NCT02260323

Brief Summary

To evaluate the compliance of traditional Chinese medicine (TCM) in young people with Chronic rheumatic disease

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
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Longer than P75 for not_applicable

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, 2014

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 2, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 9, 2014

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

7.3 years

First QC Date

October 2, 2014

Last Update Submit

March 31, 2017

Conditions

Chronic Rheumatic Diseases

Outcome Measures

Primary Outcomes (2)

  • Changes from baseline in HBCS(Hill-Bone Compliance Scale) score at 48 weeks

    at 0 week, 12 weeks, 24 weeks, 48 weeks

  • Changes from baseline in MARS(Medication Adherence Rating Scale) score at 48 weeks

    at 0 week, 12 weeks, 24 weeks, 48 weeks

Study Arms (2)

patient-tailored anti-arthritis herbs

EXPERIMENTAL

patient use tailored anti-arthritis herbs

Other: patient-tailored anti-arthritis herbs

patient-tailored DMARDs

ACTIVE COMPARATOR

Patients use tailored DMARDs

Other: patient-tailored DMARDs

Interventions

patient-tailored anti-arthritis herbsOTHER

patient use tailored anti-arthritis herbs

patient-tailored anti-arthritis herbs
patient-tailored DMARDsOTHER

patient use tailored disease-modifying antirheumatic drugs

Also known as: patient-tailored disease-modifying antirheumatic drugs
patient-tailored DMARDs

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • were between 18 and 35 years of age
  • without use of TCM in the previous 3 months
  • and had a Steinbrocker functional status of class I, II, or III

You may not qualify if:

  • previous general health conditions disallowed their use of TCM
  • were pregnant
  • lack of motivation, remote from home, time-consuming,intervention, or other personal difficulties

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital of Chengdu Military Area Command PLA

Chengdu, Sichuan, 610083, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D

Study Record Dates

First Submitted

October 2, 2014

First Posted

October 9, 2014

Study Start

October 1, 2014

Primary Completion

January 1, 2022

Study Completion

February 1, 2022

Last Updated

April 4, 2017

Record last verified: 2017-03

Locations

CN(1)