Efficacy and Safety of TongBi Capsule in Patients With Knee Osteoarthritis

NCT03418155 | Unknown Phase 3

• 1 other identifier: BH_2016001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the efficacy and safety of TongBi capsule compared with placebo in the treatment of knee osteoarthritis in adults.Half of participants will receive TongBi capsule 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

  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 TongBi Capsule

EXPERIMENTAL

Drug: Treatment of TongBi Capsule

Treatment of TongBi Placebo

PLACEBO COMPARATOR

Drug: Treatment of TongBi placebo

Interventions

Treatment of TongBi Capsule DRUG

TongBi Capsule:0.31g,3times a day, oral, for 4 weeks.

Also known as: capsule A

Treatment of TongBi Capsule

Treatment of TongBi placebo DRUG

TongBi placebo:0.31g,3times a day, oral, for 4 weeks.

Treatment of TongBi Placebo

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age (including 45 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 intra-articular treatment.
• 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.
• 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 TongBi capsul, excipients or similar ingredients;
• Professional athletes;
• doubt or indeed history of alcohol and drug abuse;
• 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 of China Academy of Chinese Medical Sciences

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

  Guang'anmen Hospital of China Academy of Chinese Medical Sc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiang Quan

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: January 25, 2018
• First Posted: February 1, 2018
• Study Start: February 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: October 1, 2019
• Last Updated: February 1, 2018

Record last verified: 2018-01

Locations

CN (1)