NCT04480359

Brief Summary

The purpose of this study is to determine whether Bawei Shenqi Pill is effective in the treatment of active ankylosing spondylitis (AS).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2017

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

October 1, 2017

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

July 16, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 21, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

August 14, 2020

Status Verified

July 1, 2020

Enrollment Period

2.9 years

First QC Date

July 16, 2020

Last Update Submit

August 13, 2020

Conditions

Ankylosing Spondylitis

Keywords

Bawei Shenqi Pillankylosing spondylitisclinical research

Outcome Measures

Primary Outcomes (5)

  • BASDAI

    Bath Ankylosing Spondylitis Disease Activity Index

    12weeks

  • BASFI

    Bath Ankylosing Spondylitis Functional Index

    12weeks

  • CRP

    C-reactive protein

    12weeks

  • ESR

    Erythrocyte sedimentation rate

    12weeks

  • Range of motion

    occipital wall distance, chest expansion distance, finger ground distance, Schober test

    12weeks

Secondary Outcomes (1)

  • SF-36

    at baseline and at 3 months

Study Arms (2)

Bawei Shenqi group

ACTIVE COMPARATOR

participants should administrate both Bawei Shenqi Pill and Meloxicam tablets

Drug: Bawei Shenqi PillDrug: Meloxicam

placebo group

PLACEBO COMPARATOR

participants should administrate both Bawei Shenqi Pill placebo and Meloxicam tablets

Drug: Bawei Shenqi Pill placeboDrug: Meloxicam

Interventions

Bawei Shenqi PillDRUG

5.1g, once a day, 3month, oral

Also known as: Experimental:Bawei Shenqi group
Bawei Shenqi group
Bawei Shenqi Pill placeboDRUG

5.1g, once a day, 3month, oral

Also known as: Placebo Comparator: placebo group
placebo group
MeloxicamDRUG

7.5mg, once a day, 3 month, oral

Also known as: Experimental:Bawei Shenqi group, Placebo Comparator: placebo group
Bawei Shenqi groupplacebo group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Compliance with New York standards revised in 1984
  • Syndrome differentiation of traditional Chinese medicine for deficiency of kidney-yang
  • to 70 years of age, male and female
  • Being able to understand or sign an informed consent form

You may not qualify if:

  • Other spondyloarthropathy that does not meet the diagnostic criteria of ankylosing spondylitis, and TCM syndrome differentiation does not belong to kidney-yang deficiency type.
  • Age is out of range
  • Do not agree to participate in this topic or can not participate in the whole process
  • Complicated with other rheumatic diseases or other seronegative spondyloarthropathy.
  • Pregnant, lactating women and patients with serious visceral diseases, mental disorders and severe extraarticular manifestations, such as heart, lung, liver, kidney or hematopoietic system.
  • Have had myocardial infarction or stroke, congestive heart failure and active digestive tract ulcer patients.
  • Those who had received other research drugs three months before screening.
  • Inability or unwillingness to provide informed consent or failure to comply with test requirements.
  • The researchers believe that it is not suitable for the owners of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200030, China

RECRUITING

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Meloxicam

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Intervention Hierarchy (Ancestors)

ThiazinesSulfur CompoundsOrganic ChemicalsThiazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Jianchun Mao, master

CONTACT

86-18917763231mjcct2018@163.com

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
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

July 16, 2020

First Posted

July 21, 2020

Study Start

October 1, 2017

Primary Completion

August 30, 2020

Study Completion

September 30, 2020

Last Updated

August 14, 2020

Record last verified: 2020-07

Locations

CN(1)