Arthritis, RheumatoidEarly Phase 1NCT05508815
Modified Zhiwang Decoction Combined With Methotrexate in the Treatment of Early Rheumatoid Arthritis
A Early Phase 1 study testing Modified Zhiwang Decoction Combined with methotrexate and Methotrexate in people with Arthritis, Rheumatoid, run by Beijing University of Chinese Medicine at 1 site in China.
Trial summary
The aim of this study is to evaluate the effectiveness and safety of Modified Zhiwang Decoction in combination with methotrexate for the treatment of early RA patients and a parallel-group, single-center randomized controlled clinical study was designed. Read more about this study
- Who is it for?
- Ages 16 to 70 years
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- Modified Zhiwang Decoction Combined with methotrexate and Methotrexate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 9 Feb 2023to 31 Dec 2024
- Phase
- Early Phase 1
- 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 16 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients aged 16-70 years old;
- Patients who meet the diagnostic criteria of 2010 ACR/EULAR .
- Patients who meet the diagnostic criteria of cold pattern.
- Disease activity score(DAS28) ≤5.2.
Who cannot join
- Patients accompanied with other rheumatic diseases or severe pain due to other medical conditions, such as diabetic pain or post-herpetic neuralgia;
- Patients with joint dysfunction and the X-ray score of wrists is grade IV;
- Patients accompanied with mental and psychological disorders such as cognitive impairment, depression, anxiety, physical dysfunction, cerebral infarction, cerebral hemorrhage, epilepsy, TIA, myelitis, demyelinating disease and other central nervous system diseases.
- Patients accompanied with organ injury or malignant tumors, disorders of the cardiovascular system, liver(ALT/AST>3 times higher than the upper limit of normal), kidneys(Ccr<60ml/min), brain, or hematopoietic system.
- Pregnant and lactating women.
- Patients are participation in any other clinical trials.
- Patients who are allergic to the drugs used in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing
Liu-bo Zhang, +861084205067, 597810955@qq.com
About this study
Official title: The Efficacy and Safety of the Modified Zhiwang Decoction Combined With Methotrexate in Early Rheumatoid Arthritis
The aim of this study is to evaluate the effectiveness and safety of Modified Zhiwang Decoction in combination with methotrexate for the treatment of early RA patients and a parallel-group, single-center randomized controlled clinical study was designed.
Read the detailed description
Rheumatoid Arthritis(RA) is a progressive inflammatory autoimmune disease characterized by chronic systemic inflammation, which can cause swelling, stiffening and articular cartilage and bone destruction. Early diagnosis and treatment in RA can improve outcomes and slow progression of joint damage. Modified Zhiwang Decoction(MZWD) has great curative effects for treating RA. However, few randomized clinical trials(RCTs) have evaluated the effectiveness of MZWD for the treatment of early RA. Therefore, a parallel-group randomized controlled trial was designed to evaluate the efficacy and safety of MZWD combined with methotrexate on early RA.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- Modified Zhiwang Decoction Combined with methotrexate, Methotrexate
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Zhiwang Decoction Combined with methotrexateDrug
Modified Zhiwang Decoction 100 ml (twice, per day) and methotrexate (7.5-15mg, once a week) for 12 weeks.
MethotrexateDrug
Methotrexate(7.5-15mg, once a week) for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Modified Zhiwang Decoction Combined with Methotrexate | Experimental | Not described Receives: Drug: Modified Zhiwang Decoction Combined with methotrexate |
| Methotrexate | Active comparator | Not described Receives: Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
DAS28 based on erythrocyte sedimentation rate scores
DAS28 is widely accepted to evaluate RA disease activity and consists of number of tender joints out of 28, number of swollen joints out of 28, ESR and the patient's global assessment of disease activity.
Measured: 12 weeks
Secondary outcomes (5)
Fatigue scale-14
The fatigue scale-14 is a standardized questionnaire regarding physical and mental fatigue. The higher the score, the greater the fatigue.
Measured: 12 weeks
Visual analogue scale pain scores
Visual analogue scale pain score is utilized to quantify the pain level that ranges from 0 to 10. A VAS score of 0 means no pain and a score of 10 means unbear-able pain.
