Compliance of Traditional Chinese Medicine in Young Patients With Rheumatic Diseases

March 31, 2017 updated by: Yang Min, Chengdu PLA General Hospital
To evaluate the compliance of traditional Chinese medicine (TCM) in young people with Chronic rheumatic disease

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610083
        • General Hospital of Chengdu Military Area Command PLA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patient-tailored anti-arthritis herbs
patient use tailored anti-arthritis herbs
Other: patient-tailored anti-arthritis herbs
patient use tailored anti-arthritis herbs
Active Comparator: patient-tailored DMARDs
Patients use tailored DMARDs
Other: patient-tailored DMARDs
patient use tailored disease-modifying antirheumatic drugs
Other Names:
  • patient-tailored disease-modifying antirheumatic drugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes from baseline in HBCS(Hill-Bone Compliance Scale) score at 48 weeks
Time Frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
at 0 week, 12 weeks, 24 weeks, 48 weeks
Changes from baseline in MARS(Medication Adherence Rating Scale) score at 48 weeks
Time Frame: at 0 week, 12 weeks, 24 weeks, 48 weeks
at 0 week, 12 weeks, 24 weeks, 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chengdu PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Anticipated)

January 1, 2022

Study Completion (Anticipated)

February 1, 2022

Study Registration Dates

First Submitted

October 2, 2014

First Submitted That Met QC Criteria

October 8, 2014

First Posted (Estimate)

October 9, 2014

Study Record Updates

Last Update Posted (Actual)

April 4, 2017

Last Update Submitted That Met QC Criteria

March 31, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT20141003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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