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PsoriasisPhase 2NCT03942185

Chinese Herbal Medicine for Psoriasis Vulgaris: a Real World Study

A Phase 2 study testing Oral Chinese Herbal Medicine of Clearing heat and Cooling blood therapy, Oral Chinese Herbal Medicine according with syndrome differentiation therapy and Oral Chinese Herbal Medicine of Promoting blood circulation and Removing blood stasis therapy in people with Psoriasis, run by Shanghai Yueyang Integrated Medicine Hospital at 20 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 The sponsor has not verified this record for over two years, so it may be out of date.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 is to establish a multi-center clinical registration platform, to form the real world evidence of New Blood Syndrome Theory intervention in psoriasis, and to evaluate the therapeutic advantages of New Blood Syndrome Theory therapy in the clinical effective and recurrence rate of psoriasis… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Psoriasis
What is being tested?
Oral Chinese Herbal Medicine of Clearing heat and Cooling blood therapy, Oral Chinese Herbal Medicine according with syndrome differentiation therapy and Oral Chinese Herbal Medicine of Promoting blood circulation and Removing blood stasis therapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,000 participants
Where
20 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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • In line with the western and Chinese Medicine diagnosis standard of psoriasis vulgaris and Chinese Medicine syndrome diagnosis standard of psoriasis;
  • 18 to 65 years old, male or female patient;
  • The selected subjects cannot be selected or omitted until the pre-designed number of cases is completed;
  • Informed consent must be obtained.
  • Not in line with the western and Chinese Medicine diagnosis standard of psoriasis vulgaris and Chinese Medicine syndrome diagnosis standard of psoriasis;
  • 18 to 65 years old, male or female patient;
  • The selected subjects cannot be selected or omitted until the pre-designed number of cases is completed;
  • Informed consent must be obtained.

Who cannot join

  • Patients with a history of serious mental illness or family history;
  • Other reasons that the investigator considered inappropriate to participate in the study.
  • Other active skin diseases which may affect the condition assessment are present;
  • Those with severe, uncontrollable local or systemic acute or chronic infections;
  • Patients with a history of serious mental illness or family history;
  • Other reasons that the investigator considered inappropriate to participate in the study.

Trial locations and contacts

20 sites in 1 country.

Bin Li contact

008618930568129

18930568129@163.com

Xin Li contact

008613661956326

13661956326@163.com

20 sites in 1 country

China20 sites

  • Beijing Hospital of Traditional Chinese Medicine

    Beijing, Beijing Municipality

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

    Fuzhou, Fujian

  • The First Affiliated Hospital of Guiyang College of TCM

    Guiyang, Guizhou

  • Zhejiang Provincial Hospital of TCM

    Hangzhou, Zhejiang

  • First Affiliated Hospital of Heilongjiang Chinese Medicine University

    Harbin, Heilongjiang

  • The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

    Hefei, Anhui

  • Affiliated Hospital of Gansu University of traditional Chinese Medicine

    Lanzhou, Gansu

  • Chinese Medicine Hospital Affiliated to Southwest Medical University

    Luzhou, Sichuan

  • Affiliated hospital of jiangxi university of traditional Chinese medicine

    Nanchang, Jiangxi

  • The Second Affiliated Hospital of Jiangxi University of TCM

    Nanchang, Jiangxi

  • Jiangsu Province Hospital of Traditional Chinese Medicine

    Nanjing, Jiangsu

  • The Guangxi Zhuang Autonomous Region Institute of Dermatology and control

    Nanning, Guangxi

  • Changhai Hospital

    Shanghai, Shanghai Municipality

  • Shanghai 10th People's Hospital

    Shanghai, Shanghai Municipality

  • Shanghai Dermatology Hospital

    Shanghai, Shanghai Municipality

  • Shanghai Yueyang Integrated Medicine Hospital

    Shanghai, Shanghai Municipality

  • Shijiazhuang Hospital of Traditional Chinese Medicine

    Shijiazhuang, Hebei

  • Wuhan No.1 Hospital

    Wuhan, Hubei

  • Shanxi Provincial Hospital of Traditional Chinese Medicine

    Xi’an, Shanxi

  • The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

    Zhengzhou, Henan

Other trials in China

About this study

Official title: Chinese Herbal Medicine for the Treatment of Psoriasis Vulgaris: a Real World Study

The purpose of this study is to establish a multi-center clinical registration platform, to form the real world evidence of New Blood Syndrome Theory intervention in psoriasis, and to evaluate the therapeutic advantages of New Blood Syndrome Theory therapy in the clinical effective and recurrence rate of psoriasis vulgaris.

Read the detailed description

Psoriasis is a common chronic and recurrent inflammatory skin disease. The incidence of the disease is increasing year by year, seriously affecting people's quality of life. The systematic treatment of psoriasis in modern medicine is limited of wide application due to the adverse reactions of different degrees and the high economic cost.

