Systemic Lupus ErythematosusPhase 2/3NCT04275193
The Safety and Efficacy of Zishenqing in Subjects With Active Systemic Lupus Erythematosus
A Phase 2/3 study testing Zishenqing in people with Systemic Lupus Erythematosus, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
Trial summary
This study evaluates the safety and efficacy of the traditional chinese medicine Zishenqing in the treatment of active systemic lupus erythematosus. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Zishenqing
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteChina
- Study dates
- 22 Oct 2019to 1 Sep 2022
- Phase
- Phase 2/3
- 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
- Patients who qualify for the diagnosis of systemic lupus erythematosus according to the American college of rheumatology's 1997 revised classification criteria for systemic lupus erythematosus;
- For inpatient or out-patient with good compliance, sign the informed consent before the test;
- Sledai score during screening period≤10;
- Maintain a stable standard treatment regimen for at least 30 days before the first day (that is, the date of administration of the intervention drug). Standard treatment regimens refer to the stable use of any of the following (alone or in combination): corticosteroids, hydroxychloroquine, non-steroidal anti-inflammatory drugs, other immunosuppressants or immunomodulators (including azathioprine, mycophenolate ester, cyclophosphamide, methotrexate, leflunomide, tacrolimus, cyclosporine);
Who cannot join
- Severe lupus nephritis requiring hemodialysis or high-dose glucocorticoid treatment in the last 2 months;
- Central nervous system diseases (including epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis) caused by SLE or non-SLE in the last 2 months;
- Patients with severe heart, liver and kidney diseases and disease history of important organs, blood and endocrine system;
- Evaluation criteria of severity:
- Alanine aminotransferase(ALT) and Aspartate aminotransferase(AST)≥3 times the upper limit of normal;
- Glomerular filtration rate(GFR)<30ml/min;
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- White Blood Cell(WBC)<2.0×10^9/l;
- Platelet(PLT)<50×10^9/l;
- Immunodeficiency, uncontrolled infection and active or recurrent peptic ulcer;
- Pregnant and lactating women;
- Anaphylaxis: allergic to traditional Chinese medicine;
- The investigator considered it inappropriate to participate in this study;
- Participate in other clinical trials during the screening period.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200030
Jianchun Mao, master, 86-18917763231, mjcct2018@163.com
About this study
Official title: The Safety and Efficacy of the Traditional Chinese Medicine Zishenqing in Subjects With Active Systemic Lupus Erythematosus
This study evaluates the safety and efficacy of the traditional chinese medicine Zishenqing in the treatment of active systemic lupus erythematosus.
Read the detailed description
This study will be a multicenter, randomized, double-blind, placebo parallel controlled clinical trial with a course of 12 weeks.
- Multicenter: During the study period, it will be decided whether to increase the improvement progress of the research unit according to whether it will be difficult to join the group and the overall progress, so as to complete the clinical study on time in accordance with the research plan.
- Random scheme: In this study, a dynamic random variance minimization random scheme will be adopted. Considering the two influencing factors of SLEDAI score and complement level, the DAS for Interactive Web Response System(IWRS) will be used to calculate and distribute random numbers and dispensing drugs.
- Control drug: Placebo will be used as control in this trial.
- Blind method: The Zishenqing simulator will be prepared by double-blind design, the dosage form, appearance, size, color and smell will be consistent with the experimental drug, and the test process will be in a double-blind state.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Zishenqing, Placebo
- Keywords
- Safety, Efficacy, Systemic Lupus Erythematosus
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZishenqingDrug
Also called Zishenqingqi
Zishenqing Granule
PlaceboDrug
Also called Placebo(for Zishenqing)
Granule manufactured to mimic Zishenqing(containing 10% composition)
| Study group | Role | What they receive |
|---|---|---|
| Zishenqing | Experimental | The original treatment and Zishenqing 1Co by mouth,twice a day for 12 weeks Receives: Drug: Zishenqing |
| Placebo | Placebo comparator | The original treatment and Zishenqing simulator 1Co by mouth,twice a day for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lupus Quality of Life (LupusQoL)
Self reported the quality of life in patients with systemic lupus erythematosus.LupusQoL is made up of five parts((physical health, pain, planning, emotional health, and fatigue) and has a total of 34 questions.Each question is scored0-4,yielding a total between 0 and 136.
Measured: 12weeks
Secondary outcomes (2)
The 36-item shot form health survey(SF-36)
As a concise health questionnaire, SF-36 comprehensively summarizes the quality of life of the subjects from eight aspects: physiological function, physiological function, physical pain, general health status, energy, social function, emotional function and mental health.
Measured: 12weeks
Systemic lupus erythematosus disease activity index(SLEDAI)
SLEDAI scores are used to determine the activity of SLE.SLEDAI consists of 24 clinical and laboratory projects with different weights（0:no activity;1-5:mild activity;6-10:moderate activity;11-19:severe activity;≥20:extremely severe activity).
