Back to resultsCompliance of Traditional Chinese Medicine in Young Patients With Rheumatic Diseases
Primary Purpose
Chronic Rheumatic Diseases
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
patient-tailored anti-arthritis herbs
patient-tailored DMARDs
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Rheumatic Diseases
Eligibility Criteria
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
Sites / Locations
- General Hospital of Chengdu Military Area Command PLA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
patient-tailored anti-arthritis herbs
patient-tailored DMARDs
Arm Description
patient use tailored anti-arthritis herbs
Patients use tailored DMARDs
Outcomes
Primary Outcome Measures
Changes from baseline in HBCS(Hill-Bone Compliance Scale) score at 48 weeks
Changes from baseline in MARS(Medication Adherence Rating Scale) score at 48 weeks
Secondary Outcome Measures
Full Information
NCT ID
NCT02260323
First Posted
October 2, 2014
Last Updated
March 31, 2017
Sponsor
Chengdu PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02260323
Brief Title
Compliance of Traditional Chinese Medicine in Young Patients With Rheumatic Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
February 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chengdu PLA General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the compliance of traditional Chinese medicine (TCM) in young people with Chronic rheumatic disease
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rheumatic Diseases
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patient-tailored anti-arthritis herbs
Arm Type
Experimental
Arm Description
patient use tailored anti-arthritis herbs
Arm Title
patient-tailored DMARDs
Arm Type
Active Comparator
Arm Description
Patients use tailored DMARDs
Intervention Type
Other
Intervention Name(s)
patient-tailored anti-arthritis herbs
Intervention Description
patient use tailored anti-arthritis herbs
Intervention Type
Other
Intervention Name(s)
patient-tailored DMARDs
Other Intervention Name(s)
patient-tailored disease-modifying antirheumatic drugs
Intervention Description
patient use tailored disease-modifying antirheumatic drugs
Primary Outcome Measure Information:
Title
Changes from baseline in HBCS(Hill-Bone Compliance Scale) score at 48 weeks
Time Frame
at 0 week, 12 weeks, 24 weeks, 48 weeks
Title
Changes from baseline in MARS(Medication Adherence Rating Scale) score at 48 weeks
Time Frame
at 0 week, 12 weeks, 24 weeks, 48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
General Hospital of Chengdu Military Area Command PLA
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610083
Country
China
12. IPD Sharing Statement
Learn more about this trial
Compliance of Traditional Chinese Medicine in Young Patients With Rheumatic Diseases
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