Ankylosing SpondylitisPhase 4NCT04934059
Efficacy and Safety of Yuxuebi Tablet in Treating Night Pain of Ankylosing Spondylitis (AS).
A Phase 4 study testing Yuxuebi tablet in people with Ankylosing Spondylitis, run by China Resources Sanjiu Medical & Pharmaceutical Co., Ltd. at 5 sites in China.
Trial summary
This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of Yuxuebi tablet in treating night pain of Ankylosing Spondylitis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- Yuxuebi tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 5 sitesChina
- Study dates
- 1 Jul 2021to 31 Jan 2022
- Phase
- Phase 4
- 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
- Ages 18-65, male or female
- Confirmed diagnosis of Ankylosing Spondylitis
- Syndrome of traditional Chinese medicine is blood stasis syndrome
- ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score)≥2.1
- Visual analogue scale (VAS) for night pain≥4分
- Maintained stable doses of Sulfasalazine, Methotrexate, Leflunomide, etc. for more than 1 month if treating with Slow-Acting Antirheumatic Drugs
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- Maintained stable doses of biologics for more than 3 month if treating with biologics
- Not use Nonsteroidal Antiinflammatory Drugs within 2 weeks
- Patients who have not participated in other clinical trials within 4 weeks
- Written informed consent
Who cannot join
- Pregnant or breastfeeding or who expecting to conceive
- Psoriatic arthritis or Enteropathic arthritis
- AS with iritis or uveitis
- Abnormal liver function
- Abnormal kidney function，high level of Creatinine
- WBC (White Blood Cell)<3.0×10^9/L or with Hematological Disease
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- Patients with poor control of hypertension or diabetes
- Acute or chronic infectious diseases
- Severe arrhythmia
- Patients with malignant tumors or with a history of malignant tumors
- Drug allergy
- Patients who had taken Yuxuebi tablet for more than 4 weeks with poor outcome
- Patients who are treating with Traditional Chinese medicine for promoting blood circulation and removing blood stasis
- Alcohol or drug abuse
- Participants who are not suitable for clinical trial under doctors' consideration.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Guang'anmen Hospital
Beijing
Quan Jiang
The First People's Hospital of Guangzhou
Guangzhou
Xiaoyan Cai
The First People's Hospital of Jinzhong
Jinzhong
Tao Jiang
Nanchong Central Hospital
Nanchong
Shiquan Shuai
Shenzhen Traditional Chinese Medicine Hospital
Shenzhen
Jianyong Zhang
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Yuxuebi Tablet in Treating Night Pain of Ankylosing Spondylitis.
This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of Yuxuebi tablet in treating night pain of Ankylosing Spondylitis.
- Conditions
- Ankylosing Spondylitis
- Being tested
- Yuxuebi tablet, Placebo tablet
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yuxuebi tabletDrug
0.5g/ tablet
Placebo tabletDrug
0.5g/ tablet
| Study group | Role | What they receive |
|---|---|---|
| Yuxuebi tablet | Experimental | take 5 tablets once, 3 times a day, for 42（±3）days. Receives: Drug: Yuxuebi tablet |
| Placebo tablet | Placebo comparator | take 5 tablets once, 3 times a day, for 42（±3）days. Receives: Drug: Placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual analogue scale (VAS) for night pain
Measured: Baseline, at day 7, day 14, day 28, day 42 during treatment
Secondary outcomes (8)
Visual analogue scale (VAS) for whole day
Measured: Baseline, at day 7, day 14, day 28, day 42 during treatment
BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
Measured: Baseline, at day 28, day 42 during treatment
BASFI (Bath Ankylosing Spondylitis Functional Index)
Measured: Baseline, at day 28, day 42 during treatment
BASMI (Bath Ankylosing Spondylitis Metrology Index)
Measured: Baseline, at day 28, day 42 during treatment
Syndrome score of traditional Chinese medicine
The Evaluation Scale of Syndrome score ranges from 0 (best score) to 15 (worst score).
Measured: Baseline, at day 28, day 42 during treatment
SF-36 (The Medical Outcomes Study 36-item short-form health survey)
Measured: Baseline, at day 42 during treatment
ESR (Erythrocyte Sedimentation Rate)
Measured: Baseline, at day 14, day 28, day 42 during treatment
CRP (C-Reactive Protein)
Measured: Baseline, at day 14, day 28, day 42 during treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study start1 Jul 2021 (estimated)
- Primary completion31 Jan 2022 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing SpondylitisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04934059
- Sponsor's protocol ID
- 2020005P8A02
- Status last verified
- Jun 2021
- First submitted
- 8 Jun 2021
- Last updated
- 22 Jun 2021
- Results posted
- No
- 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 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Yuxuebi Tablet in Treating Night Pain of Ankylosing Spondylitis.
- ClinicalTrials.gov ID
- NCT04934059
- Acronym / sponsor ID
- 2020005P8A02
- Conditions
- Ankylosing Spondylitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- China Resources Sanjiu Medical & Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 22 Jun 2021 (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 is a multicenter, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of Yuxuebi tablet in treating night pain of Ankylosing Spondylitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yuxuebi tablet | Experimental | Drug: Yuxuebi tablettake 5 tablets once, 3 times a day, for 42（±3）days. |
| Placebo tablet | Placebo comparator | Drug: Placebo tablettake 5 tablets once, 3 times a day, for 42（±3）days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Ages 18-65, male or female
- Confirmed diagnosis of Ankylosing Spondylitis
- Syndrome of traditional Chinese medicine is blood stasis syndrome
- ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score)≥2.1
- Visual analogue scale (VAS) for night pain≥4分
Key exclusion criteria (15 listed)
- Pregnant or breastfeeding or who expecting to conceive
- Psoriatic arthritis or Enteropathic arthritis
- AS with iritis or uveitis
- Abnormal liver function
- Abnormal kidney function，high level of Creatinine
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 |
|---|---|---|
| Yuxuebi tablet0.5g/ tablet | Drug | Yuxuebi tablet |
| Placebo tablet0.5g/ tablet | Drug | Placebo tablet |
Primary outcome
Change in Visual analogue scale (VAS) for night pain
Time frame: Baseline, at day 7, day 14, day 28, day 42 during treatment
8 secondary outcomes
Visual analogue scale (VAS) for whole day
Time frame: Baseline, at day 7, day 14, day 28, day 42 during treatment
BASDAI (Bath Ankylosing Spondylitis Disease Activity Index)
Time frame: Baseline, at day 28, day 42 during treatment
BASFI (Bath Ankylosing Spondylitis Functional Index)
Time frame: Baseline, at day 28, day 42 during treatment
BASMI (Bath Ankylosing Spondylitis Metrology Index)
Time frame: Baseline, at day 28, day 42 during treatment
Syndrome score of traditional Chinese medicine
Time frame: Baseline, at day 28, day 42 during treatment
SF-36 (The Medical Outcomes Study 36-item short-form health survey)
Time frame: Baseline, at day 42 during treatment
ESR (Erythrocyte Sedimentation Rate)
Time frame: Baseline, at day 14, day 28, day 42 during treatment
CRP (C-Reactive Protein)
Time frame: Baseline, at day 14, day 28, day 42 during treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Yuxuebi tablet in people with Ankylosing Spondylitis, run by China Resources Sanjiu Medical & Pharmaceutical Co., Ltd. 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 10 inclusion and 15 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 22 Jun 2021. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Visual analogue scale (VAS) for night pain (time frame: Baseline, at day 7, day 14, day 28, day 42 during treatment). 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 22 Jun 2021.