Measured: 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start22 Oct 2019
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- RenJi Hospital
- Responsible party
- Principal investigator, maojianchun, Shanghai University of Traditional Chinese Medicine
- Investigators
- Liangjing Lv, Ph.D, Study chair, RenJi HospitalHuanru Qu, Ph.D, Study chair, Longhua HospitalZhujing Zhu, Ph.D, Study chair, Longhua HospitalRuru Guo, Ph.D, Study chair, RenJi HospitalZhongping Xu, Master, Study chair, Longhua Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04275193
- Sponsor's protocol ID
- Zishenqing
- Status last verified
- Apr 2020
- First submitted
- 12 Feb 2020
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of the Traditional Chinese Medicine Zishenqing in Subjects With Active Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT04275193
- Acronym / sponsor ID
- Zishenqing
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Safety, Efficacy, Systemic Lupus Erythematosus
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- RenJi Hospital
- Study start
- 22 Oct 2019 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 19 Feb 2020 (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.
This study evaluates the safety and efficacy of the traditional chinese medicine Zishenqing in the treatment of active systemic lupus erythematosus.
Detailed description
This study will be a multicenter, randomized, double-blind, placebo parallel controlled clinical trial with a course of 12 weeks.
- Multicenter: During the study period, it will be decided whether to increase the improvement progress of the research unit according to whether it will be difficult to join the group and the overall progress, so as to complete the clinical study on time in accordance with the research plan.
- Random scheme: In this study, a dynamic random variance minimization random scheme will be adopted. Considering the two influencing factors of SLEDAI score and complement level, the DAS for Interactive Web Response System(IWRS) will be used to calculate and distribute random numbers and dispensing drugs.
- Control drug: Placebo will be used as control in this trial.
- Blind method: The Zishenqing simulator will be prepared by double-blind design, the dosage form, appearance, size, color and smell will be consistent with the experimental drug, and the test process will be in a double-blind state.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zishenqing | Experimental | Drug: ZishenqingThe original treatment and Zishenqing 1Co by mouth,twice a day for 12 weeks |
| Placebo | Placebo comparator | Drug: PlaceboThe original treatment and Zishenqing simulator 1Co by mouth,twice a day for 12 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)
- Patients who qualify for the diagnosis of systemic lupus erythematosus according to the American college of rheumatology's 1997 revised classification criteria for systemic lupus erythematosus;
- For inpatient or out-patient with good compliance, sign the informed consent before the test;
- Sledai score during screening period≤10;
- Maintain a stable standard treatment regimen for at least 30 days before the first day (that is, the date of administration of the intervention drug). Standard treatment regimens refer to the stable use of any of the following (alone or in combination): corticosteroids, hydroxychloroquine, non-steroidal anti-inflammatory drugs, other immunosuppressants or immunomodulators (including azathioprine, mycophenolate ester, cyclophosphamide, methotrexate, leflunomide, tacrolimus, cyclosporine);
Key exclusion criteria (13 listed)
- Severe lupus nephritis requiring hemodialysis or high-dose glucocorticoid treatment in the last 2 months;
- Central nervous system diseases (including epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis) caused by SLE or non-SLE in the last 2 months;
- Patients with severe heart, liver and kidney diseases and disease history of important organs, blood and endocrine system;
- Immunodeficiency, uncontrolled infection and active or recurrent peptic ulcer;
- Pregnant and lactating women;
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 |
|---|---|---|
| ZishenqingAlso: ZishenqingqiZishenqing Granule | Drug | Zishenqing |
| PlaceboAlso: Placebo(for Zishenqing)Granule manufactured to mimic Zishenqing(containing 10% composition) | Drug | Placebo |
Primary outcome
Lupus Quality of Life (LupusQoL)
Time frame: 12weeks
Self reported the quality of life in patients with systemic lupus erythematosus.LupusQoL is made up of five parts((physical health, pain, planning, emotional health, and fatigue) and has a total of 34 questions.Each question is scored0-4,yielding a total between 0 and 136.
2 secondary outcomes
The 36-item shot form health survey(SF-36)
Time frame: 12weeks
Systemic lupus erythematosus disease activity index(SLEDAI)
Time frame: 12weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2020.
- Individual participant dataSharing planned: No
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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.
Liangjing Lv, Ph.D study chair
RenJi Hospital
Huanru Qu, Ph.D study chair
Longhua Hospital
Zhujing Zhu, Ph.D study chair
Longhua Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Zishenqing in people with Systemic Lupus Erythematosus, run by Shanghai University of Traditional Chinese Medicine at 1 site 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 13 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 28 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Jianchun Mao, Master (+8618917763231, mjczyczx@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lupus Quality of Life (LupusQoL) (time frame: 12weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Apr 2020.