The Efficacy of the Traditional Chinese Medicine Fangji Huangqi Pill Combined With Mobic on Active Knee Osteoarthritis

The Efficacy of the Traditional Chinese Medicine Fangji Huangqi Pill Combined With Mobic on Active Knee Osteoarthritis: a Study Protocol for a Randomized, Controlled Clinical Trial

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.

Study Overview

• Status: Unknown
• Conditions: Knee Osteoarthritis; Fangji Huangqi Pill
• Intervention / Treatment: Drug: Fangji Huangqi pill or Fangji Huangqi pill placebo

Detailed Description

A randomized, double-blind, placebo-controlled clinical trials (RCT) will be conducted to explore whether the FHP could relieve pain and protect joints. 200 participants suffering from KOA will be enrolled and treated with FHP or placebo for 1 month. The primary outcome measures are the Visual analogue scale (VAS), Western Ontario and McMaster university of orthopedic index (WOMAC), the Lequesne index, and MOS Sleep Scale would be measured from the baseline to 1 month. The second outcome measures would be the six minutes walking test, the Short Form 36-item Health Survey (SF- 36), the X-ray of both knees, and the adverse events from the baseline to 2 weeks, 4 weeks, and 12 weeks' follow-up. In addition, the VAS score, the WOMAC score, the Lequesne index, and AIS Sleep Scale from the baseline to 2 weeks and 12 weeks' follow-up are also the second outcome measures.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Longhua Hospital, Shanghai university of TCM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; 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; 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.
Placebo Comparator: Placebo group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
change of the Lequesne index	from baseline to 12 weeks
change of the 6 minutes walk test	from baseline to 2 weeks
change of the 6 minutes walk test	from baseline to 12 weeks
change score of the Short Form 36-item Health Survey Questionnaire (SF-36)	from baseline to 2 weeks
change score of the Short Form 36-item Health Survey Questionnaire (SF-36)	from baseline to 4 weeks
change score of the Short Form 36-item Health Survey Questionnaire (SF-36)	from baseline to 12 weeks

Collaborators and Investigators

• Sponsor: Cui xuejun

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2018
• Primary Completion (Anticipated): December 31, 2018
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: May 30, 2017
• First Submitted That Met QC Criteria: May 30, 2017
• First Posted (Actual): June 1, 2017

Study Record Updates

• Last Update Posted (Actual): July 17, 2018
• Last Update Submitted That Met QC Criteria: July 13, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: FHP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No