SpondyloarthritisPhase 2NCT03932019
Study of Jitongning Tablet to Treat Spondyloarthritis
A Phase 2 study testing Jitongning tablet(High-dose ) and Jitongning tablet(Low-dose ) in people with Spondyloarthritis, run by Tasly Pharmaceutical Group Co., Ltd at 11 sites in China.
Trial summary
This study is to investigate the efficacy and safety of Jitongning Tablet in improving joint function and pain symptoms in active axial spondyloarthritis (SpA) patients and to explore the optimal dosage. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spondyloarthritis
- What is being tested?
- Jitongning tablet(High-dose ) and Jitongning tablet(Low-dose )
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 238 participants
- Where
- 11 sitesChina
- Study dates
- 11 Jun 2019to 20 Aug 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
- Men or women aged 18 to 65 years old (including 18 and 65) ;
- Meeting the diagnostic criteria for active axial SpA according to the the ASAS classification 2009, defined as satisfied 2 of the following:
- BASDAI score ≥ 4;
- In the assessment of pain numerical rating scale (NRS), spine pain NRS ≥ 4;
- Meeting the standard of TCM syndrome diagnosis for kidney yang deficiency and biood stasis stagnating syndrome;
- Sacroiliac arthritis of CT categories I(A)~Ⅲ(B) (including I(A) and Ⅲ(B));
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- Human leukocyte antigen B27 (HLA-B27) is positive;
- C-reactive protein (CRP)/hypersensitive C-reactive protein (hsCRP) and/or erythrocyte sedimentation rate raised;
- Voluntary signing of informed consent.
Who cannot join
- Those who use NSAIDs in the first 2 weeks of randomization;
- In the first 4 weeks of randomization, take disease-modifying antirheumatic Chinese herbal medicine or Chemical drugs (such as sulfasalazine ,methotrexate, leflunomide, Chloroquine, Total glycosides of Tripterygium, Cyclophosphamide, Azathioprine, etc),opioid analgesics(Methadone, Morphine, etc.) ,systemic glucocorticoid therapy;
- In the first 3 months of randomization, take biological agents that have been used for spinal arthritis;
- Those who have undergone spinal surgery or joint surgery within 8 weeks before randomization;
- Patients who received intra-articular injection, spinal or paravertebral injection of corticosteroids within the first 6 months of randomization;
- The spine is completely stiff (fused);
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- Any Other rheumatic immune system diseases or immunodeficiency syndromes such as ulcerative colitis, psoriasis, uveitis, etc.
- Those who have a fertility requirement within 6 months;
- Women during pregnancy and lactation;
- Suspected or indeed drug use, substance abuse, alcoholism;
- In the first 3 months of randomization, take the test or in progress;
- Serious cardiovascular, Liver , kidney, brain, mental, neurological disorders that affect informed consent and/or adverse event expression or observation;
- Abnormal liver function(the AST or ALT value is above the upper limit of the normal); Abnormal renal function (serum creatinine is above the upper limit of normal);
- Due to other circumstances, the investigator considered it inappropriate for the participants.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
China11 sites
The First Affiliated Hospital of hunan Medical University
Changsha, Hunan
The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine
Guangzhou, Guangdong
The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
Hefei, Anhui
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan
Yunnan Province Hospital of Traditional Chinese Medicine
Kunming, Yunnan
Jiangsu Province Hospital of Integrated Traditional Chinese and Western Medicine
Nanjing, Jiangsu
Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
About this study
Official title: A Randomized, Double-blind, Placebo-controled, Multi-center Phase II Clinical Trial for Evaluation of the Efficacy and Safety of Jitongning Tablet in Patients With Active Axial Spondyloarthritis(SpA)
This study is to investigate the efficacy and safety of Jitongning Tablet in improving joint function and pain symptoms in active axial spondyloarthritis (SpA) patients and to explore the optimal dosage.
Read the detailed description
Jitongning Tablet is a kind of traditional Chinese medicine(TCM), consists of Cortex Eucommiae, Duhuo(Radix Angelicae Pubescentis), Zhichuanwu(Radix Aconiti) , Rhizoma Corydalis, Radix Paeoniae Rubra, Radix Puerariae and Radix Glycyrrhizae. This study is being conducted to evaluate the efficacy and safety of Jitongning Tablet in patients with active axial spondyloarthritis (SpA) (Syndrome Of Kidney Yang Deficiency and Biood Stasis Stagnation), when compared with placebo and to explore the optimal dosage.
