Rheumatoid ArthritisNCT07115641
Clinical Trial of Huoluo Pills Combined With Iguratimod Tablets in the Treatment of Rheumatoid Arthritis
A study testing Huoluo Pills and Iguratimod Tablets in people with Rheumatoid Arthritis, run by Wangjing Hospital, China Academy of Chinese Medical Sciences.
Trial summary
This study aims to systematically evaluate the efficacy and safety of Huoluo Pills combined with Iguratimod Tablets in the treatment of rheumatoid arthritis (RA). A total of 240 patients with RA belonging to the syndromes of Wind - Damp Obstruction or Cold - Damp Obstruction will be enrolled in 8 centers (randomly… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Huoluo Pills and Iguratimod Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 11 Aug 2025to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Subjects who meet the Western medicine classification criteria for rheumatoid arthritis (RA) launched by the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) in 2010 and have been clearly diagnosed with RA.
- Subjects who meet the diagnostic criteria for traditional Chinese medicine syndromes of "Wind-Dampness Obstruction Syndrome (Main symptoms: ① Joint pain and swelling wandering; ② Joint pain and swelling intermittent. Secondary symptoms: ① Aversion to wind or sweating; ② Headache; ③ Heaviness of the limbs. Tongue and pulse manifestations: Pale red tongue thin white coating slippery or floating pulse. Diagnosis can be made by having 2 main symptoms or 1 main symptom + 2 secondary symptoms combined with the tongue and pulse manifestations)" or "Cold-Dampness Obstruction Syndrome (Main symptoms: ① Cold joint pain the joints feel cold to the touch and the skin color is not red; ② The pain worsens when exposed to cold and alleviates when warmed. Secondary symptoms: ① Joint stiffness limited flexion and extension; ② Cold limbs or aversion to cold and preference for warmth; ③ Bland taste in the mouth without thirst. Tongue and pulse manifestations: Enlarged tongue body pale tongue white or greasy coating wiry or tight pulse. Diagnosis can be made by having 2 main symptoms or 1 main symptom + 2 secondary symptoms combined with the tongue and pulse manifestations)".
- Subjects with a Disease Activity Score in 28 joints (DAS28) (ESR) score > 2.6 and ≤ 5.1 or a DAS28 (CRP) score > 2.3 and ≤ 4.1.
- Male or female subjects aged ≥ 18 years old and ≤ 70 years old.
- Subjects who have not used iguratimod and Huoluo Pills within 4 weeks before the first administration of the investigational drug.
- If the subject is receiving treatment with traditional disease-modifying antirheumatic drugs (DMARDs) during screening monotherapy with one of methotrexate (MTX) leflunomide or hydroxychloroquine is allowed and the dosage should be stable for at least 12 weeks before the first administration of the investigational drug (MTX dosage ≤ 15 mg/week leflunomide ≤ 20 mg/day hydroxychloroquine ≤ 400 mg/day).
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- Subjects who are receiving treatment with non-steroidal anti-inflammatory drugs (NSAIDs) during screening should have a stable dosage for at least 2 weeks before the first administration of the investigational drug and maintain the same dosage during the trial.
- Subjects who are receiving hormone treatment during screening should have a stable condition (limited to oral administration of ≤ 10 mg/d prednisone acetate or equivalent dose) for at least 4 weeks before the first administration of the investigational drug and maintain stable treatment during the trial.
- Subjects who voluntarily agree to participate in this trial sign a written informed consent form are able to follow the visit and related procedures specified in the protocol and have good compliance.
