An Early Phase 1 interventional study of Modified Zhiwang Decoction Combined with methotrexate and Methotrexate in Arthritis, Rheumatoid, sponsored by Beijing University of Chinese Medicine. Recruiting at 1 site in China. Open to participants aged 16 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-05-25.
Sponsored by Beijing University of Chinese Medicine · Early Phase 1, Interventional, and Treatment
Among 249 studies in Arthritis, Rheumatoid with a site in China — 63 open to participants now, 73 under way, 4 of them phase 3. Arthritis, Rheumatoid · China.
Among the 249 studies in Arthritis, Rheumatoid with a site in China, this one is the 95th largest by planned enrollment of the 217 interventional ones, is one of 19 that started in 2023, is one of 54 in phase 1, reaches primary completion later than 5 of the 72 other live ones, and was the 151st registered.
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's planned enrollment of 150 is above the median of 96 across 2,220 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →63 of the 249 studies in Arthritis, Rheumatoid with a site in China are open now, in 12 countries. Each count lists the studies.
Of the 293 Arthritis, Rheumatoid studies recruiting now, 150 (51%) set no upper age limit and 109 (37%) stop at 75 or younger; 15 take children under 18; 36 take healthy volunteers.
This study: 16 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →249 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 19 started in 2023.
Median enrollment 134 across the 217 interventional studies, 287 across the 32 observational. Of the 114 that completed or were terminated, 28 (25%) have results posted.
129 of 249 have an industry lead sponsor. The 10 most frequent:
Beijing University of Chinese Medicine is the lead sponsor of 32 studies on the registry; 8 are open to participants now.
Beijing University of Chinese Medicine has 1 study filed under Arthritis, Rheumatoid — fewer than ten, so there is no comparison to draw.
17 of the studies in Arthritis, Rheumatoid with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06887127Phase 3Hangzhou Highlightll Pharmaceutical Co., LtdA Long-term Extension Clinical Study of TLL-018 in Patients With Rheumatoid Arthritis | 2026-12-31 |
| NCT06888960CytoCares IncSafety Study of CC312 in Autoimmune Disease Patients | 2026-11-08 |
| NCT07408024Toll Biotech Co. Ltd. (Beijing)Safety and Efficacy of TollB-001 Tablets in Moderate to Severe Rheumatoid Arthritis | 2026-12 |
| NCT07045896Peking University People's HospitalFucoidan in the Treatment of Active Rheumatoid Arthritis | 2026-12 |
| NCT06945666Jie ChangA Study of Iguratimod in Combination With Tofacitinib in RA Patients | 2027-01-31 |
Among the 249 studies in Arthritis, Rheumatoid with a site in China, from their registry updates:
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Modified Zhiwang Decoction Combined with methotrexate
Drug: Methotrexate
Modified Zhiwang Decoction 100 ml (twice, per day) and methotrexate (7.5-15mg, once a week) for 12 weeks.
Methotrexate(7.5-15mg, once a week) for 12 weeks.
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.
Time frame: 12 weeks
Fatigue scale-14
The fatigue scale-14 is a standardized questionnaire regarding physical and mental fatigue. The higher the score, the greater the fatigue.
Time frame: 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.
Time frame: 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%
Time frame: 12 weeks
Erythrocyte sedimentation rate
Time frame: 12 weeks
C-reactive protein
Time frame: 12 weeks
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2023 (actual). Primary completion is estimated for Dec 2024, 22 months after the start.
Of 148 phase 1 interventional studies under Arthritis, Rheumatoid, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 32. This study's planned 22 months is above that.
How these figures are worked out, and which studies are left out of them.
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Beijing University of Chinese Medicine