- Conditions
- Spondyloarthritis
- Being tested
- Jitongning tablet(High-dose ), Jitongning tablet(Low-dose ), Placebo
- Keywords
- Jitongning Tablet, Spondyloarthritis
- Medical subject headings
- Spondylarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Jitongning tablet(High-dose )Drug
Also called Jitongning tablet,3tablets
Jitongning tablet,3tablets,bid,treat 12 weeks
Jitongning tablet(Low-dose )Drug
Also called Jitongning tablet,2tablets,Jitongning tablet placebo,1tablet,
Jitongning tablet,2tablets,bid,treat 12 weeks Jitongning tablet placebo,1tablet,bid,treat 12 weeks
PlaceboDrug
Also called Jitongning tablet placebo,3tablets
Jitongning tablet placebo,3tablets,bid,treat 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Jitongning tablet High dose group | Experimental | Jitongning tablet,3tablets,bid,po Receives: Drug: Jitongning tablet(High-dose ) |
| Jitongning tablet Low dose group | Experimental | Jitongning tablet,2tablets,bid,po Jitongning tablet placebo,1tablet,bid,po Receives: Drug: Jitongning tablet(Low-dose ) |
| Placebo Comparator controlled group | Placebo comparator | Placebo Comparator: Jitongning tablet placebo,3tablets,bid,po Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ASAS 20 response
The percentage of subjects who achieved ASAS 20 response at 12th weeks
Measured: 12 weeks
Secondary outcomes (7)
BASDAI
the score changes of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at each visit compared to baseline.
This instrument consists of six 10cm horizontal visual analog scales to measure severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness (both qualitative and quantitative). The final BASDAI score has a range of 0 to 10. The mean of which gives the BASDAI score (0-10). The severity of patient's symptoms from 0 (none) to 10 (most severe).
Measured: 4 weeks,8weeks,12weeks
BASFI
the score changes of Bath Ankylosing Spondylitis Functional Index (BASFI) at each visit compared to baseline.
This instrument consists of 8 specific questions regarding function in AS and 2 questions reflecting the patient's ability to cope with everyday life. Each question is answered on a 10 cm horizontal visual analog scale, the mean of which gives the BASFI score (0-10). The severity of patient's symptoms from 0 (none) to 10 (most severe).
Measured: 4 weeks,8weeks,12weeks
Spinal pain
the score changes of Spinal pain at each visit compared to baseline. Spinal pain was scored as the average of two VAS questions about total spinal pain and nocturnal spinal pain. The mean of which gives the spinal pain score (0-10). The severity of patient's symptoms from 0 (none) to 10 (most severe).
Measured: 4 weeks,8weeks,12weeks
PGA
the score changes of PGA at each visit compared to baseline. Patient global assessment was measured using a set of visual analogue scales (VAS) on which patients rated the severity of their disease from 0 (none) to 10 (most severe).
Measured: 4 weeks,8weeks,12weeks
TCM syndrome scores
the score changes of TCM syndrome scores at each visit compared to baseline. This instrument consists of three primary symptoms: spinal pain, spinal function limited, morning stiffness and six secondary symptoms: nocturnal back pain、stabbing pain、Local cold pain、aversion to cold,preference for heat、heel pain、weakness in the lower back and knees. Four levels to measure severity of primary symptoms（0、2、4、6）and secondary symptoms（0、1、2、3）, respectively. Record the tongue and pulse conditions. The final score has a range of 0 to 100. The severity of patient's symptoms from 0 (none) to 100(most severe).The TCM syndrome effect calculated by nimodipine method. The effect of TCM syndrome from negative (worsen) to 100% (disappear).
Measured: 4 weeks,8weeks,12weeks
CRP/hsCRP and ESR
the changes of CRP/hsCRP and ESR at each visit compared to baseline
Measured: 4 weeks,8weeks,12weeks
Exposure of ibuprofen sustained release capsules
Exposure of ibuprofen sustained release capsules in test group and placebo at 12th weeks.
Exposure of ibuprofen sustained release capsules refers to the quantity of ibuprofen capsules patient actually took. The difference between the total dispensed quantity and the sum of recycling quantity and missing quantity gives the exposure of ibuprofen sustained release capsules. The exposure of ibuprofen sustained release capsules from 0 (none) to 372 (maximum).
Measured: 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start11 Jun 2019
- Primary completion20 Jun 2021
- Study completion20 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by Tasly Pharmaceutical Group Co., LtdThe sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tasly Pharmaceutical Group Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rui Liu, Study director, Tasly Group, Co. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03932019
- Sponsor's protocol ID
- TSL-TCM-JTNP-01
- Status last verified
- Nov 2022
- First submitted
- 26 Apr 2019
- Last updated
- 21 Nov 2022
- 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 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controled, Multi-center Phase II Clinical Trial for Evaluation of the Efficacy and Safety of Jitongning Tablet in Patients With Active Axial Spondyloarthritis(SpA)
- ClinicalTrials.gov ID
- NCT03932019
- Acronym / sponsor ID
- TSL-TCM-JTNP-01
- Conditions
- Spondyloarthritis
- Keywords
- Jitongning Tablet, Spondyloarthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Tasly Pharmaceutical Group Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 11 Jun 2019 (actual)
- Primary completion
- 20 Jun 2021 (actual)
- Study completion
- 20 Aug 2021 (actual)
- First posted
- 30 Apr 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.
