Psoriasis VulgarisPhase 2NCT03942198
Oral Chinese Herbal Medicine for Psoriasis Vulgaris With Blood Stasis Syndrome
A Phase 2 study testing Taodan Granules in people with Psoriasis Vulgaris, run by Shanghai Yueyang Integrated Medicine Hospital at 5 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Taodan Granules
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 216 participants
- Where
- 5 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
- 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.
Who cannot join
- 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;
- 2 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;
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
First Affiliated Hospital of Heilongjiang Chinese Medicine University
Harbin, Heilongjiang
Affiliated hospital of jiangxi university of traditional Chinese medicine
Nanchang, Jiangxi
Shanghai Yueyang Integrated Medicine Hospital
Shanghai, Shanghai Municipality
Shijiazhuang Hospital of Traditional Chinese Medicine
Shijiazhuang, Hebei
Shanxi Provincial Hospital of Traditional Chinese Medicine
Xi’an, Shanxi
About this study
Official title: Oral Chinese Herbal Medicine for Psoriasis Vulgaris With Blood Stasis Syndrome: a Randomised, Double-blind, Doubledummy, Multicentre Clinical Trial
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.
Read the 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
- Being tested
- Taodan Granules, Taodan Granules Placebo
- Keywords
- Plaque psoriasis, Promoting blood circulation for removing blood stasis, Randomized controlled trial, Taodan Granules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taodan GranulesDrug
Also called Chinese Herbal Medicine
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.
Taodan Granules PlaceboDrug
Also called Chinese Herbal Medicine
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.
| Study group | Role | What they receive |
|---|---|---|
| Oral Chinese medicine | Experimental | Participants in experimental group will receive Taodan granule two times daily after meals three times per week for 8 weeks. Receives: 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. Receives: Drug: Taodan Granules Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 56 days after treatment
Secondary outcomes (6)
Body surface area (BSA)
The percentage of body surface area (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
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
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
Patient-reported quality of life (PRQoL)
Patient-reported quality of life (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
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
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.
- First posted8 May 2019
- Study start1 Jun 2019 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Yueyang Integrated Medicine Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shaanxi Hospital of Traditional Chinese Medicine, The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, Shijiazhuang Hospital of Traditional Chinese Medicine, Heilongjiang University of Chinese Medicine
- Responsible party
- Sponsor
- Investigators
- Jia Zhou, Study chair, Department of dermatology, Shanghai Yueyang Integrated Medicine Hospital, Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03942198
- Sponsor's protocol ID
- 2018YFC1705303-01
- 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
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.
PubMed 31700924
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Chinese Herbal Medicine for Psoriasis Vulgaris With Blood Stasis Syndrome: a Randomised, Double-blind, Doubledummy, Multicentre Clinical Trial
- ClinicalTrials.gov ID
- NCT03942198
- Acronym / sponsor ID
- 2018YFC1705303-01
- Conditions
- Psoriasis Vulgaris
- Keywords
- Plaque psoriasis, Promoting blood circulation for removing blood stasis, Randomized controlled trial, Taodan Granules
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Shanghai Yueyang Integrated Medicine HospitalUniversity, hospital or other
- Collaborators
- Shaanxi Hospital of Traditional Chinese Medicine, The Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, Shijiazhuang Hospital of Traditional Chinese Medicine, Heilongjiang University of Chinese Medicine
- Study start
- 1 Jun 2019 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 8 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral Chinese medicine | Experimental | Drug: Taodan GranulesParticipants in experimental group will receive Taodan granule two times daily after meals three times per week for 8 weeks. |
| Oral Chinese medicine placebo | Placebo comparator | Drug: Taodan Granules PlaceboParticipants in placebo group will receive Taodan granule two times daily after meals three times per week for 8 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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;
- 2 weeks of treatment with topical glucocorticoids, phototherapy, etc.;
- During severe, uncontrollable local or systemic acute or chronic infections;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Taodan GranulesAlso: Chinese Herbal MedicinePut 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. | Drug | Oral Chinese medicine |
| Taodan Granules PlaceboAlso: Chinese Herbal MedicinePut 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. | Drug | Oral Chinese medicine placebo |
Primary outcome
Psoriasis area and severity index (PASI)
Time frame: Up to 56 days after treatment
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.
6 secondary outcomes
Body surface area (BSA)
Time frame: Up to 56 days after treatment
Physician Global Assessment (PGA)
Time frame: Up to 56 days after treatment
Dermatology Life quality index(DLQI)
Time frame: Up to 56 days after treatment
Patient-reported quality of life (PRQoL)
Time frame: Up to 56 days after treatment
Visual Analogue Score (VAS)
Time frame: Up to 56 days after treatment
TCM symptom score
Time frame: Up to 56 days after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2019.
- Derived from this study: PubMed 31700924Ru 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jia Zhou study chair
Department of dermatology, Shanghai Yueyang Integrated Medicine Hospital, Shanghai
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Taodan Granules in people with Psoriasis Vulgaris, run by Shanghai Yueyang Integrated Medicine Hospital at 5 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 5 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. Some participants in this study may receive a placebo. 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 (PASI) (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 NCT03942198, which also lists 1 linked publication.
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.