NCT03942198

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
216

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 8, 2019

Completed
24 days until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

May 8, 2019

Status Verified

May 1, 2019

Enrollment Period

2.6 years

First QC Date

May 7, 2019

Last Update Submit

May 7, 2019

Conditions

Psoriasis Vulgaris

Keywords

Plaque psoriasisPromoting blood circulation for removing blood stasisRandomized controlled trialTaodan Granules

Outcome Measures

Primary Outcomes (1)

  • Psoriasis area and severity index (PASI)

    Psoriasis Area and Severity Index (PASI) involves grading psoriatic plaques based on erythema (E), infiltration (I), desquamation (D). Severity is graded from 0-4 for each criteria (0 - none, 1 - slight, 2 - moderate, 3 - severe, and 4 - very severe). The body is divided into 4 regions, head, upper extremities, trunk, and lower extremities, and for each region, the surface area involvement is graded on a 0-6 scale (0 - 0% involvement, 1 - \<10%, 2 - 10-\<30%, 3 - 30-\<50%, 4 - 50-\<70%, 5 - 70-\<90%, 6 - 90-100%).The highest potential PASI score is 72, with higher PASI scores indicating worse psoriasis.

    Up to 56 days after treatment

Secondary Outcomes (6)

  • Body surface area (BSA)

    Up to 56 days after treatment

  • Physician Global Assessment (PGA)

    Up to 56 days after treatment

  • Dermatology Life quality index(DLQI)

    Up to 56 days after treatment

  • Patient-reported quality of life (PRQoL)

    Up to 56 days after treatment

  • Visual Analogue Score (VAS)

    Up to 56 days after treatment

  • +1 more secondary outcomes

Study Arms (2)

Oral Chinese medicine

EXPERIMENTAL

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

Drug: Taodan Granules

Oral Chinese medicine placebo

PLACEBO COMPARATOR

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

Drug: Taodan Granules Placebo

Interventions

Taodan GranulesDRUG

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.

Also known as: Chinese Herbal Medicine
Oral Chinese medicine
Taodan Granules PlaceboDRUG

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.

Also known as: Chinese Herbal Medicine
Oral Chinese medicine placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Comply with the diagnostic criteria of Western medicine for psoriasis and the diagnostic criteria for TCM syndromes;
  • 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);
  • Age between 18 and 65 years old;
  • Those who voluntarily participate in the study and sign informed consent.

You may not qualify if:

  • Patients with erythrodermic, arthritic, pustular or punctate psoriasis;
  • Other active skin diseases may affect the condition assessment;
  • Received research drugs, biological agents and immunosuppressive agents within 1 month;
  • weeks of treatment with topical glucocorticoids, phototherapy, etc.;
  • During severe, uncontrollable local or systemic acute or chronic infections;
  • 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;
  • A history of malignant tumors and patients with primary or secondary immunodeficiency and hypersensitivity;
  • Such surgery will be required during major surgery or study during 8 weeks;
  • Pregnant or lactating women;
  • A person with a history of alcohol abuse, drug abuse or drug abuse;
  • Have a history of serious mental illness or family history;
  • Other reasons researchers believe that it is inappropriate to participate in this research.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Shijiazhuang Hospital of Traditional Chinese Medicine

Shijiazhuang, Hebei, China

Location

First Affiliated Hospital of Heilongjiang Chinese Medicine University

Harbin, Heilongjiang, China

Location

Affiliated hospital of jiangxi university of traditional Chinese medicine

Nanchang, Jiangxi, China

Location

Shanghai Yueyang Integrated Medicine Hospital

Shanghai, Shanghai Municipality, China

Location

Shanxi Provincial Hospital of Traditional Chinese Medicine

Xi’an, Shanxi, China

Location

Related Publications (1)

  • 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.

    PMID: 31700924DERIVED

Study Officials

  • Jia Zhou

    Department of dermatology, Shanghai Yueyang Integrated Medicine Hospital, Shanghai

    STUDY CHAIR

Central Study Contacts

Bin Li

CONTACT

0086-021-5598130118930568129@163.com

Jie Chen

CONTACT

0086-021-65161782-3137dercj366@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2019

First Posted

May 8, 2019

Study Start

June 1, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

May 8, 2019

Record last verified: 2019-05

Locations

CN(5)