Who cannot join
- Those who have used plant medicine preparations such as Tripterygium glycosides total glucosides of paeony sinomenine or other traditional Chinese medicine preparations that affect the evaluation of the therapeutic effect within 4 weeks before the first administration of the test drug;
- Those who have received intramuscular injection intravenous injection or intra-articular injection of glucocorticoid treatment within 4 weeks before the first administration of the test drug;
- Patients who have received treatment with biological agents within 12 weeks before the first administration of the test drug;
- Those who suffer from active gastrointestinal diseases (such as peptic ulcers) severe interstitial lung diseases low bone marrow function severe cardiovascular and cerebrovascular diseases (such as acute myocardial infarction unstable angina pectoris intracerebral hemorrhage transient ischemic attack) severe organic lesions such as poorly controlled diabetes mellitus or those who have a history of malignant tumors in the past 5 years or those with mental illnesses. ;
- Those known to have tuberculosis HIV hepatitis B hepatitis C syphilis or other active or chronic persistent infections;
- Those who are allergic to the drugs involved in the research protocol or have contraindications to their use;
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- Those who have received live vaccines within 4 weeks before screening or inactivated vaccines within 2 weeks before screening or those who have a vaccination plan during the trial;
- Those with any of the following conditions in the auxiliary examination during screening: 1) AST or ALT > 1.5 times the upper limit of the normal reference value or the estimated glomerular filtration rate (eGFR) ≤ 60 mL/min/1.73m²; 2) Hemoglobin < 90 g/L or white blood cell count < 3.0×10⁹/L or neutrophil count < 1.5×10⁹/L or lymphocyte count < 0.5×10⁹/L or platelet count < 90×10⁹/L;
- Pregnant or lactating women those with a fertility plan or those planning to donate sperm or eggs;
- Those who are participating in other clinical trials before screening;
- Those whom the investigator deems to have other factors that make them unsuitable to participate in this trial.
About this study
Official title: A Multicenter Clinical Randomized Controlled Trial on the Efficacy and Safety of Huoluo Pills Combined With Iguratimod Tablets in the Treatment of Rheumatoid Arthritis
This study aims to systematically evaluate the efficacy and safety of Huoluo Pills combined with Iguratimod Tablets in the treatment of rheumatoid arthritis (RA). A total of 240 patients with RA belonging to the syndromes of Wind - Damp Obstruction or Cold - Damp Obstruction will be enrolled in 8 centers (randomly assigned to groups). The experimental group will receive oral Huoluo Pills combined with Iguratimod Tablets, while the control group will receive oral Iguratimod Tablets alone. Both groups will be administered continuously for 12 weeks.
Primary Efficacy Index: The proportion of ACR20 responders in each group at the end of treatment.
Read more
Key Secondary Efficacy Index: The change in DAS28 (CRP) score from baseline in each group at the end of treatment.
Other Secondary Efficacy Indexes: RF, CRP, ESR, IL - 6, ACR50, ACR70, CDAI, SDAI, HAQ - DI, SF - 36, FACIT - Fatigue, and Traditional Chinese Medicine (TCM) syndrome scores.
Safety Indexes: Physical examination, blood routine, urine routine, blood biochemistry, coagulation function, etc.
This study will investigate the efficacy and safety of Huoluo Pills combined with Iguratimod Tablets in the treatment of RA with Wind - Damp Obstruction or Cold - Damp Obstruction syndromes.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Huoluo Pills, Iguratimod Tablets
- Keywords
- Huoluo Pills, Iguratimod Tablets
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Huoluo PillsDrug
Huoluo Pills: Orally take 1 pill once, twice a day (swallow with warm water)
Iguratimod TabletsDrug
Iguratimod Tablets: Orally take 1 tablet once, twice a day (one tablet in the morning and one in the evening, after meals)
| Study group | Role | What they receive |
|---|---|---|
| Trial group | Experimental | Huoluo Pills + Iguratimod Tablets Receives: Drug: Huoluo Pills; Drug: Iguratimod Tablets |
| Control group | Other | Iguratimod Tablets Receives: Drug: Iguratimod Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects achieving ACR20
ACR20: The improvement degree of the number of tender joints and the number of swollen joints is ≥20%, and the improvement degree of at least 3 items among the remaining 5 items is ≥20%.
Measured: At the end of the treatment (on the 84th day)
Secondary outcomes (29)
The change of Disease Activity Score in 28 Joints-C-Reactive Protein（DAS28-CRP） score compared with the baseline
DAS28-CRP=0.56×sqrt（TJC28）+0.28×sqrt（SJC28）+0.36×ln（CRP+1）+0.014×GH+0.96
- TJC28: Number of tender joints among 28 joints;
- SJC28: Number of swollen joints among 28 joints;
- ESR: Erythrocyte Sedimentation Rate;
- CRP: C-reactive Protein;
- GH: Patient's global assessment of disease activity (VAS score, unit: 100mm).
Disease activity DAS28-CRP thresholds:
- High: > 4.1;
- Moderate: > 2.7 and ≤ 4.1;
- Low: > 2.3 and ≤ 2.7;
- Remission: ≤ 2.3
Measured: At the end of the treatment (on the 84th day)
The proportion of subjects achieving ACR20
ACR20: The improvement degree of the number of tender joints and the number of swollen joints is ≥20%, and the improvement degree of at least 3 items among the remaining 5 items is ≥20%.
