A Study of Comparing Overall Improvement of Patients With Spondyloarthritis Treated With Jitongning Tablets and Placebo

Ankylosing Spondylitis Clinical Trial

Official title:

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial Protocol of the Efficacy and Safety of Jitongning Tablets for Treating Spondyloarthritis (Kidney Yang Deficiency and Blood Stasis Obstruction)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06000956
• Other study ID #: TSL-TCM-JTNP-?
• Status: Recruiting
• Phase: Phase 3
• Start date: September 15, 2023
• Est. completion date: August 15, 2026

Study information

• Verified date: August 2023
• Source: Tasly Pharmaceutical Group Co., Ltd
• Contact: Wei Liu
• Phone: 022-27432680
• Email: fengshiliuwei[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is evaluating the efficacy and safety of Jitongning tablets in participant population. The main questions it aims to answer are:

• Based on the proportion of participants who achieved improvement in ASAS20, evaluate whether the efficacy of Jitongning tablets is superior to placebo in active ax-SpA adult participants.

• Evaluate the efficacy of Jitongning tablets in improving other key functions and symptom outcomes.

• Evaluating the safety of Jitongning tablets in adult ax-SpA participants. Participants will

1. take orally Jitongning tablets or a simulated agent of Jitongning tablets.

2. Receive examinations and follow-up visits.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 408
• Est. completion date: August 15, 2026
• Est. primary completion date: August 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

All of the following standards must be met:

1. Age range from 18 to 65 years old (including 18 and 65 years old), regardless of gender;

2. Meets the diagnostic criteria for axial osteoarthritis recommended by ASAS in 2009, and the condition is in an active phase. The criteria for determining disease activity are to meet two criteria: Bass ankylosing spondylitis disease activity index (BASDAI) = 40mm (0-100mm, evaluated using VAS); Spinal pain score = 40mm (0-100mm, evaluated using VAS);

3. Conforming to the traditional Chinese medicine syndrome differentiation standards for kidney yang deficiency and blood stasis obstruction syndrome;

4. CT examination of sacroiliac arthritis grades I (A) to II (B) (both included);

5. Human leukocyte antigen B27 (HLA-B27) is positive;

6. Elevated C-reactive protein (CRP)/hypersensitive C-reactive protein (hsCRP) and/or erythrocyte sedimentation rate (ESR);

7. Voluntarily participate in this clinical trial and sign an informed consent form.

Exclusion Criteria:

Those who meet any of the following criteria cannot be included in this experiment:

1. Received non-steroidal anti-inflammatory drugs within 2 weeks before enrollment;

2. Within 4 weeks before enrollment, he received traditional Chinese patent medicines and simple preparations or traditional Chinese medicine decoction, chemical drugs (such as sulfasalazine, methotrexate, leflunomide, hydroxychloroquine, cyclophosphamide, azathioprine, etc.), opioid analgesics (such as methadone, morphine, etc.), JAK inhibitor drugs (such as tofatib, etc.), and systemic glucocorticoid treatment;

3. Received spinal or joint surgery treatment within 8 weeks prior to enrollment;

4. Within 12 weeks prior to enrollment, biological agents with therapeutic effects on spinal arthritis have been used;

5. Within 6 months prior to enrollment, corticosteroid injections were received into the joint cavity or spine/paravertebral area;

6. CT indicates disappearance of sacroiliac joint space or complete spinal rigidity;

7. Subjects diagnosed with other rheumatic immune system diseases or immune deficiency syndrome, such as active ulcerative colitis, psoriasis, uveitis, etc;

8. Those who have fertility requirements within six months;

9. Pregnant or lactating women;

10. Suspected or actual drug, substance, or alcohol abuse;

11. Within 3 months prior to the trial or currently participating in clinical trials;

12. Serious heart, liver, kidney, brain, mental, and neurological disorders that affect informed consent and/or expression or observation of adverse events;

13. Abnormal liver function (elevated levels of alanine or alanine aminotransferase above the upper limit of normal values); Abnormal renal function (serum creatinine levels above the upper limit of normal values);

14. The researchers believe that it is not suitable to participate in this experiment.

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylarthritis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Drug:
• Jitongning tablets
The participants took orally three tablets of Jitongning tablets, twice a day, for 8 consecutive weeks.
• a simulated agent of Jitongning tablets
The participants took orally three tablets of a simulated agent of Jitongning tablets, twice a day, for 8 consecutive weeks.

Locations

Country	Name	City	State
China	Beijing Hospital of Traditional Chinese Medicine, Capital Medical University	Beijing	Beijing
China	Dongfang Hospital, Beijing University of Chinese Medicine	Beijing	Beijing
China	Yunnan Province Hospital of Traditional Chinese Medicine	Kunming	Yunnan
China	The First Hospital of Lanzhou University	Lanzhou	Gansu
China	The First Affiliated Hospital of Henan University of Science and Technology	Luoyang	Henan
China	Affiliated Hospital of North Sichuan Medical College	Nanchong	Sichuan
China	The First Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Suzhou Hospital of Traditional Chinese Medicine	Suzhou	Jiangsu
China	The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine	Tianjin	Tianjin
China	Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tasly Pharmaceutical Group Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ASAS20	Proportion of subjects who achieved improvement in ASAS20 at week 8 of treatment.	8 weeks