Back to resultsMulti-center Clinical Study of Guli Capsules in the Treatment of Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Guli capsule
Kangguzengsheng capsule
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Guli capsule, knee osteoarthritis, Changing of WOMAC and VAS score
Eligibility Criteria
Inclusion Criteria:
- 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
- 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).
Exclusion Criteria:
- 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;
- 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.
Sites / Locations
- Wangjing Hospital, Chinese Academy of Traditional Chinese MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Guli capsule
Kangguzengsheng capsule
Arm Description
Guli capsule, the tested drug of this study
Kangguzengsheng capsule, a CFDA approved drug for articular genu osteoarthritis,is adopted as active comparator in this study
Outcomes
Primary Outcome Measures
Osteoarthritis index on the Western Ontario and McMaster Universities Osteoarthritis Index
Secondary Outcome Measures
Pain Scores on the Visual Analog Scale
Number of Participants with Adverse Events as a Measure of Safety
Full Information
NCT ID
NCT02484508
First Posted
June 16, 2015
Last Updated
June 24, 2015
Sponsor
Guizhou Bailing Group Pharmaceutical Co Ltd
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
1. Study Identification
Unique Protocol Identification Number
NCT02484508
Brief Title
Multi-center Clinical Study of Guli Capsules in the Treatment of Knee Osteoarthritis
Official Title
A Randomized, Double Blind, Single Simulation, Parallel Controlled, Multi-center Clinical Study of Guli Capsules in the Treatment of Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
March 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guizhou Bailing Group Pharmaceutical Co Ltd
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
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Guli capsule, knee osteoarthritis, Changing of WOMAC and VAS score
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Guli capsule
Arm Type
Experimental
Arm Description
Guli capsule, the tested drug of this study
Arm Title
Kangguzengsheng capsule
Arm Type
Active Comparator
Arm Description
Kangguzengsheng capsule, a CFDA approved drug for articular genu osteoarthritis,is adopted as active comparator in this study
Intervention Type
Drug
Intervention Name(s)
Guli capsule
Other Intervention Name(s)
GL capsule
Intervention Description
Guli capsule,as the experimental drug,is taken 3 grains each time, 3 time per day
Intervention Type
Drug
Intervention Name(s)
Kangguzengsheng capsule
Other Intervention Name(s)
KGZS capsule
Intervention Description
Kangguzengsheng capsule, as the active comparator, is taken 3 grains each time, 3 time per day
Primary Outcome Measure Information:
Title
Osteoarthritis index on the Western Ontario and McMaster Universities Osteoarthritis Index
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Pain Scores on the Visual Analog Scale
Time Frame
4 weeks
Title
Number of Participants with Adverse Events as a Measure of Safety
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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).
Exclusion Criteria:
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;
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weiheng Chen, MD Dr.
Phone
+861084739047
Email
weihchenwj@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jiuyi Chen, MD Dr.
Phone
+868515609789
Email
jiuyichen@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weiheng Chen, MD Dr.
Organizational Affiliation
ICMJE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wangjing Hospital, Chinese Academy of Traditional Chinese Medicine
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100102
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weiheng Chen, MD Dr.
Phone
+861084739047
Email
weihchenwj@126.com
First Name & Middle Initial & Last Name & Degree
Jiuyi Chen, MD Dr.
Phone
+868515609789
Email
jiuychen77@sohu.com
First Name & Middle Initial & Last Name & Degree
Weiheng Chen, MD Dr.
First Name & Middle Initial & Last Name & Degree
Jiuyi Chen, MD Dr.
First Name & Middle Initial & Last Name & Degree
Min Huang, MD Dr.
12. IPD Sharing Statement
Learn more about this trial
Multi-center Clinical Study of Guli Capsules in the Treatment of Knee Osteoarthritis
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