Measured: By the 28th day of treatment
The change of Disease Activity Score in 28 Joints-C-Reactive Protein（DAS28-CRP） score compared with the baseline
DAS28-CRP=0.56×sqrt（TJC28）+0.28×sqrt（SJC28）+0.36×ln（CRP+1）+0.014×GH+0.96 - TJC28: Number of tender joints among 28 joints; - SJC28: Number of swollen joints among 28 joints; - ESR: Erythrocyte Sedimentation Rate; - CRP: C-reactive Protein; - GH: Patient's global assessment of disease activity (VAS score, unit: 100mm). Disease activity DAS28-CRP thresholds: - High: > 4.1; - Moderate: > 2.7 and ≤ 4.1; - Low: > 2.3 and ≤ 2.7; - Remission: ≤ 2.3
Measured: By the 28th day of treatment
The remission rate of Disease Activity Score in 28 Joints-C-Reactive Protein（DAS28-CRP）
Measured: When treating up to the 28th and 84th days
The low activity rate of Disease Activity Score in 28 Joints-C-Reactive Protein（DAS28-CRP）
Measured: When treating up to the 28th and 84th days
The remission rate of Disease Activity Score in 28 Joints-Erythrocyte Sedimentation Rate（DAS28-ESR）
Measured: When treating up to the 28th and 84th days
The low activity rate of Disease Activity Score in 28 Joints-Erythrocyte Sedimentation Rate（DAS28-ESR）
Measured: When treating up to the 28th and 84th days
The change of Disease Activity Score in 28 Joints-Erythrocyte Sedimentation Rate（DAS28-ESR） score compared with the baseline
DAS28-ESR=0.56×sqrt（TJC28）+0.28×sqrt（SJC28）+0.70×ln（ESR）+0.014×GH
- TJC28: Number of tender joints among 28 joints;
- SJC28: Number of swollen joints among 28 joints;
- ESR: Erythrocyte Sedimentation Rate;
- CRP: C-reactive Protein;
- GH: Patient's global assessment of disease activity (VAS score, unit: 100mm).
Disease activity DAS28-ESR thresholds:
- High: > 5.1;
- Moderate: > 3.2 and ≤ 5.1;
- Low: > 2.6 and ≤ 3.2;
- Remission: ≤ 2.6
Measured: When treating up to the 28th and 84th days
The proportion of subjects with ACR50
ACR50: The improvement degree of the number of tender joints and the number of swollen joints is ≥50%, and the improvement degree of at least 3 items among the remaining 5 items is ≥50%.
Measured: When treating up to the 28th and 84th days
The proportion of subjects with ACR70
ACR70: The improvement degree of the number of tender joints and the number of swollen joints is ≥70%, and the improvement degree of at least 3 items among the remaining 5 items is ≥70%.
Measured: When treating up to the 28th and 84th days
The proportion of subjects with a CDAI（Clinical Disease Activity Index） score ≤ 10
CDAI=（TJC28+SJC28+GH+EH）/4
- TJC28: Number of tender joints among 28 joints;
- SJC28: Number of swollen joints among 28 joints;
- GH: Patient's global assessment of disease activity (VAS score, unit: 100mm);
- EH: Physician's global assessment of disease activity (VAS score, unit: 100mm).
Disease activity thresholds:
- High: > 22;
- Moderate: > 10 and ≤ 22;
- Low: > 2.8 and ≤ 10;
- Remission: ≤ 2.8.
Measured: When treating up to the 28th and 84th days
The proportion of subjects with a CDAI（Clinical Disease Activity Index） score ≤ 2.8
CDAI=（TJC28+SJC28+GH+EH）/4 - TJC28: Number of tender joints among 28 joints; - SJC28: Number of swollen joints among 28 joints; - GH: Patient's global assessment of disease activity (VAS score, unit: 100mm); - EH: Physician's global assessment of disease activity (VAS score, unit: 100mm). Disease activity thresholds: - High: > 22; - Moderate: > 10 and ≤ 22; - Low: > 2.8 and ≤ 10; - Remission: ≤ 2.8.
