged ≤18 or ≥65 years old;
• Patients with other types of psoriasis, such as articular, pustular, and erythroderma.

Sponsors & Collaborators

• The First Affiliated Hospital of Zhejiang Chinese Medical University: lead
• Pujiang Hospital of Traditional Chinese Medicine: collaborator
• Yongkang Hospital of Traditional Chinese Medicine: collaborator
• Ningbo Hospital of Traditional Chinese Medicine: collaborator
• Wenzhou Hospital of Integrated Traditional Chinese and Western Medicine: collaborator

Study Sites (1)

First Affiliated Hospital of Zhejiang Chinese Medical University

Hangzhou, Zhejiang, 310006, China

RECRUITING

MeSH Terms

Interventions

Triamcinolone Acetonide

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

Yi Cao, Master

CONTACT

0571-87077785; caoyi1965@163.com

Xiaohong Yang

CONTACT

+86-15257128368; yangxiaohonghz@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: August 6, 2021
• Study Start: September 1, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2024
• Last Updated: August 6, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)