Rheumatoid ArthritisNCT06309030
Clinical Study on the Deep Remission of Rheumatoid Arthritis With Kidney Deficiency and Excessive Cold Syndrome by Bushen Quhan Zhiwang Decoction
A study testing Bushen quhan zhiwang decoction in people with Rheumatoid Arthritis, run by Liu Longxiao.
Trial summary
The investigators conduct this randomized controlled clinical trial to evaluate the efficacy and safety of the Bushen Quhan Zhiwang decoction in patients with RA with kidney deficiency and excessive cold syndrome who have not achieved deep remission and remained at a low level of disease activity despite the use of… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Bushen quhan zhiwang decoction
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 1 Aug 2026
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients meeting the ACR/European League against Rheumatism (EULAR) 2010 classification criteria；
- Patients meeting the diagnostic crite ria (2018 edition) for "kidney deficiency and excessive cold syndrome" in Chinese medicine；
- The disease activity score derivative for 28 joints (DAS28) score should be 2.6 to 3.2；
- Use of traditional disease-modifying antirheumatic drugs (DMARDs), tretinoin preparations, etc., limited to 1 type and have been treated at a stable dose for at least 4 weeks prior to enrollment, and the dose of the medication remains unchanged after enrollment；
- For those taking oral glucocorticosteroids prior to enrollment, the dose must be stabilized to a dose equivalent to ≤10 mg/day of prednisone for at least 4 weeks prior to enrollment and remain unchanged after enrollment；
- Those using non-steroidal anti-inflammatory drugs (NSAIDs) or other analgesics for RA must have been on a stable dose for at least 1 week prior to enrollment and the dose of medication must remain unchanged after enrollment；
- Voluntary participation and written informed consent.
Who cannot join
- Previously treated with small molecule targeted drugs or biologics and discontinued for <4 weeks；
- Those who have been treated with intra-articular, intramuscular or intravenous corticosteroids, including pro-adrenal hormones, within 4 weeks prior to enrollment；
- Those with a combination of clearly diagnosed autoimmune diseases such as systemic lupus erythematosus, scleroderma, Sjogrensyndrome, etc.；
- Organ transplant recipients, patients with malignant tumors, patients with heart, brain, liver (ALT/AST>3 times the upper limit of normal), kidney (Ccr<60ml/min) and other important organ function damage or blood system diseases；
- With psychosomatic disorders such as cognitive impairment, depression, anxiety, and somatic dysfunction, central nervous disorders such as cerebral infarction, cerebral hemorrhage, epilepsy, TIA, myelitis, demyelinating lesions, or peripheral neurological disorders such as restless leg syndrome；
- Women and men who are pregnant or breastfeeding or who plan to become pregnant in the next 6 months; women of childbearing age who are unable or unwilling to use adequate contraception or whose partners are unwilling to use contraception, either during the trial period or within 1 month after the last dose of medication；
- BMI greater than 35 (kg/m2), allergic to the test drug, or participating in other clinical trials；
- Other conditions deemed by the investigator to make participation in the trial unsuitable (out-of-town patients unable to follow up, etc.).
About this study
The investigators conduct this randomized controlled clinical trial to evaluate the efficacy and safety of the Bushen Quhan Zhiwang decoction in patients with RA with kidney deficiency and excessive cold syndrome who have not achieved deep remission and remained at a low level of disease activity despite the use of conventional synthetic disease-modifying antirheumatic drugs.
Read the detailed description
In this study, a randomized, double-blind, placebo-controlled clinical research methodology was proposed using computerized SPSS software to randomize the group to include 72 cases of RA patients who had been treated regularly with traditional RA disease-improving antirheumatic drugs for more than 3 months and whose disease was still at a low level of disease activity. On the basis of RA traditional condition-improving antirheumatic drug treatment, the treatment group was given Inib soup to tonify the kidney, dispel cold and cure the inibs, and the control group was given an analog of Inib soup to tonify the kidney, dispel cold and cure the inibs, with a 12-week treatment period and a 4-week follow-up period, in order to observe the efficacy and safety of the inibs based on the tonifying the kidney, dispel cold and cure the inibs on the clinical depth of relief of RA pain, and to assess the DAS-28, the VAS score of pain, the mechanical pain threshold, and laboratory laboratory laboratory tests (blood and urine routine, liver and renal function, ESR, CRP, RF, ACPA), electrocardiogram, compare the differences between the two groups in each of the above indexes and conduct correlation analysis, so as to provide evidence-based medical evidence for clinical practice. Based on clinical practice, explore the effect of tonifying the kidney, dispelling cold and curing Inibs to improve the clinical remission of RA, and provide a new strategy for the standardized treatment and clinical remission of RA. Using a combination of pain VAS scores and objective mechanical pain threshold measurements, we evaluated the effect of tonifying the kidneys, dispelling cold, and curing inibs on the pain relief of RA patients with kidney deficiency and cold-sheng syndrome, and provided references for the relief of RA pain.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Bushen quhan zhiwang decoction, Bushen quhan zhiwang decoction placebo
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bushen quhan zhiwang decoctionDrug
Treatment with 100ml of Bushen quhan zhiwang decoction twice a day for 3 months.