Chinese Medicine (CM) has unique advantages in treatment of psoriasis. On the basis of CM principle--"Blood Differentiation and Treatment" in psoriasis and the combination of clinical experience, Chinese famous professor Wanzhang Qin proposed the "New Blood Syndrome Theory" in psoriasis--the psoriasis based in blood, with blood heat first, and blood stasis throughout the whole process of psoriasis. This study will form a systematic report on the diagnosis and treatment of psoriasis with the New Blood Syndrome Theory; theoretically verified by prospective cohort studies, a theoretical system of the New Blood Syndrome Theory for psoriasis will be constructed.

Objectives of this study are to establish a multi-center clinical registration platform, to form the real world evidence of New Blood Syndrome Theory intervention in psoriasis, and to evaluate the therapeutic advantages of New Blood Syndrome Theory therapy in the clinical effective and recurrence rate of psoriasis vulgaris.

Conditions
Psoriasis
Being tested
Oral Chinese Herbal Medicine of Clearing heat and Cooling blood therapy, Oral Chinese Herbal Medicine according with syndrome differentiation therapy, Oral Chinese Herbal Medicine of Promoting blood circulation and Removing blood stasis therapy
Keywords
Psoriasis Vulgaris, Chinese Medicine, Real World Study, Clearing heat and Cooling blood, Promoting blood circulation and Removing blood stasis
Medical subject headings
Psoriasis

What participants receive

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

  • Oral Chinese Herbal Medicine of Clearing heat and Cooling blood therapyDrug

    Oral Chinese Herbal Medicine of Clearing heat and Cooling blood therapy, warm water decoction, 1 dose/day, divided into 2 times, 180 ~ 200ml each time for 8 weeks.

  • Oral Chinese Herbal Medicine according with syndrome differentiation therapyDrug

    Oral Chinese Herbal Medicine according with syndrome differentiation therapy, warm water decoction, 1 dose/day, divided into 2 times, 180 ~ 200ml each time for 8 weeks.

  • Oral Chinese Herbal Medicine of Promoting blood circulation and Removing blood stasis therapyDrug

    Oral Chinese Herbal Medicine of Promoting blood circulation and Removing blood stasis therapy, warm water decoction, 1 dose/day, divided into 2 times, 180 ~ 200ml each time for 8 weeks.

Study groups in NCT03942185
Study groupRoleWhat they receive
Psoriasis with Blood heat syndrome groupExperimentalParticipants in Psoriasis with Blood heat syndrome group will receive Chinese Herbal Medicine internal treatment according with the Chinese Medicine principle of Clearing heat and Cooling blood, such as Cool blood detoxification Decoction I，Cool blood and activating blood prescription compound, Cool blood detoxification Decoction II, Cool blood activating blood Decoction, Tufu drink, Xiaoyin Decoction and etc., two times per day for 8 weeks.
Receives: Drug: Oral Chinese Herbal Medicine of Clearing heat and Cooling blood therapy
Psoriasis with Blood stasis syndrome groupExperimentalParticipants in Psoriasis with Blood stasis syndrome group will receive Chinese Herbal Medicine internal treatment according with the Chinese Medicine principle of Promoting blood circulation and Removing blood stasis, such as Huoxue Sanyu Xiaoyin Decoction, Cool blood detoxification Decoction III and etc., two times per day for 8 weeks.
Receives: Drug: Oral Chinese Herbal Medicine of Promoting blood circulation and Removing blood stasis therapy
Psoriasis with Non-Blood heat or Blood stasis syndrome groupExperimentalParticipants in Psoriasis with Non-Blood heat or Blood stasis syndrome group will receive Chinese Herbal Medicine internal treatment according with the Chinese Medicine principle of syndrome differentiation therapy two times per day for 8 weeks.
Receives: Drug: Oral Chinese Herbal Medicine according with syndrome differentiation therapy
Healthy control groupNo interventionNo Intervention.

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. CM symptom score

    The CM 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
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03942185
Sponsor's protocol ID
2018YFC1705301
Status last verified
May 2019
First submitted
7 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

  • Sun X, Zhao H, Wang R, Li H, Wu Y, Ze K, Su Y, Li B, Li X. Psoriasis complicated with metabolic disorder is associated with traditional Chinese medicine syndrome types: a hospital-based retrospective case-control study. Curr Med Res Opin. 2023 Jan;39(1):19-25. doi: 10.1080/03007995.2022.2129803. Epub 2022 Oct 11.

    PubMed 36189747

  • Luo Y, Ru Y, Sun X, Zhou Y, Yang Y, Ma T, Xu R, Chen J, Zhou M, Ze K, Ju L, Wang Y, Yin Q, Wang R, Li B, Li X. Characteristics of psoriasis vulgaris in China: a prospective cohort study protocol. Ann Transl Med. 2019 Nov;7(22):694. doi: 10.21037/atm.2019.10.46.

    PubMed 31930095

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oral Chinese Herbal Medicine of Clearing heat and Cooling blood therapy, Oral Chinese Herbal Medicine according with syndrome differentiation therapy and Oral Chinese Herbal Medicine of Promoting blood circulation and Removing blood stasis therapy in people with Psoriasis, run by Shanghai Yueyang Integrated Medicine Hospital at 20 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 8 inclusion and 6 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 20 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 (008618930568129, 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 NCT03942185, 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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