Efficacy and Safety of Panlongqi Tablet in Patients With Knee Osteoarthritis
NCT ID: NCT03327012
Last Updated: 2017-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
300 participants
INTERVENTIONAL
2017-11-01
2019-07-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment of Panlongqi Tablet
Patients were treated with Panlongqi Tablet.
Treatment of Panlongqi Tablet
Panlongqi Tablet:1.2g,3times a day, oral, for 4 weeks.
Treatment of Panlongqi Placebo
Patients were treated with Panlongqi Placebo Tablet.
Treatment of Panlongqi placebo
Panlongqi placebo:1.2g,3times a day, oral, for 4 weeks.
Interventions
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Treatment of Panlongqi Tablet
Panlongqi Tablet:1.2g,3times a day, oral, for 4 weeks.
Treatment of Panlongqi placebo
Panlongqi placebo:1.2g,3times a day, oral, for 4 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2\. western medicine diagnosis of knee osteoarthritis, clinical classification for primary.
3.The severity of the imaging classification of K-L≤Ⅲ; 4. treatment VAS pain scores than 40mm (select the subjects most obvious limb pain symptoms).
5\. informed consent form signed by the patient or legal representative.
Exclusion Criteria
2. 4 weeks before the treatment, corticosteroids, non steroidal drugs, intra-articular injections or other drugs to improve the condition (such as cartilage protective agents) were used.
3. Swelling of the knee joint.
4. knee synovial crystalline (joint) inflammation, acute inflammatory arthritis, rheumatoid arthritis, metabolic bone disease, psoriatic arthritis, septic arthritis, systemic lupus erythematosus, Sjogren syndrome, vasculitis and other rheumatic diseases caused by inflammatory arthritis and endocrine diseases caused by.
5. the screening period has any disease history or evidence: The basic of serious cardiovascular and cerebrovascular diseases; An active, recurrent peptic ulcer or other hemorrhagic disease risk; Sales and other serious diseases of digestive system; An associated with malignant tumors, blood, or other serious diseases or system;
6. patients who are unable to cooperate or cooperate with other mental disorders.
7. before the screening, any laboratory test indicators meet the following standards: An admission of liver and kidney function showed that ALT and AST is more than 1.5 times the upper limit of the normal value, Cr is more than 1.2 times the upper limit of normal (Reference Research Center laboratory where the range of normal value); An other clinically significant laboratory abnormalities, and the researchers judged not into the group.
8. allergic constitution or allergic to test seven tablets, excipients or similar ingredients;
9. doubt or indeed history of alcohol and drug abuse;
10. pregnant or lactating women or recent planned pregnancies and those who are reluctant to use contraceptives;
11. participants who participated in other clinical trials within the first 3 months.
12. the researchers believe that patients should not participate in this clinical trial.
40 Years
75 Years
ALL
No
Sponsors
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Guang'anmen Hospital of China Academy of Chinese Medical Sciences
OTHER
Responsible Party
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Quan Jiang
Director，Devision of Rheumatology
Principal Investigators
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Jiang Quan, Doctor
Role: PRINCIPAL_INVESTIGATOR
Guang'anmen Hospital of China Academy of Chinese Medical Sc
Locations
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Guang'anmen Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Other Identifiers
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PLQ_2016001
Identifier Type: -
Identifier Source: org_study_id