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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03327012
Other study ID # PLQ_2016001
Secondary ID
Status Not yet recruiting
Phase Phase 3
First received October 22, 2017
Last updated October 25, 2017
Start date November 1, 2017
Est. completion date July 28, 2019

Study information

Verified date October 2017
Source Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Contact Jiang Quan, Doctor
Phone 86-010-88001060
Email doctorjq@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 combination,while the other half will receive a Placebo.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date July 28, 2019
Est. primary completion date March 28, 2019
Accepts healthy volunteers No
Gender All
Age group 40 Years to 75 Years
Eligibility Inclusion Criteria:

1.40-75 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.

3.The severity of the imaging classification of K-L=?; 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:

1. within 3 months prior to the trial, the patients were treated within 1 years.

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
China Guang'anmen Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The change from Baseline to week 4 in Visual Analog Scale (VAS)score VAS scores ranges from 0 to 100, with higher scores indicating heavier pain 0 weeks,2 weeks,4 weeks
Secondary The change from Baseline to week 4 in Western Ontarioand McMaster Universities Osteoarthritis Index (WOMAC)score WOMAC scores ranges from 0 to 96, with higher scores indicating greater disability 0 weeks,2 weeks and 4 weeks
Secondary The change from baseline to week 4 in The Short Form-36 Health Survey (SF-36) scores SF-36 scores ranges from 0 to 100,it shows the extent of physical function restriction with higher scores indicating greater disability 0 weeks,4 weeks
Secondary The number of adverse events The number of adverse events related to treatment. 4 weeks
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