Chronic Rheumatic DiseasesNCT02260323
Compliance of Traditional Chinese Medicine in Young Patients With Rheumatic Diseases
A study testing patient-tailored anti-arthritis herbs and patient-tailored DMARDs in people with Chronic Rheumatic Diseases, run by Chengdu PLA General Hospital at 1 site in China.
Trial summary
To evaluate the compliance of traditional Chinese medicine (TCM) in young people with Chronic rheumatic disease Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Chronic Rheumatic Diseases
- What is being tested?
- patient-tailored anti-arthritis herbs and patient-tailored DMARDs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Oct 2014to Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- previous general health conditions disallowed their use of TCM
- were pregnant
- lack of motivation, remote from home, time-consuming,intervention, or other personal difficulties
Trial locations and contacts
1 site in 1 country.
China1 site
General Hospital of Chengdu Military Area Command PLA
Chengdu, Sichuan, 610083
About this study
To evaluate the compliance of traditional Chinese medicine (TCM) in young people with Chronic rheumatic disease
- Conditions
- Chronic Rheumatic Diseases
- Being tested
- patient-tailored anti-arthritis herbs, patient-tailored DMARDs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient-tailored anti-arthritis herbsOther
patient use tailored anti-arthritis herbs
patient-tailored DMARDsOther
Also called patient-tailored disease-modifying antirheumatic drugs
patient use tailored disease-modifying antirheumatic drugs
| Study group | Role | What they receive |
|---|---|---|
| patient-tailored anti-arthritis herbs | Experimental | patient use tailored anti-arthritis herbs Receives: Other: patient-tailored anti-arthritis herbs |
| patient-tailored DMARDs | Active comparator | Patients use tailored DMARDs Receives: Other: patient-tailored DMARDs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in HBCS(Hill-Bone Compliance Scale) score at 48 weeks
Measured: at 0 week, 12 weeks, 24 weeks, 48 weeks
Changes from baseline in MARS(Medication Adherence Rating Scale) score at 48 weeks
Measured: at 0 week, 12 weeks, 24 weeks, 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionJan 2022 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rheumatic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Min, Chengdu PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02260323
- Sponsor's protocol ID
- CT20141003
- Status last verified
- Mar 2017
- First submitted
- 2 Oct 2014
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compliance of Traditional Chinese Medicine in Young Patients With Rheumatic Diseases
- ClinicalTrials.gov ID
- NCT02260323
- Acronym / sponsor ID
- CT20141003
- Conditions
- Chronic Rheumatic Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chengdu PLA General HospitalUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 9 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the compliance of traditional Chinese medicine (TCM) in young people with Chronic rheumatic disease
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient-tailored anti-arthritis herbs | Experimental | Other: patient-tailored anti-arthritis herbspatient use tailored anti-arthritis herbs |
| patient-tailored DMARDs | Active comparator | Other: patient-tailored DMARDsPatients use tailored DMARDs |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- previous general health conditions disallowed their use of TCM
- were pregnant
- lack of motivation, remote from home, time-consuming,intervention, or other personal difficulties
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patient-tailored anti-arthritis herbspatient use tailored anti-arthritis herbs | Other | patient-tailored anti-arthritis herbs |
| patient-tailored DMARDsAlso: patient-tailored disease-modifying antirheumatic drugspatient use tailored disease-modifying antirheumatic drugs | Other | patient-tailored DMARDs |
Primary outcome
Changes from baseline in HBCS(Hill-Bone Compliance Scale) score at 48 weeks
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patient-tailored anti-arthritis herbs and patient-tailored DMARDs in people with Chronic Rheumatic Diseases, run by Chengdu PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline in HBCS(Hill-Bone Compliance Scale) score at 48 weeks (time frame: at 0 week, 12 weeks, 24 weeks, 48 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.