Measured: When treating up to the 28th and 84th days
The change of CDAI（Clinical Disease Activity Index） score compared with the baseline
CDAI=（TJC28+SJC28+GH+EH）/4 - TJC28: Number of tender joints among 28 joints; - SJC28: Number of swollen joints among 28 joints; - GH: Patient's global assessment of disease activity (VAS score, unit: 100mm); - EH: Physician's global assessment of disease activity (VAS score, unit: 100mm). Disease activity thresholds: - High: > 22; - Moderate: > 10 and ≤ 22; - Low: > 2.8 and ≤ 10; - Remission: ≤ 2.8.
Measured: When treating up to the 28th and 84th days
The proportion of subjects with an SDAI（Simplified Disease Activity Index） score ≤ 11
SDAI=（TJC28+SJC28+CRP+GH+EH）/5
- TJC28: Number of tender joints among 28 joints;
- SJC28: Number of swollen joints among 28 joints;
- CRP: C-reactive Protein;
- GH: Patient's global assessment of disease activity (VAS score, unit: 100mm);
- EH: Physician's global assessment of disease activity (VAS score, unit: 100mm).
Disease activity thresholds:
- High: > 26;
- Moderate: > 11 and ≤ 26;
- Low: > 3.3 and ≤ 11;
- Remission: ≤ 3.3.
Measured: When treating up to the 28th and 84th days
The proportion of subjects with an SDAI （Simplified Disease Activity Index）score ≤ 3.3
SDAI=（TJC28+SJC28+CRP+GH+EH）/5
- TJC28: Number of tender joints among 28 joints;
- SJC28: Number of swollen joints among 28 joints;
- CRP: C-reactive Protein;
- GH: Patient's global assessment of disease activity (VAS score, unit: 100mm);
- EH: Physician's global assessment of disease activity (VAS score, unit: 100mm).
Disease activity thresholds:
- High: > 26;
- Moderate: > 11 and ≤ 26;
- Low: > 3.3 and ≤ 11;
- Remission: ≤ 3.3.
Measured: When treating up to the 28th and 84th days
Change in SDAI （Simplified Disease Activity Index）score from baseline
SDAI=（TJC28+SJC28+CRP+GH+EH）/5
- TJC28: Number of tender joints among 28 joints;
- SJC28: Number of swollen joints among 28 joints;
- CRP: C-reactive Protein;
- GH: Patient's global assessment of disease activity (VAS score, unit: 100mm);
- EH: Physician's global assessment of disease activity (VAS score, unit: 100mm).
Disease activity thresholds:
- High: > 26;
- Moderate: > 11 and ≤ 26;
- Low: > 3.3 and ≤ 11;
- Remission: ≤ 3.3.
Measured: When treating up to the 28th and 84th days
The change of HAQ-DI（Health Assessment Questionnaire-Disability Index Score） score compared with the baseline
The HAQ-DI scale consists of 20 questions, each scored on a 4-point scale: 0 points for "no difficulty", 1 point for "some difficulty", 2 points for "great difficulty", and 3 points for "unable to perform". The total score is 0-60 points.The higher the score, the worse the function or mood.
Measured: When treating up to the 28th and 84th days
The changes of the scores of each dimension of the quality of life (SF-36,36-item Short-Form) compared with the baseline respectively.
- Calculation of raw scores: For each question, assign the corresponding score according to the answer option. Usually, the options are arranged in the order from "best" to "worst" and given corresponding score values (such as a 5-point scale, 4-point scale, or 3-point scale). Calculate the total raw score for each dimension.
- Calculation of converted scores:
Since the number of questions and score ranges in different dimensions may vary, it is necessary to convert raw scores into standard scores (i.e., converted scores) for comparison and analysis.
The calculation method of converted scores is usually: (Raw score - Minimum possible raw score of the dimension) / (Maximum possible raw score of the dimension - Minimum possible raw score of the dimension) × 100.
In this way, the converted score of each dimension will be standardized between 0 and 100, facilitating comparison and analysis.
A higher score indicates a better state of health.
Measured: When treating up to the 28th and 84th days
The change of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score in disease treatment compared with the baseline.
The FACIT-Fatigue consists of 13 questions, each scored on a 5-point scale (0-4 points), with a total score ranging from 0 to 52 points. A higher score indicates a more severe degree of fatigue in the patient.
