Status:
UNKNOWN
Efficacy and Safety of Panlongqi Tablet in Patients With Knee Osteoarthritis
Lead Sponsor:
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
40-75 years
Phase:
PHASE3
Brief Summary
This study evaluates the efficacy and safety of Panlongqi tablet compared with placebo in the treatment of knee osteoarthritis in adults.Half of participants will receive Panlongqi tablet in combinati...
Detailed Description
The test group will be given Panlongqi tablet 1.2g three times per day,the control group will be given placebo 1.2g three times per day. The invention will last 4 weeks.
Eligibility Criteria
Inclusion
- 40-75 years of age (including 40 years and 75 years old), men and women are not limited.
- 2\. western medicine diagnosis of knee osteoarthritis, clinical classification for primary.
- 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
- within 3 months prior to the trial, the patients were treated within 1 years.
- 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.
- Swelling of the knee joint.
- 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.
- 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;
- patients who are unable to cooperate or cooperate with other mental disorders.
- 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.
- allergic constitution or allergic to test seven tablets, excipients or similar ingredients;
- doubt or indeed history of alcohol and drug abuse;
- pregnant or lactating women or recent planned pregnancies and those who are reluctant to use contraceptives;
- participants who participated in other clinical trials within the first 3 months.
- the researchers believe that patients should not participate in this clinical trial.
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 28 2019
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03327012
Start Date
November 1 2017
End Date
July 28 2019
Last Update
October 31 2017
Active Locations (1)
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1
Guang'anmen Hospital
Beijing, Beijing Municipality, China, 100052