Efficacy and Safety of Panlongqi Tablet in Patients With Knee Osteoarthritis

Phase 3

• Conditions: Knee Osteoarthritis
• Interventions: Drug: Treatment of Panlongqi placebo; Drug: Treatment of Panlongqi Tablet

• Registration Number: NCT03327012
• Lead Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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 combination,while the other half will receive a Placebo.

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.

Study Timeline

• Status Verified: 2017-10
• Study First Submitted: 2017-10-22
• Study First Submitted QC: 2017-10-25
• Last Update Submitted: 2017-10-25
• Study First Posted: 2017-10-31
• Last Update Posted: 2017-10-31
• Study Start: 2017-11-01
• Primary Completion: 2019-03-28
• Study Completion: 2019-07-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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≤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

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment of Panlongqi Placebo	Treatment of Panlongqi placebo	Patients were treated with Panlongqi Placebo Tablet.
Treatment of Panlongqi Tablet	Treatment of Panlongqi Tablet	Patients were treated with Panlongqi Tablet.

Primary Outcome Measures

Name	Time	Method
The change from Baseline to week 4 in Visual Analog Scale (VAS)score	0 weeks,2 weeks，4 weeks	VAS scores ranges from 0 to 100, with higher scores indicating heavier pain

Secondary Outcome Measures

Name	Time	Method
The number of adverse events	4 weeks	The number of adverse events related to treatment.
The change from Baseline to week 4 in Western Ontarioand McMaster Universities Osteoarthritis Index (WOMAC)score	0 weeks,2 weeks and 4 weeks	WOMAC scores ranges from 0 to 96, with higher scores indicating greater disability
The change from baseline to week 4 in The Short Form-36 Health Survey (SF-36) scores	0 weeks,4 weeks	SF-36 scores ranges from 0 to 100,it shows the extent of physical function restriction with higher scores indicating greater disability

Trial Locations

Locations (1)

Guang'anmen Hospital; 🇨🇳 Beijing, Beijing, China