Bushen quhan zhiwang decoction placeboDrug
Treatment with 100ml of Bushen quhan zhiwang decoction placebo twice a day for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Drug: Bushen quhan zhiwang decoction |
| Control group | Placebo comparator | Not described Receives: Drug: Bushen quhan zhiwang decoction placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease activity score derivative for 28 joints (DAS28)
DAS28 (CRP) = 0.56*√(TJC28) +0.28*√(SJC28)+0.014*GH+0.36*ln(CRP+1)+0.96; DAS28 (ESR) = 0.56*√(TJC28)+0.28*√(SJC28)+0.014*GH+0.70*ln(ESR), where TJC = tender joint count and SJC = swollen joint count.
Measured: Enrolment, 4 weeks, 8 weeks,12 weeks and 16 weeks after intervention.
Secondary outcomes (6)
patient reported outcomes（PRO）
assessed by a dedicated rheumatologist (associate senior physician or better)
Measured: Enrolment, 4 weeks, 8 weeks,12 weeks and 16 weeks after intervention.
visual analogue scale for pain
assessed by a dedicated rheumatologist (associate senior physician or better)
Measured: Enrolment, 4 weeks, 8 weeks,12 weeks and 16 weeks after intervention.
withdrawl mechanical threshold
Von Frey test：The value of the minimum force that causes the patient to feel "pain" is the patient's mechanical pain threshold.
Measured: Enrolment, 4 weeks, 8 weeks,12 weeks and 16 weeks after intervention.
erythrocyte sedimentation Rate（ESR）
Measured by the Laboratory of China-Japan Friendship Hospital
Measured: Enrolment, 4 weeks,12 weeks after intervention.
C-reactive protein（CRP）
Measured by the Laboratory of China-Japan Friendship Hospital
Measured: Enrolment, 4 weeks,12 weeks after intervention.
TCM symptom score
assessed by a dedicated rheumatologist (associate senior physician or better)
Measured: Enrolment, 4 weeks, 8 weeks,12 weeks and 16 weeks after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liu Longxiao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liu Longxiao, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06309030
- Sponsor's protocol ID
- ZRJY2023-QM21
- Status last verified
- Mar 2024
- First submitted
- 7 Mar 2024
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Deep Remission of Rheumatoid Arthritis With Kidney Deficiency and Excessive Cold Syndrome by Bushen Quhan Zhiwang Decoction
- ClinicalTrials.gov ID
- NCT06309030
- Acronym / sponsor ID
- ZRJY2023-QM21
- Conditions
- Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Liu LongxiaoUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 13 Mar 2024 (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 investigators conduct this randomized controlled clinical trial to evaluate the efficacy and safety of the Bushen Quhan Zhiwang decoction in patients with RA with kidney deficiency and excessive cold syndrome who have not achieved deep remission and remained at a low level of disease activity despite the use of conventional synthetic disease-modifying antirheumatic drugs.
Detailed description
In this study, a randomized, double-blind, placebo-controlled clinical research methodology was proposed using computerized SPSS software to randomize the group to include 72 cases of RA patients who had been treated regularly with traditional RA disease-improving antirheumatic drugs for more than 3 months and whose disease was still at a low level of disease activity. On the basis of RA traditional condition-improving antirheumatic drug treatment, the treatment group was given Inib soup to tonify the kidney, dispel cold and cure the inibs, and the control group was given an analog of Inib soup to tonify the kidney, dispel cold and cure the inibs, with a 12-week treatment period and a 4-week follow-up period, in order to observe the efficacy and safety of the inibs based on the tonifying the kidney, dispel cold and cure the inibs on the clinical depth of relief of RA pain, and to assess the DAS-28, the VAS score of pain, the mechanical pain threshold, and laboratory laboratory laboratory tests (blood and urine routine, liver and renal function, ESR, CRP, RF, ACPA), electrocardiogram, compare the differences between the two groups in each of the above indexes and conduct correlation analysis, so as to provide evidence-based medical evidence for clinical practice. Based on clinical practice, explore the effect of tonifying the kidney, dispelling cold and curing Inibs to improve the clinical remission of RA, and provide a new strategy for the standardized treatment and clinical remission of RA. Using a combination of pain VAS scores and objective mechanical pain threshold measurements, we evaluated the effect of tonifying the kidneys, dispelling cold, and curing inibs on the pain relief of RA patients with kidney deficiency and cold-sheng syndrome, and provided references for the relief of RA pain.
