- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02260323
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
-
-
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
|
patient use tailored anti-arthritis herbs
|
Active Comparator: patient-tailored DMARDs
Patients use tailored DMARDs
|
patient use tailored disease-modifying antirheumatic drugs
Other Names:
|
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
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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