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Plaque PsoriasisPhase 2NCT03941431

Sequential Treatment of Psoriasis With Integrated Traditional Chinese and Western Medicine

A Phase 2 study testing Jueyin granules, moving cupping therapy and NB-UVB therapy in people with Plaque Psoriasis, run by Shanghai Yueyang Integrated Medicine Hospital at 6 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study was to explore intervention time of Chinese medicine and specification of a sequential treatment plan for severe psoriasis with Chinese and Western medicine. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Plaque Psoriasis
What is being tested?
Jueyin granules, moving cupping therapy and NB-UVB therapy
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
378 participants
Where
6 sitesChina
Study dates
1 Jun 2019to 31 Dec 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Plaque psoriasis, the course of disease is not limited.
  • Skin lesions involving ≤ 15% BSA (the lesions are mainly located in the trunk and / or limbs, palm / sole, face / scalp, vulva area is not included).
  • 18 to 65 years old, male or female patient.
  • Informed consent must be obtained.

Who cannot join

  • other active skin diseases which may affect the condition assessment are present.
  • Patients who received systematic treatment of research drugs, biological agents and immunosuppressive agents within 2 months.
  • Patients who received treatment with topical glucocorticoids, phototherapy, etc. within 2 weeks.
  • Those with severe, uncontrollable local or systemic acute or chronic infections.
  • patients with severe systemic diseases; or clinical test indicators in one of the following cases: alanine transferase or glutamate transferase increased by >1.5 times the upper limit of normal; serum creatinine increased by >1.5 times the upper limit of normal Any of the main blood routine indicators (white blood cell count, red blood cell count, hemoglobin amount, platelet count) below the lower limit of normal; or other laboratory abnormalities judged by the investigator are not suitable for participation in this trial.
  • Patients with a history of malignant tumors and patients with primary or secondary immunodeficiency and hypersensitivity.
Show all 12Show fewer
  • Patients underwent major surgery within 8 weeks or will require such surgery during the study period.
  • Patients who are pregnant or in lactation.
  • Those have a history of alcohol abuse, drug abuse or drug abuse.
  • Patients with a history of serious mental illness or family history.
  • Patients with a family history of cancer.
  • Other reasons that the investigator considered inappropriate to participate in the study.

Trial locations and contacts

6 sites in 1 country.

Bin Li contact

0086-021-55981301

18930568129@163.com

Xiaoying Sun contact

0086-021-65161782-3137

dr_xiaoying@126.com

6 sites in 1 country

China6 sites

  • The Second People's Hospital Affiliated to Fujian University of TCM

    Fuzhou, Fujian

    Ning Huang

  • Chinese Medicine Hospital Affiliated to Southwest Medical University

    Luzhou, Sichuan

    Wenxin Yang

  • Jiangsu Province Hospital of Traditional Chinese Medicine

    Nanjing, Jiangsu

    Yuegang Wei

  • Shanghai Dermatology Hospital

    Shanghai

    Yangfeng Ding

  • Shanghai Yueyang Integrated Medicine Hospital

    Shanghai

    Bin Li

  • Wuhan No.1 Hospital

    Wuhan, Hubei

    Xiaoyong Zhou

Other trials in China

About this study

Official title: Optimally Sequential Treatment of Integrated Chinese and Western Medicine for Psoriasis: a Multicenter Randomized Controlled Trial

The purpose of this study was to explore intervention time of Chinese medicine and specification of a sequential treatment plan for severe psoriasis with Chinese and Western medicine.

Read the detailed description

Psoriasis is a chronic, relapsing, inflammatory disease that seriously affects the quality of life of patients. Both Chinese medicine and Western medicine have many methods for treating psoriasis, each with its own advantages and disadvantages, but the pursuit of green and effective treatment programs is still the focus of the work of specialists and researchers. How to combine the existing safe and effective Chinese and Western medicine methods organically, and to achieve the purpose of improving efficacy under the premise of ensuring safety, is the motivation for carrying out this research.

The treatments involved in this study include cupping, phototherapy, and Chinese medicine. All three methods have sufficient literature to confirm their effectiveness in treating plaque psoriasis. The research team hopes to obtain a best combination of three treatments for plaque psoriasis by using a multicenter, randomized, single-blind, controlled trial.

Being tested
Jueyin granules, moving cupping therapy, NB-UVB therapy, Jueyin placebo granules, moving cupping placebo therapy
Keywords
Plaque Psoriasis, Jueyin granule, Moving cupping, NB-UVB, combination of Chinese traditional and Western medicine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Jueyin granulesDrug

    Also called Chinese Herbal Medicine

    Jueyin granules p.o. once a day for 8 weeks.

  • moving cupping therapyDevice

    Moving cupping therapy three times per week for 8 weeks.

  • NB-UVB therapyDevice

    NB-UVB phototherapy three times per week for 8 weeks.

  • Jueyin placebo granulesDrug

    Also called Chinese Herbal Medicine

    Jueyin placebo granules p.o. once a day for 8 weeks.

  • moving cupping placebo therapyDevice

    Moving cupping placebo therapy three times per week for 8 weeks.

  • NB-UVB placebo phototherapyDevice

    NB-UVB placebo phototherapy three times per week for 8 weeks.

