Oral Chinese Herbal Medicine for Psoriasis Vulgaris With Blood Stasis Syndrome

NCT ID: NCT03942198

Last Updated: 2019-05-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2021-12-31

Brief Summary

We designed this study as a multicenter, randomized, double blinded and placebo-controlled clinical trial. The aim of the study is to evaluate the clinical efficacy, safety and control of recurrence rate of psoriasis with blood stasis syndrome.

Detailed Description

Psoriasis is a chronic, relapsing, inflammatory, multisystem disease characterized by infiltration of inflammatory cells, hyperplasia of epidermal keratinocytes, and abnormal differentiation. Latest data estimate that the prevalence of psoriasis in adults has increased to 11.43%, which shows that the control and treatment of psoriasis is still insufficient. Recent studies showed that traditional Chinese medicine (TCM) is one of the effective methods for the treatment of psoriasis. More and more evidences support the recognition of psoriasis not only affects the skin, but also suffers a chronic multisystem inflammation. In addition, blood-stasis accumulates in meridians, viscera and limbs to form a variety of syndromes with psoriasis for so long, which similar to many metabolic related diseases. Therefore, the method of promoting blood circulation and removing blood stasis has always been the focus of TCM treatment and prevention of psoriasis. This multicenter, randomized, double-blind, placebo-controlled trial will provide high-quality clinical evidences for evaluating the efficacy, safety and recurrence rate of Taodan granule, a representative prescription for the treatment of psoriasis with blood stasis syndrome, in the treatment of psoriasis.

Conditions

Psoriasis Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Oral Chinese medicine

Participants in experimental group will receive Taodan granule two times daily after meals three times per week for 8 weeks.

Group Type: EXPERIMENTAL

Taodan Granules

Intervention Type: DRUG

Put each bag of medicine in the same amount into the same container, pour about 50 ml of warm water, stir until the particles are basically dissolved, and then add appropriate amount of boiling water to dilute.

Oral Chinese medicine placebo

Participants in placebo group will receive Taodan granule two times daily after meals three times per week for 8 weeks.

Group Type: PLACEBO_COMPARATOR

Taodan Granules Placebo

Intervention Type: DRUG

Put each bag of medicine in the same amount into the same container, pour about 50 ml of warm water, stir until the particles are basically dissolved, and then add appropriate amount of boiling water to dilute.

Interventions

Taodan Granules

Put each bag of medicine in the same amount into the same container, pour about 50 ml of warm water, stir until the particles are basically dissolved, and then add appropriate amount of boiling water to dilute.

Intervention Type: DRUG

Taodan Granules Placebo

Put each bag of medicine in the same amount into the same container, pour about 50 ml of warm water, stir until the particles are basically dissolved, and then add appropriate amount of boiling water to dilute.

Intervention Type: DRUG

Other Intervention Names

Chinese Herbal Medicine; Chinese Herbal Medicine

Eligibility Criteria

Inclusion Criteria

1. Comply with the diagnostic criteria of Western medicine for psoriasis and the diagnostic criteria for TCM syndromes;

2. Skin lesions involve ≤10% BSA (the lesions are mainly located in the trunk and/or limbs, palm/sole, face/scalp, vulva area is not included);

3. Age between 18 and 65 years old;

4. Those who voluntarily participate in the study and sign informed consent.

Exclusion Criteria

1. Patients with erythrodermic, arthritic, pustular or punctate psoriasis;

2. Other active skin diseases may affect the condition assessment;

3. Received research drugs, biological agents and immunosuppressive agents within 1 month;

4. 2 weeks of treatment with topical glucocorticoids, phototherapy, etc.;

5. During severe, uncontrollable local or systemic acute or chronic infections;

6. Patients with severe systemic diseases; or clinical test indicators in one of the following conditions: alanine aminotransferase or aspartate aminotransferase increased by >1.5 times the upper limit of normal; creatinine increased by 1.5 times the upper limit of normal; blood routine indicators (white blood cell count) Any one of the red blood cell count, hemoglobin amount, and platelet count) is below the lower limit of normal; or other laboratory abnormalities are judged by the investigator to be unsuitable for participation in the trial;

7. A history of malignant tumors and patients with primary or secondary immunodeficiency and hypersensitivity;

8. Such surgery will be required during major surgery or study during 8 weeks;

9. Pregnant or lactating women;

10. A person with a history of alcohol abuse, drug abuse or drug abuse;

11. Have a history of serious mental illness or family history;

12. Other reasons researchers believe that it is inappropriate to participate in this research.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shaanxi Provincial Hospital of Traditional Chinese Medicine

UNKNOWN

Sponsor Role: collaborator

The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Shijiazhuang Hospital of Traditional Chinese Medicine

UNKNOWN

Sponsor Role: collaborator

Heilongjiang University of Chinese Medicine

OTHER

Sponsor Role: collaborator

Shanghai Yueyang Integrated Medicine Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jia Zhou

Role: STUDY_CHAIR

Department of dermatology, Shanghai Yueyang Integrated Medicine Hospital, Shanghai

Locations

Shijiazhuang Hospital of Traditional Chinese Medicine

Shijiazhuang, Hebei, China

First Affiliated Hospital of Heilongjiang Chinese Medicine University

Harbin, Heilongjiang, China

Affiliated hospital of jiangxi university of traditional Chinese medicine

Nanchang, Jiangxi, China

Shanghai Yueyang Integrated Medicine Hospital

Shanghai, Shanghai Municipality, China

Shanxi Provincial Hospital of Traditional Chinese Medicine

Xi’an, Shanxi, China

Countries

China

Central Contacts

Bin Li

Role: CONTACT

18930568129@163.com

0086-021-55981301

Jie Chen

Role: CONTACT

dercj366@163.com

0086-021-65161782-3137

References

Ru Y, Yan XN, Yang SQ, Gong LP, Li LE, Chen J, Zhao YD, An YP, Huang G, Zhang JF, Yin QF, Wang RP, Li X, Li B. Oral Taodan granules for mild-to-moderate psoriasis vulgaris: protocol for a randomized, double-blind, multicenter clinical trial. Ann Transl Med. 2019 Sep;7(18):488. doi: 10.21037/atm.2019.09.05.

Reference Type: DERIVED

PMID: 31700924 (View on PubMed)

Other Identifiers

2018YFC1705303-01

Identifier Type: -

Identifier Source: org_study_id