NCT03932019

Brief Summary

This study is to investigate the efficacy and safety of Jitongning Tablet in improving joint function and pain symptoms in active axial spondyloarthritis (SpA) patients and to explore the optimal dosage.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
238

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 30, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

June 11, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2021

Completed
Last Updated

November 21, 2022

Status Verified

November 1, 2022

Enrollment Period

2 years

First QC Date

April 26, 2019

Last Update Submit

November 16, 2022

Conditions

Spondyloarthritis

Keywords

Jitongning Tablet, Spondyloarthritis

Outcome Measures

Primary Outcomes (1)

  • ASAS 20 response

    The percentage of subjects who achieved ASAS 20 response at 12th weeks

    12 weeks

Secondary Outcomes (7)

  • BASDAI

    4 weeks,8weeks,12weeks

  • BASFI

    4 weeks,8weeks,12weeks

  • Spinal pain

    4 weeks,8weeks,12weeks

  • PGA

    4 weeks,8weeks,12weeks

  • TCM syndrome scores

    4 weeks,8weeks,12weeks

  • +2 more secondary outcomes

Study Arms (3)

Jitongning tablet High dose group

EXPERIMENTAL

Jitongning tablet,3tablets,bid,po

Drug: Jitongning tablet(High-dose )

Jitongning tablet Low dose group

EXPERIMENTAL

Jitongning tablet,2tablets,bid,po Jitongning tablet placebo,1tablet,bid,po

Drug: Jitongning tablet(Low-dose )

Placebo Comparator controlled group

PLACEBO COMPARATOR

Placebo Comparator: Jitongning tablet placebo,3tablets,bid,po

Drug: Placebo

Interventions

Jitongning tablet(High-dose )DRUG

Jitongning tablet,3tablets,bid,treat 12 weeks

Also known as: Jitongning tablet,3tablets
Jitongning tablet High dose group
Jitongning tablet(Low-dose )DRUG

Jitongning tablet,2tablets,bid,treat 12 weeks Jitongning tablet placebo,1tablet,bid,treat 12 weeks

Also known as: Jitongning tablet,2tablets,Jitongning tablet placebo,1tablet,
Jitongning tablet Low dose group
PlaceboDRUG

Jitongning tablet placebo,3tablets,bid,treat 12 weeks

Also known as: Jitongning tablet placebo,3tablets
Placebo Comparator controlled group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men or women aged 18 to 65 years old (including 18 and 65) ;
  • Meeting the diagnostic criteria for active axial SpA according to the the ASAS classification 2009, defined as satisfied 2 of the following:
  • BASDAI score ≥ 4;
  • In the assessment of pain numerical rating scale (NRS), spine pain NRS ≥ 4;
  • Meeting the standard of TCM syndrome diagnosis for kidney yang deficiency and biood stasis stagnating syndrome;
  • Sacroiliac arthritis of CT categories I(A)\~Ⅲ(B) (including I(A) and Ⅲ(B));
  • Human leukocyte antigen B27 (HLA-B27) is positive;
  • C-reactive protein (CRP)/hypersensitive C-reactive protein (hsCRP) and/or erythrocyte sedimentation rate raised;
  • Voluntary signing of informed consent.

You may not qualify if:

  • Those who use NSAIDs in the first 2 weeks of randomization;
  • In the first 4 weeks of randomization, take disease-modifying antirheumatic Chinese herbal medicine or Chemical drugs (such as sulfasalazine ,methotrexate, leflunomide, Chloroquine, Total glycosides of Tripterygium, Cyclophosphamide, Azathioprine, etc),opioid analgesics(Methadone, Morphine, etc.) ,systemic glucocorticoid therapy;
  • In the first 3 months of randomization, take biological agents that have been used for spinal arthritis;
  • Those who have undergone spinal surgery or joint surgery within 8 weeks before randomization;
  • Patients who received intra-articular injection, spinal or paravertebral injection of corticosteroids within the first 6 months of randomization;
  • The spine is completely stiff (fused);
  • Any Other rheumatic immune system diseases or immunodeficiency syndromes such as ulcerative colitis, psoriasis, uveitis, etc.
  • Those who have a fertility requirement within 6 months;
  • Women during pregnancy and lactation;
  • Suspected or indeed drug use, substance abuse, alcoholism;
  • In the first 3 months of randomization, take the test or in progress;
  • Serious cardiovascular, Liver , kidney, brain, mental, neurological disorders that affect informed consent and/or adverse event expression or observation;
  • Abnormal liver function(the AST or ALT value is above the upper limit of the normal); Abnormal renal function (serum creatinine is above the upper limit of normal);
  • Due to other circumstances, the investigator considered it inappropriate for the participants.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Hefei, Anhui, China

Location

The First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine

Guangzhou, Guangdong, China

Location

Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

The First Affiliated Hospital of hunan Medical University

Changsha, Hunan, China

Location

Jiangsu Province Hospital of Integrated Traditional Chinese and Western Medicine

Nanjing, Jiangsu, China

Location

Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Jinan, Shandong, China

Location

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, China

Location

The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, China

Location

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Location

Yunnan Province Hospital of Traditional Chinese Medicine

Kunming, Yunnan, China

Location

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, China

Location

MeSH Terms

Conditions

Spondylarthritis

Interventions

jitongning

Condition Hierarchy (Ancestors)

SpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint Diseases

Study Officials

  • Rui Liu

    Tasly Group, Co. Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2019

First Posted

April 30, 2019

Study Start

June 11, 2019

Primary Completion

June 20, 2021

Study Completion

August 20, 2021

Last Updated

November 21, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(11)