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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-03-31

Brief Summary

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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.

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Detailed Description

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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

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Guli capsule

Guli capsule, the tested drug of this study

Group Type EXPERIMENTAL

Guli capsule

Intervention Type DRUG

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

Kangguzengsheng capsule

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

Group Type ACTIVE_COMPARATOR

Kangguzengsheng capsule

Intervention Type DRUG

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

Interventions

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Guli capsule

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

Intervention Type DRUG

Kangguzengsheng capsule

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

Intervention Type DRUG

Other Intervention Names

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GL capsule KGZS capsule

Eligibility Criteria

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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:

1. most of the time have knee pain nearly a month
2. bone fricative
3. morning stiffness is less than or equal to 30 min
4. age is more than or equal to 38 years
5. bony enlargement. Who meet (1) + (2) or (1) + (4) + (5) can be diagnosed as knee osteoarthritis.
* Radiological criteria:

1. most of the time have knee pain nearly a month
2. the X-ray showed osteophyte formation
3. joint fluid examination confirmed with osteoarthritis
4. age is more than or equal to 40 years
5. morning stiffness is less than or equal to 30 min
6. 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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No