Fangji Huangqi PillPhase 2/3NCT03173027
The Efficacy of the Traditional Chinese Medicine Fangji Huangqi Pill Combined With Mobic on Active Knee Osteoarthritis
A Phase 2/3 study of Fangji Huangqi Pill and Knee Osteoarthritis, run by Cui xuejun at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Fangji Huangqi Pill, Knee Osteoarthritis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jul 2018to 31 Dec 2018
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Qianqian Liang, Doctor contact
China1 site, 1 recruiting
- Recruiting
Longhua Hospital, Shanghai University of TCM
Shanghai, Shanghai Municipality, 200032
Qianqian Liang, Doctor, 86-021-64875390, liangqianqiantcm@126.com
Qiong Wang, 86-13671779096, 13671779096@163.com
About this study
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
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.
Read the 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.
- Conditions
- Fangji Huangqi Pill, Knee Osteoarthritis
- Being tested
- Fangji Huangqi pill or Fangji Huangqi pill placebo
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Fangji Huangqi pill or Fangji Huangqi pill placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of the visual analogue scale (VAS)
Measured: at 1 month
change of the Western Ontario and McMaster university of orthopedic index
Measured: at 1 month
change of the Lequesne index
Measured: at 1 month
change of the 6 minutes walk test
Measured: at 1 month
Secondary outcomes (11)
change of the visual analogue scale (VAS)
Measured: from baseline to 2 weeks
change of the visual analogue scale (VAS)
Measured: from baseline to 12 weeks
change of the Western Ontario and McMaster university of orthopedic index
Measured: from baseline to 2 weeks
change of the Western Ontario and McMaster university of orthopedic index
Measured: from baseline to 12 weeks
change of the Lequesne index
Measured: from baseline to 2 weeks
change of the Lequesne index
Measured: from baseline to 12 weeks
change of the 6 minutes walk test
Measured: from baseline to 2 weeks
change of the 6 minutes walk test
Measured: from baseline to 12 weeks
change score of the Short Form 36-item Health Survey Questionnaire (SF-36)
Measured: from baseline to 2 weeks
change score of the Short Form 36-item Health Survey Questionnaire (SF-36)
Measured: from baseline to 4 weeks
change score of the Short Form 36-item Health Survey Questionnaire (SF-36)
Measured: from baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study startJul 2018 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fangji Huangqi PillStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cui xuejun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Cui xuejun, Shanghai University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173027
- Sponsor's protocol ID
- FHP
- Status last verified
- Jul 2018
- First submitted
- 30 May 2017
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03173027
- Acronym / sponsor ID
- FHP
- Conditions
- Fangji Huangqi Pill, Knee Osteoarthritis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cui xuejunUniversity, hospital or other
- Study start
- Jul 2018 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 1 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Fangji Huangqi pill or Fangji Huangqi pill placeboDrug: 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 |
| Placebo group | Placebo comparator | Drug: Fangji Huangqi pill or Fangji Huangqi pill placeboDrug: 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 |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fangji Huangqi pill or Fangji Huangqi pill placeboFor 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. | Drug | Experimental group, Placebo group |
Primary outcome
change of the visual analogue scale (VAS)
Time frame: at 1 month
change of the Western Ontario and McMaster university of orthopedic index
Time frame: at 1 month
change of the Lequesne index
Time frame: at 1 month
change of the 6 minutes walk test
Time frame: at 1 month
11 secondary outcomes
change of the visual analogue scale (VAS)
Time frame: from baseline to 2 weeks
change of the visual analogue scale (VAS)
Time frame: from baseline to 12 weeks
change of the Western Ontario and McMaster university of orthopedic index
Time frame: from baseline to 2 weeks
change of the Western Ontario and McMaster university of orthopedic index
Time frame: from baseline to 12 weeks
change of the Lequesne index
Time frame: from baseline to 2 weeks
change of the Lequesne index
Time frame: from baseline to 12 weeks
change of the 6 minutes walk test
Time frame: from baseline to 2 weeks
change of the 6 minutes walk test
Time frame: from baseline to 12 weeks
change score of the Short Form 36-item Health Survey Questionnaire (SF-36)
Time frame: from baseline to 2 weeks
change score of the Short Form 36-item Health Survey Questionnaire (SF-36)
Time frame: from baseline to 4 weeks
change score of the Short Form 36-item Health Survey Questionnaire (SF-36)
Time frame: from baseline to 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qianqian Liang, Doctor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study of Fangji Huangqi Pill and Knee Osteoarthritis, run by Cui xuejun at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yongjun Wang, Doctor (86-189177763018, yjwang8888@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of the visual analogue scale (VAS) (time frame: at 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2018.