Study groups in NCT03941431
Study groupRoleWhat they receive
Chinese medicine internal treatment groupExperimentalParticipants in Chinese medicine internal treatment group will receive Jueyin granule two times daily after meals and moving cupping placebo therapy three times per week for 8 weeks.
Receives: Drug: Jueyin granules; Device: moving cupping placebo therapy
Chinese medicine external treatment groupExperimentalParticipants in Chinese medicine internal treatment group will receive Jueyin placebo granule two times daily after meals and moving cupping therapy three times per week for 8 weeks.
Receives: Device: moving cupping therapy; Drug: Jueyin placebo granules
Chinese medicine treatment groupExperimentalParticipants in Chinese medicine treatment group will receive Jueyin granule two times daily after meals, moving cupping therapy and NB-UVB placebo therapy three times per week for 8 weeks.
Receives: Drug: Jueyin granules; Device: moving cupping therapy; Device: NB-UVB placebo phototherapy
Western medicine treatment groupExperimentalParticipants in Western medicine treatment group will receive Jueyin placebo granules two times daily after meals, moving cupping placebo therapy and NB-UVB therapy three times per week for 8 weeks.
Receives: Device: NB-UVB therapy; Drug: Jueyin placebo granules; Device: moving cupping placebo therapy
Integrated Chinese and Western Medicine Treatment GroupExperimentalParticipants in Chinese and Western Medicine Treatment Group will receive Jueyin granules two times daily after meals, moving cupping therapy and NB-UVB therapy three times per week for 8 weeks.
Receives: Drug: Jueyin granules; Device: moving cupping therapy; Device: NB-UVB therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Psoriasis area and severity index

    Psoriasis Area and Severity Index 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.

    Measured: Up to 56 days after treatment.

Secondary outcomes (6)

  1. Body surface area (BSA)

    The percentage of BSA involved in psoriasis is estimated by fingerprinting, where the entire palm of the patient represents approximately 1% of the total BSA. The number of handprints on psoriasis skin in a body part is used to determine the extent to which the body part is affected by psoriasis (%)

    Measured: Up to 56 days after treatment.

  2. Physician Global Assessment (PGA)

    Physician Global Assessment (PGA) is scored on a 5-point scale, reflecting a global consideration of the erythema (E), infiltration (I), desquamation (D) across all psoriatic lesions. It is calculated as follows: PGA score = (E + I + D) / 3, then the score needs to be rounded to the nearest whole number [PGA scale: Clear (0) - Very Severe (5)].

    Measured: Up to 56 days after treatment.

  3. Dermatology Life quality index(DLQI)

    The Dermatology Life Quality Index (DLQI) is a participant-reported questionnaire used to measure the health-related quality of life (QOL) of adults suffering from a skin disease. Scores range from 0-30, a higher score indicating a greater impact on a participant's quality of life.

    Measured: Up to 56 days after treatment.

  4. Patient-reported quality of life (PRQoL)

    PRQoL is used to assess the impact of psoriasis on individual social life. Scores range from 0-25, a higher score indicating a greater impact on a participant's social life.

    Measured: Up to 56 days after treatment.

  5. Visual Analogue Score (VAS)

    Visual Analog Scale (VAS) is used to measure lesion pruritus from 0 to 100 mm at eash visit (with 0 being no pruritis and 100 being maximum pruritis).

    Measured: Up to 56 days after treatment.

  6. TCM symptom score

    The TCM symptom score is used to assess changes in blood syndrome related symptoms during treatment.

    Measured: Up to 56 days after treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2019
  2. Study start1 Jun 2019 (estimated)
  3. Primary completion31 Dec 2021 (estimated)
  4. Study completion31 Dec 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
378 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03941431
Sponsor's protocol ID
2018YFC1705304
Status last verified
May 2019
First submitted
1 May 2019
Last updated
8 May 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Yu Y, Sun X, Hu R, Xia P, Wei Y, Yang W, Huang N, Ding Y, Guo S, Yang C, Weng H, Zhang Y, Ding X, Huang Q, Zhou X, Li X, Li B. A Randomized Controlled Trial for the Optimal Implementation of Psoriasis Treatment by Integrating Chinese and Western Medicine. Psoriasis (Auckl). 2025 Mar 21;15:55-66. doi: 10.2147/PTT.S487536. eCollection 2025.

    PubMed 40135074

  • Sun X, Zhou X, Wei Y, Yang W, Huang N, Ding Y, Hu R, Guo S, Yang C, Weng H, Zhang Y, Chen X, Ding X, Liu L, Yin Q, Wang R, Li X, Li B. Our Choice: study protocol for a randomized controlled trial for optimal implementation of psoriasis treatment by the integration of Chinese and western medicine. Trials. 2020 Mar 30;21(1):299. doi: 10.1186/s13063-020-4209-3.

    PubMed 32228720

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Jueyin granules, moving cupping therapy and NB-UVB therapy in people with Plaque Psoriasis, run by Shanghai Yueyang Integrated Medicine Hospital at 6 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 8 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Bin Li (0086-021-55981301, 18930568129@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Psoriasis area and severity index (time frame: Up to 56 days after treatment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03941431, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2019.

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