Knee OsteoarthritisPhase 2NCT03586700
Based on the Ultrasound Evaluating the Effect of Xiaozhong Fang Particles for Knee Osteoarthritic With Synovial Fluid
A Phase 2 study testing Xiao zhong fang granules and Short wave infrared radiation in people with Knee Osteoarthritis, run by Beijing University of Chinese Medicine at 1 site in China.
Trial summary
This study is a randomized, single blind, controlled trial. Aim to compare the effectiveness (especially the absorption degree of the synovial effusion measured by B ultrasonic) of the treatment group with the control group. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Xiao zhong fang granules and Short wave infrared radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2017to 31 Oct 2020
- Phase
- Phase 2
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1) the American Society of Rheumatology established the diagnostic criteria for knee OA in 2001;
- 2) Kellgren/Lawrence score of knee joint grade as I,II and early III.
- 3) According to "Principles of clinical guidance for new drugs of traditional Chinese Medicine ",diagnosed as "Xi Bi Disease".
- 4) Patients with informed consent.
- 5)Blood and urine routine tests, liver and kidney functions, electrocardiogram were normal before recruitment.
- 6) Patients were not treated with NSAIDS drugs or hormone drugs, and no patients were treated with drugs related to this disease at least 2 weeks.
Who cannot join
- 1)Patients suffer from other rheumatic and metabolic diseases such as gout, rheumatoid arthritis, diabetes and so on.
- 2) Patients with knee joint inflammatory infection, such as suppurative and nonspecific.
- 3)Patients accompanied by traumatic synovitis, Villonodular pigmented synovitis, synovial membrane of the knee is the main lesion.
- 4) Patients with informed consent.
- 5)The color of joint fluid of patients' knees is pink or other color or cloudy; the white blood cell counts > 1000 /mm3 or with crystal in the joint fluid.
- 6)Patients blood RF > 30IU/ml, ESR > 20mm/h, CRP > 10mg/L.
- 7)Patients combined with severe cardiovascular, cerebrovascular, liver, kidney and other primary diseases and mental diseases.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Dongzhimen Hospital Beijing University of Chinese Medicine
Beijing, Bejiing, 100700
DUODUO LI, MASTER, 0086 10 65250460, tarako@163.com
CHANGHE YU, PHD, 0086 13810786345, yakno2@163.com
About this study
This study is a randomized, single blind, controlled trial. Aim to compare the effectiveness (especially the absorption degree of the synovial effusion measured by B ultrasonic) of the treatment group with the control group. The treatment group was given Xiao zhong fang granules orally and short wave infrared radiation and the control group was given the placebo Xiao zhong fang granules orally and short wave infrared radiation. To evaluate the clinical efficacy of the Chinese medicine in the treatment of the synovial effusion of knee osteoarthritis.
- Conditions
- Knee Osteoarthritis
- Being tested
- Xiao zhong fang granules, Short wave infrared radiation, Placebo Xiao zhong fang granules
- Keywords
- Knee Osteoarthritis, Synovium effusion, RCT, 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.
Xiao zhong fang granulesDrug
Chinese medicine Xiao zhong fang was Professor Sun Chengxiang's experience formula in Massage Department of Dongzhimen Hospital. The function of the formula is to activate blood circulation and dredge collaterals, tonifying kidney and promoting dampness to soothe the liver and nourish tendons.
Short wave infrared radiationRadiation
Short waves infrared radiation treatment every other day, ensure 3 times in 7 days, 7 days for a course of treatment, continuously for 4 courses.
Placebo Xiao zhong fang granulesDrug
Made of starch,dextrin and edible pigment from Dongzhimen Hospital of Beijing university of chinese medicine.
| Study group | Role | What they receive |
|---|---|---|
| Xiao zhong fang granules | Experimental | Xiao zhong fang granules were made from Smilax glabra 20g, Paris polyphylla 10g, Alisma orientale15g, Plantago15g, Peach kernel 10g, safflower 10g, radices cyathulae10g,fructus chaenomeles lagenaria 10g, corydalis tuber 10g, radix clematis 10g, radices paeoniae alba 10g, glycyrrhiza 10g. Granules 6 days for one course, continuously taking two courses, interval of 1 day, and then take 2 courses. Short wave infrared radiation treatment every other day, ensure 3 times in 7 days, 7 days for a course of treatment, continuously for 4 courses. Receives: Drug: Xiao zhong fang granules; Radiation: Short wave infrared radiation |
| Placebo Xiao zhong fang granules | Placebo comparator | Placebo Xiao zhong fang granules were made by the same institution. Placebo granules 6 days for one course, continuously taking two courses, interval of 1 day, and then take 2 courses. Short wave infrared radiation treatment every other day, ensure 3 times in 7 days, 7 days for a course of treatment, continuously for 4 courses. Receives: Radiation: Short wave infrared radiation; Drug: Placebo Xiao zhong fang granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walther grading of synovial effusion of Knee joint
The Walther grading standard of the synovial effusion of the knee joint (measuring the anterior and posterior diameter of the effusion): the 0 level is the joint cavity without effusion or the expansion of joint capsule<2mm; the grade I is a small amount of effusion, the expansion of joint capsule is 2mm-5mm; the grade II is a medium amount of effusion, the expansion of joint capsule is 6mm-10mm; the grade III is a large amount of effusion, and the joint capsule expands >10mm.