Measured: When treating up to the 28th and 84th days
The change of TCM syndrome score compared with the baseline and the effective rate
The scale scores corresponding to the primary symptoms are 0, 2, 4, and 6 points respectively, and the scale scores corresponding to the secondary symptoms are 0, 1, 2, and 3 points respectively. A higher score indicates more obvious symptoms.
Criteria for Therapeutic Effect of TCM Syndromes:
- Clinical cure: TCM-related syndromes disappear or basically disappear, and the reduction of syndrome scores is ≥95%;
- Marked effect: TCM-related syndromes are significantly improved, with a reduction of syndrome scores >95% and ≥70%;
- Effective: TCM-related syndromes are improved, with a reduction of syndrome scores >70% and ≥30%;
- Ineffective: TCM-related syndromes show no significant improvement or even worsen, with a reduction of syndrome scores <30%.
Total effective rate = [(Number of cured cases + Number of markedly effective cases + Number of effective cases) / Total number of cases] × 100%
Measured: When treating up to the 28th and 84th days
The change of the Visual Analogue Scale (VAS) score of the doctor's overall assessment of disease activity (EH) compared with the baseline.
The VAS score ranges from 0 to 100 mm, where 0 represents no pain or no activity, and 100 represents the most severe.
Measured: When treating up to the 28th and 84th days
The change of the Visual Analogue Scale (VAS) score of the subjects' assessment of articular pain (PtAAP) compared with the baseline.
The VAS score ranges from 0 to 100 mm, where 0 represents no pain or no activity, and 100 represents the most severe.
Measured: When treating up to the 28th and 84th days
The change of the Visual Analogue Scale (VAS) score of the subjects' overall assessment of disease activity (GH) compared with the baseline.
The VAS score ranges from 0 to 100 mm, where 0 represents no pain or no activity, and 100 represents the most severe.
Measured: When treating up to the 28th and 84th days
The change of the detected value of C-reactive protein (CRP) compared with the baseline.
Measured: When treating up to the 28th and 84th days
The change of the detected value of erythrocyte sedimentation rate (ESR) compared with the baseline
Measured: When treating up to the 28th and 84th days
The change of rheumatoid factor (RF) compared with the baseline
Measured: By the 84th day of treatment
The change of the inflammatory factor interleukin - 6 (IL - 6) compared with the baseline.
Measured: By the 84th day of treatment
The changes of coagulation - related indexes compared with the baseline.
Measured: By the 84th day of treatment
The dosage of Loxoprofen Sodium Tablets
Measured: When treating up to the 28th and 84th days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start11 Aug 2025 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion31 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
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wangjing Hospital, China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Science, Beijing Tongrentang Co., Ltd., Beijing Leadingpharm Medicine Technology Development, Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, The First Affiliated Hospital of Henan university of CM, Xi'an No.5 Hospital, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Shaanxi Hospital of Traditional Chinese Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07115641
- Sponsor's protocol ID
- leadingpharm2025002
- Other IDs
- ITMCTR2025000953, MR-11-25-036909
- Status last verified
- Jun 2025
- First submitted
- 21 Jul 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Randomized Controlled Trial on the Efficacy and Safety of Huoluo Pills Combined With Iguratimod Tablets in the Treatment of Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT07115641
- Acronym / sponsor ID
- leadingpharm2025002
- Conditions
- Rheumatoid Arthritis
- Keywords
- Huoluo Pills, Iguratimod Tablets
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Wangjing Hospital, China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Institute of Science, Beijing Tongrentang Co., Ltd., Beijing Leadingpharm Medicine Technology Development, Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine, The Second Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine, The First Affiliated Hospital of Henan university of CM, Xi'an No.5 Hospital, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Shaanxi Hospital of Traditional Chinese Medicine
- Study start
- 11 Aug 2025 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 11 Aug 2025 (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 aims to systematically evaluate the efficacy and safety of Huoluo Pills combined with Iguratimod Tablets in the treatment of rheumatoid arthritis (RA). A total of 240 patients with RA belonging to the syndromes of Wind - Damp Obstruction or Cold - Damp Obstruction will be enrolled in 8 centers (randomly assigned to groups). The experimental group will receive oral Huoluo Pills combined with Iguratimod Tablets, while the control group will receive oral Iguratimod Tablets alone. Both groups will be administered continuously for 12 weeks.
Primary Efficacy Index: The proportion of ACR20 responders in each group at the end of treatment.
