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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02484508
• Other study ID #: GL-15-01
• Status: Recruiting
• Phase: Phase 4
• First received: June 16, 2015
• Last updated: June 24, 2015
• Start date: March 2015
• Est. completion date: March 2016

Study information

• Verified date: June 2015
• Source: Guizhou Bailing Group Pharmaceutical Co Ltd
• Contact: Weiheng Chen, MD Dr.
• Phone: +861084739047
• Email: weihchenwj[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical 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.

To further verify the clinical effect of Guli capsule in the treatment of knee osteoarthritis, the investigators perform this multi-center clinical study.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Guli capsule
Guli capsule,as the experimental drug,is taken 3 grains each time, 3 time per day
• Kangguzengsheng capsule
Kangguzengsheng capsule, as the active comparator, is taken 3 grains each time, 3 time per day

Locations

Country	Name	City	State
China	Wangjing Hospital, Chinese Academy of Traditional Chinese Medicine	Beijing	Beijing

Sponsors (4)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Osteoarthritis index on the Western Ontario and McMaster Universities Osteoarthritis Index		4 weeks	No
Secondary	Pain Scores on the Visual Analog Scale		4 weeks	No
Secondary	Number of Participants with Adverse Events as a Measure of Safety		4 weeks	Yes