Measured: 12 weeks
Traditional chinese medicine symptom scores
Traditional chinese medicine symptom score is calculated based on the percentage of symptom score reduction(PSSR) and the formula is as follows:
PSSR=((symptom score before treatment-symptom score after treatemt)/(symptom score before treatment))×100%
Measured: 12 weeks
Erythrocyte sedimentation rate
Measured: 12 weeks
C-reactive protein
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start9 Feb 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthritis, RheumatoidStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zhang liubo, Beijing University of Chinese Medicine
- Investigators
- Yuan Xu, Study chair, China-Japan Friendship HospitalCheng Xiao, Study director, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05508815
- Sponsor's protocol ID
- zliubo
- Status last verified
- May 2023
- First submitted
- 15 Aug 2022
- Last updated
- 25 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang N, Zhang LB, Wang Z, Lan TY, Wang JP, Xiao C, Tao QW, Xu Y. Efficacy and safety of the modified Zhiwang decoction combined with methotrexate in early rheumatoid arthritis: study protocol for a randomised controlled trial. BMJ Open. 2024 Jan 18;14(1):e076571. doi: 10.1136/bmjopen-2023-076571.
PubMed 38238175
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of the Modified Zhiwang Decoction Combined With Methotrexate in Early Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT05508815
- Acronym / sponsor ID
- zliubo
- Conditions
- Arthritis, Rheumatoid
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Beijing University of Chinese MedicineUniversity, hospital or other
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 Aug 2022 (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 aim of this study is to evaluate the effectiveness and safety of Modified Zhiwang Decoction in combination with methotrexate for the treatment of early RA patients and a parallel-group, single-center randomized controlled clinical study was designed.
Detailed description
Rheumatoid Arthritis(RA) is a progressive inflammatory autoimmune disease characterized by chronic systemic inflammation, which can cause swelling, stiffening and articular cartilage and bone destruction. Early diagnosis and treatment in RA can improve outcomes and slow progression of joint damage. Modified Zhiwang Decoction(MZWD) has great curative effects for treating RA. However, few randomized clinical trials(RCTs) have evaluated the effectiveness of MZWD for the treatment of early RA. Therefore, a parallel-group randomized controlled trial was designed to evaluate the efficacy and safety of MZWD combined with methotrexate on early RA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified Zhiwang Decoction Combined with Methotrexate | Experimental | Drug: Modified Zhiwang Decoction Combined with methotrexate |
| Methotrexate | Active comparator | Drug: Methotrexate |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 16-70 years old;
- Patients who meet the diagnostic criteria of 2010 ACR/EULAR .
- Patients who meet the diagnostic criteria of cold pattern.
- Disease activity score(DAS28) ≤5.2.
Key exclusion criteria (7 listed)
- Patients accompanied with other rheumatic diseases or severe pain due to other medical conditions, such as diabetic pain or post-herpetic neuralgia;
- Patients with joint dysfunction and the X-ray score of wrists is grade IV;
- Patients accompanied with mental and psychological disorders such as cognitive impairment, depression, anxiety, physical dysfunction, cerebral infarction, cerebral hemorrhage, epilepsy, TIA, myelitis, demyelinating disease and other central nervous system diseases.
- Patients accompanied with organ injury or malignant tumors, disorders of the cardiovascular system, liver(ALT/AST>3 times higher than the upper limit of normal), kidneys(Ccr<60ml/min), brain, or hematopoietic system.
- 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 |
|---|---|---|
| Modified Zhiwang Decoction Combined with methotrexateModified Zhiwang Decoction 100 ml (twice, per day) and methotrexate (7.5-15mg, once a week) for 12 weeks. | Drug | Modified Zhiwang Decoction Combined with Methotrexate |
| MethotrexateMethotrexate(7.5-15mg, once a week) for 12 weeks. | Drug | Methotrexate |
Primary outcome
DAS28 based on erythrocyte sedimentation rate scores
Time frame: 12 weeks
DAS28 is widely accepted to evaluate RA disease activity and consists of number of tender joints out of 28, number of swollen joints out of 28, ESR and the patient's global assessment of disease activity.
5 secondary outcomes
Fatigue scale-14
Time frame: 12 weeks
Visual analogue scale pain scores
Time frame: 12 weeks
Traditional chinese medicine symptom scores
Time frame: 12 weeks
Erythrocyte sedimentation rate
Time frame: 12 weeks
C-reactive protein
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Derived from this study: PubMed 38238175Zhang N, Zhang LB, Wang Z, Lan TY, Wang JP, Xiao C, Tao QW, Xu Y. Efficacy and safety of the modified Zhiwang decoction combined with methotrexate in early rheumatoid arthritis: study protocol for a randomised controlled trial. BMJ Open. 2024 Jan 18;14(1):e076571. doi: 10.1136/bmjopen-2023-076571.
- 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.
Yuan Xu study chair
China-Japan Friendship Hospital
Cheng Xiao study director
China-Japan Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Modified Zhiwang Decoction Combined with methotrexate and Methotrexate in people with Arthritis, Rheumatoid, run by Beijing University of 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 7 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 25 May 2023. 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. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Liu-bo Zhang (86-10-84205067, 597810955@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DAS28 based on erythrocyte sedimentation rate scores (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05508815, which also lists 1 linked publication.
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 25 May 2023.