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

Sponsor

Cui xuejun (Other)

Overall Status

Unknown status

CT.gov ID

NCT03173027

Collaborator

(none)

200

Enrollment

Location

Arms

Anticipated Duration (Months)

33.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fangji Huangqi Pill Knee Osteoarthritis	Drug: Fangji Huangqi pill or Fangji Huangqi pill placebo	Phase 2/Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2018

Anticipated Primary Completion Date :

Dec 31, 2018

Anticipated Study Completion Date :

Dec 31, 2018

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Longhua Hospital, Shanghai University of TCM	Shanghai	Shanghai	China	200032

Sponsors and Collaborators

Cui xuejun

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Cui xuejun, Clinical research base of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine

ClinicalTrials.gov Identifier:

NCT03173027

Other Study ID Numbers:

First Posted:

Jun 1, 2017

Last Update Posted:

Jul 17, 2018

Last Verified:

Jul 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Osteoarthritis

Osteoarthritis, Knee

Study Results

No Results Posted as of Jul 17, 2018