This study is to investigate the efficacy and safety of Jitongning Tablet in improving joint function and pain symptoms in active axial spondyloarthritis (SpA) patients and to explore the optimal dosage.
Detailed description
Jitongning Tablet is a kind of traditional Chinese medicine(TCM), consists of Cortex Eucommiae, Duhuo(Radix Angelicae Pubescentis), Zhichuanwu(Radix Aconiti) , Rhizoma Corydalis, Radix Paeoniae Rubra, Radix Puerariae and Radix Glycyrrhizae. This study is being conducted to evaluate the efficacy and safety of Jitongning Tablet in patients with active axial spondyloarthritis (SpA) (Syndrome Of Kidney Yang Deficiency and Biood Stasis Stagnation), when compared with placebo and to explore the optimal dosage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Jitongning tablet High dose group | Experimental | Drug: Jitongning tablet(High-dose )Jitongning tablet,3tablets,bid,po |
| Jitongning tablet Low dose group | Experimental | Drug: Jitongning tablet(Low-dose )Jitongning tablet,2tablets,bid,po Jitongning tablet placebo,1tablet,bid,po |
| Placebo Comparator controlled group | Placebo comparator | Drug: PlaceboPlacebo Comparator: Jitongning tablet placebo,3tablets,bid,po |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men or women aged 18 to 65 years old (including 18 and 65) ;
- Meeting the diagnostic criteria for active axial SpA according to the the ASAS classification 2009, defined as satisfied 2 of the following:
- Meeting the standard of TCM syndrome diagnosis for kidney yang deficiency and biood stasis stagnating syndrome;
- Sacroiliac arthritis of CT categories I(A)~Ⅲ(B) (including I(A) and Ⅲ(B));
- Human leukocyte antigen B27 (HLA-B27) is positive;
Key exclusion criteria (14 listed)
- Those who use NSAIDs in the first 2 weeks of randomization;
- In the first 4 weeks of randomization, take disease-modifying antirheumatic Chinese herbal medicine or Chemical drugs (such as sulfasalazine ,methotrexate, leflunomide, Chloroquine, Total glycosides of Tripterygium, Cyclophosphamide, Azathioprine, etc),opioid analgesics(Methadone, Morphine, etc.) ,systemic glucocorticoid therapy;
- In the first 3 months of randomization, take biological agents that have been used for spinal arthritis;
- Those who have undergone spinal surgery or joint surgery within 8 weeks before randomization;
- Patients who received intra-articular injection, spinal or paravertebral injection of corticosteroids within the first 6 months of randomization;
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 |
|---|---|---|
| Jitongning tablet(High-dose )Also: Jitongning tablet,3tabletsJitongning tablet,3tablets,bid,treat 12 weeks | Drug | Jitongning tablet High dose group |
| Jitongning tablet(Low-dose )Also: Jitongning tablet,2tablets,Jitongning tablet placebo,1tablet,Jitongning tablet,2tablets,bid,treat 12 weeks Jitongning tablet placebo,1tablet,bid,treat 12 weeks | Drug | Jitongning tablet Low dose group |
| PlaceboAlso: Jitongning tablet placebo,3tabletsJitongning tablet placebo,3tablets,bid,treat 12 weeks | Drug | Placebo Comparator controlled group |
Primary outcome
ASAS 20 response
Time frame: 12 weeks
The percentage of subjects who achieved ASAS 20 response at 12th weeks
7 secondary outcomes
BASDAI
Time frame: 4 weeks,8weeks,12weeks
BASFI
Time frame: 4 weeks,8weeks,12weeks
Spinal pain
Time frame: 4 weeks,8weeks,12weeks
PGA
Time frame: 4 weeks,8weeks,12weeks
TCM syndrome scores
Time frame: 4 weeks,8weeks,12weeks
CRP/hsCRP and ESR
Time frame: 4 weeks,8weeks,12weeks
Exposure of ibuprofen sustained release capsules
Time frame: 12weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- 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.
Rui Liu study director
Tasly Group, Co. Ltd.
11 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 Jitongning tablet(High-dose ) and Jitongning tablet(Low-dose ) in people with Spondyloarthritis, run by Tasly Pharmaceutical Group Co., Ltd at 11 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 9 inclusion and 14 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: finished, as of the sponsor's last update on 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ASAS 20 response (time frame: 12 weeks). 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 21 Nov 2022.