NCT03173027

Brief Summary

Knee osteoarthritis (KOA) is known as degenerative joint disease, which is the most common form of arthritis and the leading cause of disability, loss of function and pain worldwide. Effective therapy to manage RA is still lack at present. Fangji Huangqi pill (FHP) is a Chinese medicine which has been widely used in treating KOA in China for hundreds of years to relieve pain, reduce swelling and protect the affected joints from further degeneration. However, no certain evidence to show the effect of FHP for the management of active KOA.

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
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2018

Shorter than P25 for phase_2

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

First Submitted

Initial submission to the registry

May 30, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 1, 2017

Completed
1.1 years until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

July 17, 2018

Status Verified

July 1, 2018

Enrollment Period

6 months

First QC Date

May 30, 2017

Last Update Submit

July 13, 2018

Conditions

Fangji Huangqi PillKnee Osteoarthritis

Outcome Measures

Primary Outcomes (4)

  • change of the visual analogue scale (VAS)

    at 1 month

  • change of the Western Ontario and McMaster university of orthopedic index

    at 1 month

  • change of the Lequesne index

    at 1 month

  • change of the 6 minutes walk test

    at 1 month

Secondary Outcomes (11)

  • change of the visual analogue scale (VAS)

    from baseline to 2 weeks

  • change of the visual analogue scale (VAS)

    from baseline to 12 weeks

  • change of the Western Ontario and McMaster university of orthopedic index

    from baseline to 2 weeks

  • change of the Western Ontario and McMaster university of orthopedic index

    from baseline to 12 weeks

  • change of the Lequesne index

    from baseline to 2 weeks

  • +6 more secondary outcomes

Study Arms (2)

Experimental group

EXPERIMENTAL

Drug: Fangji Huangqi pill 4g, twice a day, one month, oral Drug: Mobic 7.5mg, once a day, one month, oral participants should administrate both pill and Mobic

Drug: Fangji Huangqi pill or Fangji Huangqi pill placebo

Placebo group

PLACEBO COMPARATOR

Drug: Fangji Huangqi pill placebo 4g, twice a day, one month, oral Drug: Mobic 7.5mg, once a day, one month, oral participants should administrate both pill placebo and Mobic

Drug: Fangji Huangqi pill or Fangji Huangqi pill placebo

Interventions

Fangji Huangqi pill or Fangji Huangqi pill placeboDRUG

For the treatment group (Fangji Huangqi pill group), patients will administrate Fangji Huangqi pill (4 g) in 200 milliliter hot water as the instruction and take the solution orally twice a day for 1 month. While patients in the placebo group will take Fangji Huangqi pill placebo as the same way as the Fangji Huangqi pill group. Besides that, both groups will administrate Mobic (7.5 mg once a day) in addition.

Experimental groupPlacebo group

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meet the diagnostic criteria for knee osteoarthritis (American College of Rheumatology criteria)
  • Grade 0-3 on the Kellgren-Lawrence grading system
  • No serious medical history
  • No known drug allergies
  • No steroids, glucosamine, chondroitin sulfate, sodium hyaluronate before Fangji Huangqi pill treatment within 1 month

You may not qualify if:

  • Combined with other disease such as rheumatoid arthritis, lupus arthritis and et. al
  • Grade 4 on the Kellgren-Lawrence grading system
  • Allergy to study drug
  • Participating in other clinical trial
  • Unwilling to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Longhua Hospital, Shanghai University of TCM

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Central Study Contacts

Yongjun Wang, Doctor

CONTACT

86-189177763018yjwang8888@126.com

Qianqian Liang, Doctor

CONTACT

86-021-64875390

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical research base of Traditional Chinese Medicine

Study Record Dates

First Submitted

May 30, 2017

First Posted

June 1, 2017

Study Start

July 1, 2018

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

July 17, 2018

Record last verified: 2018-07

Locations

CN(1)