NCT02484508

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
220

participants targeted

Target at P75+ for phase_4 knee-osteoarthritis

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 16, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 29, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

June 29, 2015

Status Verified

June 1, 2015

Enrollment Period

1 year

First QC Date

June 16, 2015

Last Update Submit

June 24, 2015

Conditions

Knee Osteoarthritis

Keywords

Guli capsuleknee osteoarthritisChanging of WOMAC and VAS score

Outcome Measures

Primary Outcomes (1)

  • Osteoarthritis index on the Western Ontario and McMaster Universities Osteoarthritis Index

    4 weeks

Secondary Outcomes (2)

  • Pain Scores on the Visual Analog Scale

    4 weeks

  • Number of Participants with Adverse Events as a Measure of Safety

    4 weeks

Study Arms (2)

Guli capsule

EXPERIMENTAL

Guli capsule, the tested drug of this study

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

Drug: Kangguzengsheng capsule

Interventions

Guli capsuleDRUG

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

Also known as: GL capsule
Guli capsule
Kangguzengsheng capsuleDRUG

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

Also known as: KGZS capsule
Kangguzengsheng capsule

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +2 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wangjing Hospital, Chinese Academy of Traditional Chinese Medicine

Beijing, Beijing Municipality, 100102, China

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Weiheng Chen, MD Dr.

    ICMJE

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Weiheng Chen, MD Dr.

CONTACT

+861084739047weihchenwj@126.com

Jiuyi Chen, MD Dr.

CONTACT

+868515609789jiuyichen@sina.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2015

First Posted

June 29, 2015

Study Start

March 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

June 29, 2015

Record last verified: 2015-06

Locations

CN(1)