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 |
|---|---|---|
| Intervention group | Experimental | Drug: Bushen quhan zhiwang decoction |
| Control group | Placebo comparator | Drug: Bushen quhan zhiwang decoction placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients meeting the ACR/European League against Rheumatism (EULAR) 2010 classification criteria；
- Patients meeting the diagnostic crite ria (2018 edition) for "kidney deficiency and excessive cold syndrome" in Chinese medicine；
- The disease activity score derivative for 28 joints (DAS28) score should be 2.6 to 3.2；
- Use of traditional disease-modifying antirheumatic drugs (DMARDs), tretinoin preparations, etc., limited to 1 type and have been treated at a stable dose for at least 4 weeks prior to enrollment, and the dose of the medication remains unchanged after enrollment；
- For those taking oral glucocorticosteroids prior to enrollment, the dose must be stabilized to a dose equivalent to ≤10 mg/day of prednisone for at least 4 weeks prior to enrollment and remain unchanged after enrollment；
Key exclusion criteria (8 listed)
- Previously treated with small molecule targeted drugs or biologics and discontinued for <4 weeks；
- Those who have been treated with intra-articular, intramuscular or intravenous corticosteroids, including pro-adrenal hormones, within 4 weeks prior to enrollment；
- Those with a combination of clearly diagnosed autoimmune diseases such as systemic lupus erythematosus, scleroderma, Sjogrensyndrome, etc.；
- Organ transplant recipients, patients with malignant tumors, patients with heart, brain, liver (ALT/AST>3 times the upper limit of normal), kidney (Ccr<60ml/min) and other important organ function damage or blood system diseases；
- With psychosomatic disorders such as cognitive impairment, depression, anxiety, and somatic dysfunction, central nervous disorders such as cerebral infarction, cerebral hemorrhage, epilepsy, TIA, myelitis, demyelinating lesions, or peripheral neurological disorders such as restless leg syndrome；
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 |
|---|---|---|
| Bushen quhan zhiwang decoctionTreatment with 100ml of Bushen quhan zhiwang decoction twice a day for 3 months. | Drug | Intervention group |
| Bushen quhan zhiwang decoction placeboTreatment with 100ml of Bushen quhan zhiwang decoction placebo twice a day for 3 months. | Drug | Control group |
Primary outcome
disease activity score derivative for 28 joints (DAS28)
Time frame: Enrolment, 4 weeks, 8 weeks,12 weeks and 16 weeks after intervention.
DAS28 (CRP) = 0.56*√(TJC28) +0.28*√(SJC28)+0.014*GH+0.36*ln(CRP+1)+0.96; DAS28 (ESR) = 0.56*√(TJC28)+0.28*√(SJC28)+0.014*GH+0.70*ln(ESR), where TJC = tender joint count and SJC = swollen joint count.
6 secondary outcomes
patient reported outcomes（PRO）
Time frame: Enrolment, 4 weeks, 8 weeks,12 weeks and 16 weeks after intervention.
visual analogue scale for pain
Time frame: Enrolment, 4 weeks, 8 weeks,12 weeks and 16 weeks after intervention.
withdrawl mechanical threshold
Time frame: Enrolment, 4 weeks, 8 weeks,12 weeks and 16 weeks after intervention.
erythrocyte sedimentation Rate（ESR）
Time frame: Enrolment, 4 weeks,12 weeks after intervention.
C-reactive protein（CRP）
Time frame: Enrolment, 4 weeks,12 weeks after intervention.
TCM symptom score
Time frame: Enrolment, 4 weeks, 8 weeks,12 weeks and 16 weeks after intervention.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Bushen quhan zhiwang decoction in people with Rheumatoid Arthritis, run by Liu Longxiao.
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 7 inclusion and 8 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 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
disease activity score derivative for 28 joints (DAS28) (time frame: Enrolment, 4 weeks, 8 weeks,12 weeks and 16 weeks after intervention.). 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 13 Mar 2024.