Ankylosing SpondylitisPhase 2/3NCT04480359
Bawei Shenqi Pill in the Treatment of Ankylosing Spondylitis
A Phase 2/3 study testing Bawei Shenqi Pill and Meloxicam in people with Ankylosing Spondylitis, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
Trial summary
The purpose of this study is to determine whether Bawei Shenqi Pill is effective in the treatment of active ankylosing spondylitis (AS). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- Bawei Shenqi Pill and Meloxicam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2017to 30 Sep 2020
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Compliance with New York standards revised in 1984
- Syndrome differentiation of traditional Chinese medicine for deficiency of kidney-yang
- 18 to 70 years of age, male and female
- Being able to understand or sign an informed consent form
Who cannot join
- Other spondyloarthropathy that does not meet the diagnostic criteria of ankylosing spondylitis, and TCM syndrome differentiation does not belong to kidney-yang deficiency type.
- Age is out of range
- Do not agree to participate in this topic or can not participate in the whole process
- Complicated with other rheumatic diseases or other seronegative spondyloarthropathy.
- Pregnant, lactating women and patients with serious visceral diseases, mental disorders and severe extraarticular manifestations, such as heart, lung, liver, kidney or hematopoietic system.
- Have had myocardial infarction or stroke, congestive heart failure and active digestive tract ulcer patients.
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- Those who had received other research drugs three months before screening.
- Inability or unwillingness to provide informed consent or failure to comply with test requirements.
- The researchers believe that it is not suitable for the owners of the study.
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 Clinical Research of the Traditional Chinese Medicine Bawei Shenqi Pill in the Treatment of the Kidney Yang Deficiency Type of Ankylosing Spondylitis
The purpose of this study is to determine whether Bawei Shenqi Pill is effective in the treatment of active ankylosing spondylitis (AS).
Read the detailed description
Ankylosing spondylitis is a chronic inflammatory disease, which mainly invades sacroiliac joint, spinal osteoid process, paraspinal soft tissue and peripheral joints, and can be accompanied by extraarticular manifestations, in severe cases, spinal deformity and ankylosis can occur. The overall prevalence rate of ankylosing spondylitis in China is about 0.3%, the peak of which is 20 to 30 years old. although the prevalence rate is not high, the disability rate is high, and the patients with ankylosing spondylitis are mainly young people of childbearing age, which are in a critical period of work and study. If the disease can not be controlled smoothly, it will seriously affect its learning and work efficiency, image appearance and even the ability of daily life.
Bawei Shenqi Pill originates from Zhang Zhongjing's synopsis of the Golden Chamber, is the representative prescription of warming and tonifying kidney yang, and is also suitable for the pathogenesis of ankylosing spondylitis "deficiency of kidney yang". The purpose of this study was to observe the therapeutic effect of Bawei Shenqi Pill on ankylosing spondylitis of kidney-yang deficiency type through a randomized controlled clinical study. To clarify the effect of Bawei Shenqi Pill on disease activity, joint function, TCM syndrome integral and quality of life in patients with ankylosing spondylitis, and to provide basis for the treatment of ankylosing spondylitis with Bawei Shenqi Pill.
- Conditions
- Ankylosing Spondylitis
- Being tested
- Bawei Shenqi Pill, Bawei Shenqi Pill placebo, Meloxicam
- Keywords
- Bawei Shenqi Pill, ankylosing spondylitis, clinical research
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bawei Shenqi PillDrug
Also called Experimental:Bawei Shenqi group
5.1g, once a day, 3month, oral
Bawei Shenqi Pill placeboDrug
Also called Placebo Comparator: placebo group
5.1g, once a day, 3month, oral
MeloxicamDrug
Also called Experimental:Bawei Shenqi group, Placebo Comparator: placebo group
7.5mg, once a day, 3 month, oral
| Study group | Role | What they receive |
|---|---|---|
| Bawei Shenqi group | Active comparator | participants should administrate both Bawei Shenqi Pill and Meloxicam tablets Receives: Drug: Bawei Shenqi Pill; Drug: Meloxicam |
| placebo group | Placebo comparator | participants should administrate both Bawei Shenqi Pill placebo and Meloxicam tablets Receives: Drug: Bawei Shenqi Pill placebo; Drug: Meloxicam |
What is being measured
The primary outcome is the main question the study is designed to answer.
