Knee OsteoarthritisPhase 4NCT02484508
Multi-center Clinical Study of Guli Capsules in the Treatment of Knee Osteoarthritis
A Phase 4 study testing Guli capsule and Kangguzengsheng capsule in people with Knee Osteoarthritis, run by Guizhou Bailing Group Pharmaceutical Co Ltd at 1 site in China.
Trial summary
Previous study showed that Guli capsule could suppress the adjuvant multiple arthritis; have inhibitory effect on carrageenan gelatinous and formaldehyde foot swelling; improve the symptom of osteoporosis patients; and improve pain and limited joint activities of rheumatoid patients. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Guli capsule and Kangguzengsheng capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- Mar 2015to Mar 2016
- Phase
- Phase 4
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages between 40 and 70 years, both gender
- Kellgren and Lawrence grades of I to III;
- The subjects volunteered participate in the study and complied with the regulations and signed the written consent voluntarily.
- Meet the following clinical and radiological criteria for diagnosis:
- Clinical criteria:
- most of the time have knee pain nearly a month
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- bone fricative
- morning stiffness is less than or equal to 30 min
- age is more than or equal to 38 years
- bony enlargement. Who meet (1) + (2) or (1) + (4) + (5) can be diagnosed as knee osteoarthritis.
- Radiological criteria:
- most of the time have knee pain nearly a month
- the X-ray showed osteophyte formation
- joint fluid examination confirmed with osteoarthritis
- age is more than or equal to 40 years
- morning stiffness is less than or equal to 30 min
- bone fricative. Meet (1) + (2) or (1) + (3) + (5) + (6) or (1) + (4) + (5) + (6).
Who cannot join
- Patient with a history of allergy to similar constituents or chemical components of the drug;
- Patients with limited liver and kidney function;
- Patients with hematopoietic system disease;
- Patients with diabetes, Cushing's syndrome and other endocrine disorders;
- Patients with severe heart and brain disease;
- Patients with low immunity;
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- Patients directly involved with the staff in the study;
- Women during pregnancy or lactation;
- Participating in other clinical studies or Participated in 3 months;
- The investigators judged who be unfit for the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Wangjing Hospital, Chinese Academy of Traditional Chinese Medicine
Beijing, Beijing Municipality, 100102
Weiheng Chen, MD Dr., +861084739047, weihchenwj@126.com
Jiuyi Chen, MD Dr., +868515609789, jiuychen77@sohu.com
About this study
Official title: A Randomized, Double Blind, Single Simulation, Parallel Controlled, Multi-center Clinical Study of Guli Capsules in the Treatment of Knee Osteoarthritis
Previous study showed that Guli capsule could suppress the adjuvant multiple arthritis; have inhibitory effect on carrageenan gelatinous and formaldehyde foot swelling; improve the symptom of osteoporosis patients; and improve pain and limited joint activities of rheumatoid patients.
To further verify the clinical effect of Guli capsule in the treatment of knee osteoarthritis, the investigators perform this multi-center clinical study.
Read the detailed description
Guli capsule, an approved Chinese patent drug, its main indications are for rheumatism, rheumatoid arthritis.
Previous study showed that Guli capsule could suppress the adjuvant multiple arthritis; have inhibitory effect on carrageenan gelatinous and formaldehyde foot swelling; improve the symptom of osteoporosis patients; and improve pain and limited joint activities of rheumatoid patients.
To further verify the clinical effect of Guli capsule in the treatment of knee osteoarthritis, the investigators perform this multi-center clinical study.