Key Secondary Efficacy Index: The change in DAS28 (CRP) score from baseline in each group at the end of treatment.
Other Secondary Efficacy Indexes: RF, CRP, ESR, IL - 6, ACR50, ACR70, CDAI, SDAI, HAQ - DI, SF - 36, FACIT - Fatigue, and Traditional Chinese Medicine (TCM) syndrome scores.
Safety Indexes: Physical examination, blood routine, urine routine, blood biochemistry, coagulation function, etc.
This study will investigate the efficacy and safety of Huoluo Pills combined with Iguratimod Tablets in the treatment of RA with Wind - Damp Obstruction or Cold - Damp Obstruction syndromes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trial group | Experimental | Drug: Huoluo Pills, Drug: Iguratimod TabletsHuoluo Pills + Iguratimod Tablets |
| Control group | Other | Drug: Iguratimod TabletsIguratimod Tablets |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects who meet the Western medicine classification criteria for rheumatoid arthritis (RA) launched by the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) in 2010 and have been clearly diagnosed with RA.
- Subjects who meet the diagnostic criteria for traditional Chinese medicine syndromes of "Wind-Dampness Obstruction Syndrome (Main symptoms: ① Joint pain and swelling wandering; ② Joint pain and swelling intermittent. Secondary symptoms: ① Aversion to wind or sweating; ② Headache; ③ Heaviness of the limbs. Tongue and pulse manifestations: Pale red tongue thin white coating slippery or floating pulse. Diagnosis can be made by having 2 main symptoms or 1 main symptom + 2 secondary symptoms combined with the tongue and pulse manifestations)" or "Cold-Dampness Obstruction Syndrome (Main symptoms: ① Cold joint pain the joints feel cold to the touch and the skin color is not red; ② The pain worsens when exposed to cold and alleviates when warmed. Secondary symptoms: ① Joint stiffness limited flexion and extension; ② Cold limbs or aversion to cold and preference for warmth; ③ Bland taste in the mouth without thirst. Tongue and pulse manifestations: Enlarged tongue body pale tongue white or greasy coating wiry or tight pulse. Diagnosis can be made by having 2 main symptoms or 1 main symptom + 2 secondary symptoms combined with the tongue and pulse manifestations)".
- Subjects with a Disease Activity Score in 28 joints (DAS28) (ESR) score > 2.6 and ≤ 5.1 or a DAS28 (CRP) score > 2.3 and ≤ 4.1.
- Male or female subjects aged ≥ 18 years old and ≤ 70 years old.
- Subjects who have not used iguratimod and Huoluo Pills within 4 weeks before the first administration of the investigational drug.
Key exclusion criteria (11 listed)
- Those who have used plant medicine preparations such as Tripterygium glycosides total glucosides of paeony sinomenine or other traditional Chinese medicine preparations that affect the evaluation of the therapeutic effect within 4 weeks before the first administration of the test drug;
- Those who have received intramuscular injection intravenous injection or intra-articular injection of glucocorticoid treatment within 4 weeks before the first administration of the test drug;
- Patients who have received treatment with biological agents within 12 weeks before the first administration of the test drug;
- Those who suffer from active gastrointestinal diseases (such as peptic ulcers) severe interstitial lung diseases low bone marrow function severe cardiovascular and cerebrovascular diseases (such as acute myocardial infarction unstable angina pectoris intracerebral hemorrhage transient ischemic attack) severe organic lesions such as poorly controlled diabetes mellitus or those who have a history of malignant tumors in the past 5 years or those with mental illnesses. ;
- Those known to have tuberculosis HIV hepatitis B hepatitis C syphilis or other active or chronic persistent infections;
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 |
|---|---|---|
| Huoluo PillsHuoluo Pills: Orally take 1 pill once, twice a day (swallow with warm water) | Drug | Trial group |
| Iguratimod TabletsIguratimod Tablets: Orally take 1 tablet once, twice a day (one tablet in the morning and one in the evening, after meals) | Drug | Control group, Trial group |
Primary outcome
The proportion of subjects achieving ACR20
Time frame: At the end of the treatment (on the 84th day)
ACR20: The improvement degree of the number of tender joints and the number of swollen joints is ≥20%, and the improvement degree of at least 3 items among the remaining 5 items is ≥20%.