BASDAI
Bath Ankylosing Spondylitis Disease Activity Index
Measured: 12weeks
BASFI
Bath Ankylosing Spondylitis Functional Index
Measured: 12weeks
CRP
C-reactive protein
Measured: 12weeks
ESR
Erythrocyte sedimentation rate
Measured: 12weeks
Range of motion
occipital wall distance, chest expansion distance, finger ground distance, Schober test
Measured: 12weeks
Secondary outcomes (1)
SF-36
SF- 36 scale for quality of life assessment
Measured: at baseline and at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start1 Oct 2017
- Primary completion30 Aug 2020 (estimated)
- Study completion30 Sep 2020 (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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, maojianchun, Shanghai University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04480359
- Sponsor's protocol ID
- Bawei Shenqi Pill
- Status last verified
- Jul 2020
- First submitted
- 16 Jul 2020
- Last updated
- 14 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Research of the Traditional Chinese Medicine Bawei Shenqi Pill in the Treatment of the Kidney Yang Deficiency Type of Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT04480359
- Acronym / sponsor ID
- Bawei Shenqi Pill
- Conditions
- Ankylosing Spondylitis
- Keywords
- Bawei Shenqi Pill, ankylosing spondylitis, clinical research
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 30 Aug 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 21 Jul 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.
The purpose of this study is to determine whether Bawei Shenqi Pill is effective in the treatment of active ankylosing spondylitis (AS).
Detailed description
Ankylosing spondylitis is a chronic inflammatory disease, which mainly invades sacroiliac joint, spinal osteoid process, paraspinal soft tissue and peripheral joints, and can be accompanied by extraarticular manifestations, in severe cases, spinal deformity and ankylosis can occur. The overall prevalence rate of ankylosing spondylitis in China is about 0.3%, the peak of which is 20 to 30 years old. although the prevalence rate is not high, the disability rate is high, and the patients with ankylosing spondylitis are mainly young people of childbearing age, which are in a critical period of work and study. If the disease can not be controlled smoothly, it will seriously affect its learning and work efficiency, image appearance and even the ability of daily life.
Bawei Shenqi Pill originates from Zhang Zhongjing's synopsis of the Golden Chamber, is the representative prescription of warming and tonifying kidney yang, and is also suitable for the pathogenesis of ankylosing spondylitis "deficiency of kidney yang". The purpose of this study was to observe the therapeutic effect of Bawei Shenqi Pill on ankylosing spondylitis of kidney-yang deficiency type through a randomized controlled clinical study. To clarify the effect of Bawei Shenqi Pill on disease activity, joint function, TCM syndrome integral and quality of life in patients with ankylosing spondylitis, and to provide basis for the treatment of ankylosing spondylitis with Bawei Shenqi Pill.
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 |
|---|---|---|
| Bawei Shenqi group | Active comparator | Drug: Bawei Shenqi Pill, Drug: Meloxicamparticipants should administrate both Bawei Shenqi Pill and Meloxicam tablets |
| placebo group | Placebo comparator | Drug: Bawei Shenqi Pill placebo, Drug: Meloxicamparticipants should administrate both Bawei Shenqi Pill placebo and Meloxicam tablets |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Compliance with New York standards revised in 1984
- Syndrome differentiation of traditional Chinese medicine for deficiency of kidney-yang
- 18 to 70 years of age, male and female
- Being able to understand or sign an informed consent form
Key exclusion criteria (9 listed)
- Other spondyloarthropathy that does not meet the diagnostic criteria of ankylosing spondylitis, and TCM syndrome differentiation does not belong to kidney-yang deficiency type.
- Age is out of range
- Do not agree to participate in this topic or can not participate in the whole process
- Complicated with other rheumatic diseases or other seronegative spondyloarthropathy.
- Pregnant, lactating women and patients with serious visceral diseases, mental disorders and severe extraarticular manifestations, such as heart, lung, liver, kidney or hematopoietic system.
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 |
|---|---|---|
| Bawei Shenqi PillAlso: Experimental:Bawei Shenqi group5.1g, once a day, 3month, oral | Drug | Bawei Shenqi group |
| Bawei Shenqi Pill placeboAlso: Placebo Comparator: placebo group5.1g, once a day, 3month, oral | Drug | placebo group |
| MeloxicamAlso: Experimental:Bawei Shenqi group, Placebo Comparator: placebo group7.5mg, once a day, 3 month, oral | Drug | Bawei Shenqi group, placebo group |
Primary outcome
BASDAI
Time frame: 12weeks
Bath Ankylosing Spondylitis Disease Activity Index
BASFI
Time frame: 12weeks
Bath Ankylosing Spondylitis Functional Index
CRP
Time frame: 12weeks
C-reactive protein
ESR
Time frame: 12weeks
Erythrocyte sedimentation rate
Range of motion
Time frame: 12weeks
occipital wall distance, chest expansion distance, finger ground distance, Schober test
1 secondary outcome
SF-36
Time frame: at baseline and at 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
- 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.
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 Bawei Shenqi Pill and Meloxicam in people with Ankylosing Spondylitis, 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 9 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 14 Aug 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 (86-18917763231, mjcct2018@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BASDAI (time frame: 12weeks). The study lists 5 primary outcomes in all. 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 14 Aug 2020.