Measured: After treatment(28days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2018
- Study start15 Sep 2017
- Primary completion31 Aug 2020 (estimated)
- Study completion31 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mei han, Beijing University of Chinese Medicine
- Investigators
- DUODUO LI, MASTER, Principal investigator, Dongzhimen Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03586700
- Sponsor's protocol ID
- QN2016-03
- Status last verified
- Jul 2018
- First submitted
- 25 May 2018
- Last updated
- 16 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Based on the Ultrasound Evaluating the Effect of Xiaozhong Fang Particles for Knee Osteoarthritic With Synovial Fluid
- ClinicalTrials.gov ID
- NCT03586700
- Acronym / sponsor ID
- QN2016-03
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee Osteoarthritis, Synovium effusion, RCT, placebo
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Beijing University of Chinese MedicineUniversity, hospital or other
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 31 Oct 2020 (estimated)
- First posted
- 16 Jul 2018 (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.
This study is a randomized, single blind, controlled trial. Aim to compare the effectiveness (especially the absorption degree of the synovial effusion measured by B ultrasonic) of the treatment group with the control group. The treatment group was given Xiao zhong fang granules orally and short wave infrared radiation and the control group was given the placebo Xiao zhong fang granules orally and short wave infrared radiation. To evaluate the clinical efficacy of the Chinese medicine in the treatment of the synovial effusion of knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xiao zhong fang granules | Experimental | Drug: Xiao zhong fang granules, Radiation: Short wave infrared radiationXiao zhong fang granules were made from Smilax glabra 20g, Paris polyphylla 10g, Alisma orientale15g, Plantago15g, Peach kernel 10g, safflower 10g, radices cyathulae10g,fructus chaenomeles lagenaria 10g, corydalis tuber 10g, radix clematis 10g, radices paeoniae alba 10g, glycyrrhiza 10g. Granules 6 days for one course, continuously taking two courses, interval of 1 day, and then take 2 courses. Short wave infrared radiation treatment every other day, ensure 3 times in 7 days, 7 days for a course of treatment, continuously for 4 courses. |
| Placebo Xiao zhong fang granules | Placebo comparator | Radiation: Short wave infrared radiation, Drug: Placebo Xiao zhong fang granulesPlacebo Xiao zhong fang granules were made by the same institution. Placebo granules 6 days for one course, continuously taking two courses, interval of 1 day, and then take 2 courses. Short wave infrared radiation treatment every other day, ensure 3 times in 7 days, 7 days for a course of treatment, continuously for 4 courses. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 1) the American Society of Rheumatology established the diagnostic criteria for knee OA in 2001;
- 2) Kellgren/Lawrence score of knee joint grade as I,II and early III.
- 3) According to "Principles of clinical guidance for new drugs of traditional Chinese Medicine ",diagnosed as "Xi Bi Disease".
- 4) Patients with informed consent.
- 5)Blood and urine routine tests, liver and kidney functions, electrocardiogram were normal before recruitment.
Key exclusion criteria (7 listed)
- 1)Patients suffer from other rheumatic and metabolic diseases such as gout, rheumatoid arthritis, diabetes and so on.
- 2) Patients with knee joint inflammatory infection, such as suppurative and nonspecific.
- 3)Patients accompanied by traumatic synovitis, Villonodular pigmented synovitis, synovial membrane of the knee is the main lesion.
- 4) Patients with informed consent.
- 5)The color of joint fluid of patients' knees is pink or other color or cloudy; the white blood cell counts > 1000 /mm3 or with crystal in the joint fluid.
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 |
|---|---|---|
| Xiao zhong fang granulesChinese medicine Xiao zhong fang was Professor Sun Chengxiang's experience formula in Massage Department of Dongzhimen Hospital. The function of the formula is to activate blood circulation and dredge collaterals, tonifying kidney and promoting dampness to soothe the liver and nourish tendons. | Drug | Xiao zhong fang granules |
| Short wave infrared radiationShort waves infrared radiation treatment every other day, ensure 3 times in 7 days, 7 days for a course of treatment, continuously for 4 courses. | Radiation | Placebo Xiao zhong fang granules, Xiao zhong fang granules |
| Placebo Xiao zhong fang granulesMade of starch,dextrin and edible pigment from Dongzhimen Hospital of Beijing university of chinese medicine. | Drug | Placebo Xiao zhong fang granules |
Primary outcome
Walther grading of synovial effusion of Knee joint
Time frame: After treatment(28days)
The Walther grading standard of the synovial effusion of the knee joint (measuring the anterior and posterior diameter of the effusion): the 0 level is the joint cavity without effusion or the expansion of joint capsule<2mm; the grade I is a small amount of effusion, the expansion of joint capsule is 2mm-5mm; the grade II is a medium amount of effusion, the expansion of joint capsule is 6mm-10mm; the grade III is a large amount of effusion, and the joint capsule expands >10mm.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2018.
- Individual participant dataSharing planned: Undecided
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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.
DUODUO LI, MASTER principal investigator
Dongzhimen Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Xiao zhong fang granules and Short wave infrared radiation in people with Knee Osteoarthritis, run by Beijing University of Chinese Medicine 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 6 inclusion and 7 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 16 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 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.
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 MEI HAN, PHD (0086 13401131731, hanmeizoujin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walther grading of synovial effusion of Knee joint (time frame: After treatment(28days)). 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 16 Jul 2018.