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

Primary Purpose

Ankylosing Spondylitis

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Jitongning tablets
a simulated agent of Jitongning tablets
Sponsored by
Tasly Pharmaceutical Group Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: All of the following standards must be met: Age range from 18 to 65 years old (including 18 and 65 years old), regardless of gender; 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); Conforming to the traditional Chinese medicine syndrome differentiation standards for kidney yang deficiency and blood stasis obstruction syndrome; CT examination of sacroiliac arthritis grades I (A) to II (B) (both included); Human leukocyte antigen B27 (HLA-B27) is positive; Elevated C-reactive protein (CRP)/hypersensitive C-reactive protein (hsCRP) and/or erythrocyte sedimentation rate (ESR); 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: Received non-steroidal anti-inflammatory drugs within 2 weeks before enrollment; 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; Received spinal or joint surgery treatment within 8 weeks prior to enrollment; Within 12 weeks prior to enrollment, biological agents with therapeutic effects on spinal arthritis have been used; Within 6 months prior to enrollment, corticosteroid injections were received into the joint cavity or spine/paravertebral area; CT indicates disappearance of sacroiliac joint space or complete spinal rigidity; Subjects diagnosed with other rheumatic immune system diseases or immune deficiency syndrome, such as active ulcerative colitis, psoriasis, uveitis, etc; Those who have fertility requirements within six months; Pregnant or lactating women; Suspected or actual drug, substance, or alcohol abuse; Within 3 months prior to the trial or currently participating in clinical trials; Serious heart, liver, kidney, brain, mental, and neurological disorders that affect informed consent and/or expression or observation of adverse events; 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); The researchers believe that it is not suitable to participate in this experiment.

Sites / Locations

  • Dongfang Hospital, Beijing University of Chinese MedicineRecruiting
  • Beijing Hospital of Traditional Chinese Medicine, Capital Medical UniversityRecruiting
  • The First Hospital of Lanzhou UniversityRecruiting
  • The First Hospital of Hebei Medical UniversityRecruiting
  • The First Affiliated Hospital of Henan University of Science and TechnologyRecruiting
  • Tongji Hospital of Tongji Medical College, Huazhong University of Science and TechnologyRecruiting
  • Suzhou Hospital of Traditional Chinese MedicineRecruiting
  • Affiliated Hospital of North Sichuan Medical CollegeRecruiting
  • The First Affiliated Hospital of Tianjin University of Traditional Chinese MedicineRecruiting
  • Yunnan Province Hospital of Traditional Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Jitongning tablets

a simulated agent of Jitongning tablets

Arm Description

Outcomes

Primary Outcome Measures

ASAS20
Proportion of subjects who achieved improvement in ASAS20 at week 8 of treatment.

Secondary Outcome Measures

Full Information

First Posted
August 9, 2023
Last Updated
September 3, 2023
Sponsor
Tasly Pharmaceutical Group Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT06000956
Brief Title
A Study of Comparing Overall Improvement of Patients With Spondyloarthritis Treated With Jitongning Tablets and Placebo
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2023 (Anticipated)
Primary Completion Date
August 15, 2025 (Anticipated)
Study Completion Date
August 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tasly Pharmaceutical Group Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 take orally Jitongning tablets or a simulated agent of Jitongning tablets. Receive examinations and follow-up visits.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
408 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Jitongning tablets
Arm Type
Experimental
Arm Title
a simulated agent of Jitongning tablets
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Jitongning tablets
Intervention Description
The participants took orally three tablets of Jitongning tablets, twice a day, for 8 consecutive weeks.
Intervention Type
Drug
Intervention Name(s)
a simulated agent of Jitongning tablets
Intervention Description
The participants took orally three tablets of a simulated agent of Jitongning tablets, twice a day, for 8 consecutive weeks.
Primary Outcome Measure Information:
Title
ASAS20
Description
Proportion of subjects who achieved improvement in ASAS20 at week 8 of treatment.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All of the following standards must be met: Age range from 18 to 65 years old (including 18 and 65 years old), regardless of gender; 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); Conforming to the traditional Chinese medicine syndrome differentiation standards for kidney yang deficiency and blood stasis obstruction syndrome; CT examination of sacroiliac arthritis grades I (A) to II (B) (both included); Human leukocyte antigen B27 (HLA-B27) is positive; Elevated C-reactive protein (CRP)/hypersensitive C-reactive protein (hsCRP) and/or erythrocyte sedimentation rate (ESR); 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: Received non-steroidal anti-inflammatory drugs within 2 weeks before enrollment; 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; Received spinal or joint surgery treatment within 8 weeks prior to enrollment; Within 12 weeks prior to enrollment, biological agents with therapeutic effects on spinal arthritis have been used; Within 6 months prior to enrollment, corticosteroid injections were received into the joint cavity or spine/paravertebral area; CT indicates disappearance of sacroiliac joint space or complete spinal rigidity; Subjects diagnosed with other rheumatic immune system diseases or immune deficiency syndrome, such as active ulcerative colitis, psoriasis, uveitis, etc; Those who have fertility requirements within six months; Pregnant or lactating women; Suspected or actual drug, substance, or alcohol abuse; Within 3 months prior to the trial or currently participating in clinical trials; Serious heart, liver, kidney, brain, mental, and neurological disorders that affect informed consent and/or expression or observation of adverse events; 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); The researchers believe that it is not suitable to participate in this experiment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Liu
Phone
022-27432680
Email
fengshiliuwei@163.com
Facility Information:
Facility Name
Dongfang Hospital, Beijing University of Chinese Medicine
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100078
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenna Liu
Phone
010-67689923
Email
dfjgb2019@126.com
Facility Name
Beijing Hospital of Traditional Chinese Medicine, Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xueqi Zhu
Phone
010-52176813
Email
bjzyyygcp@sina.com
Facility Name
The First Hospital of Lanzhou University
City
Lanzhou
State/Province
Gansu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ting Wang
Phone
0931-8356748
Email
ting_w6710@163.com
Facility Name
The First Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wenxiu Si
Phone
0311-87156671
Email
swxlbc@163.com
Facility Name
The First Affiliated Hospital of Henan University of Science and Technology
City
Luoyang
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuntong Zhai
Phone
0379-64830815
Email
1652065260@qq.com
Facility Name
Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang Shu
Phone
027-83663940
Email
tongjigcp@163.com
Facility Name
Suzhou Hospital of Traditional Chinese Medicine
City
Suzhou
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaofeng Zhu
Phone
0512-67872186
Email
szszyyyll@163.com
Facility Name
Affiliated Hospital of North Sichuan Medical College
City
Nanchong
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yan Zeng
Phone
0817-2608120
Email
393241992@qq.com
Facility Name
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
City
Tianjin
State/Province
Tianjin
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Wang
Phone
022-27986257
Email
yfyjdb@163.com
Facility Name
Yunnan Province Hospital of Traditional Chinese Medicine
City
Kunming
State/Province
Yunnan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
An Wang
Phone
0871-63623713
Email
ynzygcp1@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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