- Conditions
- Knee Osteoarthritis
- Being tested
- Guli capsule, Kangguzengsheng capsule
- Keywords
- Guli capsule, knee osteoarthritis, Changing of WOMAC and VAS score
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guli capsuleDrug
Also called GL capsule
Guli capsule,as the experimental drug,is taken 3 grains each time, 3 time per day
Kangguzengsheng capsuleDrug
Also called KGZS capsule
Kangguzengsheng capsule, as the active comparator, is taken 3 grains each time, 3 time per day
| Study group | Role | What they receive |
|---|---|---|
| Guli capsule | Experimental | Guli capsule, the tested drug of this study Receives: Drug: Guli capsule |
| Kangguzengsheng capsule | Active comparator | Kangguzengsheng capsule, a CFDA approved drug for articular genu osteoarthritis,is adopted as active comparator in this study Receives: Drug: Kangguzengsheng capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Osteoarthritis index on the Western Ontario and McMaster Universities Osteoarthritis Index
Measured: 4 weeks
Secondary outcomes (2)
Pain Scores on the Visual Analog Scale
Measured: 4 weeks
Number of Participants with Adverse Events as a Measure of Safety
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guizhou Bailing Group Pharmaceutical Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Wangjing Hospital, China Academy of Chinese Medical Sciences, The First Affiliated Hospital of Guiyang College of Traditional Chinese Medicine, People's Hospital of Anshun City of Guizhou Province
- Responsible party
- Sponsor
- Investigators
- Weiheng Chen, MD Dr., Principal investigator, ICMJE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484508
- Sponsor's protocol ID
- GL-15-01
- Status last verified
- Jun 2015
- First submitted
- 16 Jun 2015
- Last updated
- 29 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Single Simulation, Parallel Controlled, Multi-center Clinical Study of Guli Capsules in the Treatment of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02484508
- Acronym / sponsor ID
- GL-15-01
- Conditions
- Knee Osteoarthritis
- Keywords
- Guli capsule, knee osteoarthritis, Changing of WOMAC and VAS score
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Guizhou Bailing Group Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
- Collaborators
- Wangjing Hospital, China Academy of Chinese Medical Sciences, The First Affiliated Hospital of Guiyang College of Traditional Chinese Medicine, People's Hospital of Anshun City of Guizhou Province
- Study start
- Mar 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 29 Jun 2015 (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.
Previous study showed that Guli capsule could suppress the adjuvant multiple arthritis; have inhibitory effect on carrageenan gelatinous and formaldehyde foot swelling; improve the symptom of osteoporosis patients; and improve pain and limited joint activities of rheumatoid patients.
To further verify the clinical effect of Guli capsule in the treatment of knee osteoarthritis, the investigators perform this multi-center clinical study.
Detailed description
Guli capsule, an approved Chinese patent drug, its main indications are for rheumatism, rheumatoid arthritis.
Previous study showed that Guli capsule could suppress the adjuvant multiple arthritis; have inhibitory effect on carrageenan gelatinous and formaldehyde foot swelling; improve the symptom of osteoporosis patients; and improve pain and limited joint activities of rheumatoid patients.
To further verify the clinical effect of Guli capsule in the treatment of knee osteoarthritis, the investigators perform this multi-center clinical study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guli capsule | Experimental | Drug: Guli capsuleGuli capsule, the tested drug of this study |
| Kangguzengsheng capsule | Active comparator | Drug: Kangguzengsheng capsuleKangguzengsheng capsule, a CFDA approved drug for articular genu osteoarthritis,is adopted as active comparator in this study |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Ages between 40 and 70 years, both gender
- Kellgren and Lawrence grades of I to III;
- The subjects volunteered participate in the study and complied with the regulations and signed the written consent voluntarily.
- Meet the following clinical and radiological criteria for diagnosis:
- Clinical criteria:
Key exclusion criteria (10 listed)
- Patient with a history of allergy to similar constituents or chemical components of the drug;
- Patients with limited liver and kidney function;
- Patients with hematopoietic system disease;
- Patients with diabetes, Cushing's syndrome and other endocrine disorders;
- Patients with severe heart and brain disease;
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 |
|---|---|---|
| Guli capsuleAlso: GL capsuleGuli capsule,as the experimental drug,is taken 3 grains each time, 3 time per day | Drug | Guli capsule |
| Kangguzengsheng capsuleAlso: KGZS capsuleKangguzengsheng capsule, as the active comparator, is taken 3 grains each time, 3 time per day | Drug | Kangguzengsheng capsule |
Primary outcome
Osteoarthritis index on the Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: 4 weeks
2 secondary outcomes
Pain Scores on the Visual Analog Scale
Time frame: 4 weeks
Number of Participants with Adverse Events as a Measure of Safety
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2015.
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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.
Weiheng Chen, MD Dr. principal investigator
ICMJE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Guli capsule and Kangguzengsheng capsule in people with Knee Osteoarthritis, run by Guizhou Bailing Group Pharmaceutical Co Ltd 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 17 inclusion and 10 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 29 Jun 2015. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Weiheng Chen, MD Dr. (+861084739047, weihchenwj@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Osteoarthritis index on the Western Ontario and McMaster Universities Osteoarthritis Index (time frame: 4 weeks). 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 29 Jun 2015.