Efficacy and Safety of Panlongqi Tablet in Patients With Knee Osteoarthritis

NCT03327012 | Unknown Phase 3 DMC

• 1 other identifier: PLQ_2016001
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The change from Baseline to week 4 in Western Ontarioand McMaster Universities Osteoarthritis Index (WOMAC)score

  0 weeks,2 weeks and 4 weeks

• The change from baseline to week 4 in The Short Form-36 Health Survey (SF-36) scores

  0 weeks,4 weeks

• The number of adverse events

  4 weeks

Study Arms (2)

Treatment of Panlongqi Tablet

EXPERIMENTAL

Patients were treated with Panlongqi Tablet.

Drug: Treatment of Panlongqi Tablet

Treatment of Panlongqi Placebo

PLACEBO COMPARATOR

Patients were treated with Panlongqi Placebo Tablet.

Drug: Treatment of Panlongqi placebo

Interventions

Treatment of Panlongqi Tablet DRUG

Panlongqi Tablet:1.2g,3times a day, oral, for 4 weeks.

Also known as: capsule A

Treatment of Panlongqi Tablet

Treatment of Panlongqi placebo DRUG

Panlongqi placebo:1.2g,3times a day, oral, for 4 weeks.

Also known as: capsule B

Treatment of Panlongqi Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age (including 40 years and 75 years old), men and women are not limited.
• \. 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).
• \. informed consent form signed by the patient or legal representative.

You may not qualify if:

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

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead

Study Sites (1)

Guang'anmen Hospital

Beijing, Beijing Municipality, 100052, China

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Jiang Quan, Doctor

  Guang'anmen Hospital of China Academy of Chinese Medical Sc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiang Quan, Doctor

CONTACT

86-010-88001060; doctorjq@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director，Devision of Rheumatology

Study Record Dates

• First Submitted: October 22, 2017
• First Posted: October 31, 2017
• Study Start: November 1, 2017
• Primary Completion: March 28, 2019
• Study Completion: July 28, 2019
• Last Updated: October 31, 2017

Record last verified: 2017-10

Locations

CN (1)