Multi-center Clinical Study of Guli Capsules in the Treatment of Knee Osteoarthritis

Sponsor

Guizhou Bailing Group Pharmaceutical Co Ltd (Industry)

Overall Status

Unknown status

CT.gov ID

NCT02484508

Collaborator

Wangjing Hospital, China Academy of Chinese Medical Sciences (Other), The First Affiliated Hospital of Guiyang College of Traditional Chinese Medicine (Other), People's Hospital of Guizhou Province (Other)

220

Enrollment

Location

Arms

Duration (Months)

18.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis	Drug: Guli capsule Drug: Kangguzengsheng capsule	Phase 4

Detailed Description

Guli capsule, an approved Chinese patent drug, its main indications are for rheumatism, rheumatoid arthritis.

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

Study Type:

Interventional

Anticipated Enrollment :

220 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double Blind, Single Simulation, Parallel Controlled, Multi-center Clinical Study of Guli Capsules in the Treatment of Knee Osteoarthritis

Study Start Date :

Mar 1, 2015

Anticipated Primary Completion Date :

Mar 1, 2016

Anticipated Study Completion Date :

Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Guli capsule Guli capsule, the tested drug of this study	Drug: Guli capsule Guli capsule,as the experimental drug,is taken 3 grains each time, 3 time per day Other Names: GL capsule
Active Comparator: Kangguzengsheng capsule Kangguzengsheng capsule, a CFDA approved drug for articular genu osteoarthritis,is adopted as active comparator in this study	Drug: Kangguzengsheng capsule Kangguzengsheng capsule, as the active comparator, is taken 3 grains each time, 3 time per day Other Names: KGZS capsule

Arm

Intervention/Treatment

Experimental: Guli capsule

Guli capsule, the tested drug of this study

Drug: Guli capsule

Guli capsule,as the experimental drug,is taken 3 grains each time, 3 time per day

Other Names:

GL capsule

Active Comparator: Kangguzengsheng capsule

Kangguzengsheng capsule, a CFDA approved drug for articular genu osteoarthritis,is adopted as active comparator in this study

Drug: Kangguzengsheng capsule

Kangguzengsheng capsule, as the active comparator, is taken 3 grains each time, 3 time per day

Other Names:

KGZS capsule

Outcome Measures

Primary Outcome Measures

Osteoarthritis index on the Western Ontario and McMaster Universities Osteoarthritis Index [4 weeks]

Secondary Outcome Measures

Pain Scores on the Visual Analog Scale [4 weeks]
Number of Participants with Adverse Events as a Measure of Safety [4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wangjing Hospital, Chinese Academy of Traditional Chinese Medicine	Beijing	Beijing	China	100102

Sponsors and Collaborators

Guizhou Bailing Group Pharmaceutical Co Ltd
Wangjing Hospital, China Academy of Chinese Medical Sciences
The First Affiliated Hospital of Guiyang College of Traditional Chinese Medicine
People's Hospital of Guizhou Province