29 secondary outcomes
The change of Disease Activity Score in 28 Joints-C-Reactive Protein（DAS28-CRP） score compared with the baseline
Time frame: At the end of the treatment (on the 84th day)
The proportion of subjects achieving ACR20
Time frame: By the 28th day of treatment
The change of Disease Activity Score in 28 Joints-C-Reactive Protein（DAS28-CRP） score compared with the baseline
Time frame: By the 28th day of treatment
The remission rate of Disease Activity Score in 28 Joints-C-Reactive Protein（DAS28-CRP）
Time frame: When treating up to the 28th and 84th days
The low activity rate of Disease Activity Score in 28 Joints-C-Reactive Protein（DAS28-CRP）
Time frame: When treating up to the 28th and 84th days
The remission rate of Disease Activity Score in 28 Joints-Erythrocyte Sedimentation Rate（DAS28-ESR）
Time frame: When treating up to the 28th and 84th days
The low activity rate of Disease Activity Score in 28 Joints-Erythrocyte Sedimentation Rate（DAS28-ESR）
Time frame: When treating up to the 28th and 84th days
The change of Disease Activity Score in 28 Joints-Erythrocyte Sedimentation Rate（DAS28-ESR） score compared with the baseline
Time frame: When treating up to the 28th and 84th days
The proportion of subjects with ACR50
Time frame: When treating up to the 28th and 84th days
The proportion of subjects with ACR70
Time frame: When treating up to the 28th and 84th days
The proportion of subjects with a CDAI（Clinical Disease Activity Index） score ≤ 10
Time frame: When treating up to the 28th and 84th days
The proportion of subjects with a CDAI（Clinical Disease Activity Index） score ≤ 2.8
Time frame: When treating up to the 28th and 84th days
The change of CDAI（Clinical Disease Activity Index） score compared with the baseline
Time frame: When treating up to the 28th and 84th days
The proportion of subjects with an SDAI（Simplified Disease Activity Index） score ≤ 11
Time frame: When treating up to the 28th and 84th days
The proportion of subjects with an SDAI （Simplified Disease Activity Index）score ≤ 3.3
Time frame: When treating up to the 28th and 84th days
Change in SDAI （Simplified Disease Activity Index）score from baseline
Time frame: When treating up to the 28th and 84th days
The change of HAQ-DI（Health Assessment Questionnaire-Disability Index Score） score compared with the baseline
Time frame: When treating up to the 28th and 84th days
The changes of the scores of each dimension of the quality of life (SF-36,36-item Short-Form) compared with the baseline respectively.
Time frame: When treating up to the 28th and 84th days
The change of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) score in disease treatment compared with the baseline.
Time frame: When treating up to the 28th and 84th days
The change of TCM syndrome score compared with the baseline and the effective rate
Time frame: When treating up to the 28th and 84th days
The change of the Visual Analogue Scale (VAS) score of the doctor's overall assessment of disease activity (EH) compared with the baseline.
Time frame: When treating up to the 28th and 84th days
The change of the Visual Analogue Scale (VAS) score of the subjects' assessment of articular pain (PtAAP) compared with the baseline.
Time frame: When treating up to the 28th and 84th days
The change of the Visual Analogue Scale (VAS) score of the subjects' overall assessment of disease activity (GH) compared with the baseline.
Time frame: When treating up to the 28th and 84th days
The change of the detected value of C-reactive protein (CRP) compared with the baseline.
Time frame: When treating up to the 28th and 84th days
The change of the detected value of erythrocyte sedimentation rate (ESR) compared with the baseline
Time frame: When treating up to the 28th and 84th days
The change of rheumatoid factor (RF) compared with the baseline
Time frame: By the 84th day of treatment
The change of the inflammatory factor interleukin - 6 (IL - 6) compared with the baseline.
Time frame: By the 84th day of treatment
The changes of coagulation - related indexes compared with the baseline.
Time frame: By the 84th day of treatment
The dosage of Loxoprofen Sodium Tablets
Time frame: When treating up to the 28th and 84th days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- 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.
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 Huoluo Pills and Iguratimod Tablets in people with Rheumatoid Arthritis, run by Wangjing Hospital, China Academy of Chinese Medical Sciences.
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 11 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: opening soon, as of the sponsor's last update on 11 Aug 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
The proportion of subjects achieving ACR20 (time frame: At the end of the treatment (on the 84th day)). 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 11 Aug 2025.