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Compliance of Traditional Chinese Medicine in Young Patients With Rheumatic Diseases

Sponsor
Chengdu PLA General Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02260323
Collaborator
(none)
300
Enrollment
1
Location
2
Arms
88
Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: patient-tailored anti-arthritis herbs
  • Other: patient-tailored DMARDs
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Supportive Care
Study Start Date :
Oct 1, 2014
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Feb 1, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes from baseline in HBCS(Hill-Bone Compliance Scale) score at 48 weeks [at 0 week, 12 weeks, 24 weeks, 48 weeks]

    2. Changes from baseline in MARS(Medication Adherence Rating Scale) score at 48 weeks [at 0 week, 12 weeks, 24 weeks, 48 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 General Hospital of Chengdu Military Area Command PLA Chengdu Sichuan China 610083

    Sponsors and Collaborators

    • Chengdu PLA General Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yang Min, Ph.D, Chengdu PLA General Hospital
    ClinicalTrials.gov Identifier:
    NCT02260323
    Other Study ID Numbers:
    • CT20141003
    First Posted:
    Oct 9, 2014
    Last Update Posted:
    Apr 4, 2017
    Last Verified:
    Mar 1, 2017
    Additional relevant MeSH terms:
    Rheumatic Diseases
    Collagen Diseases
    Antirheumatic Agents

    Study Results

    No Results Posted as of Apr 4, 2017