Efficacy and Safety of TongBi Capsule in Patients With Knee Osteoarthritis

NCT ID: NCT03418155

Last Updated: 2018-02-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2019-10-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment of TongBi Capsule

Group Type: EXPERIMENTAL

Treatment of TongBi Capsule

Intervention Type: DRUG

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

Treatment of TongBi Placebo

Group Type: PLACEBO_COMPARATOR

Treatment of TongBi placebo

Intervention Type: DRUG

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

Interventions

Treatment of TongBi Capsule

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

Intervention Type: DRUG

Treatment of TongBi placebo

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

Intervention Type: DRUG

Other Intervention Names

capsule A

Eligibility Criteria

Inclusion Criteria

1.45-75 years of age (including 45 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 intra-articular treatment.

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. 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.

4. 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.

5. Allergic constitution or allergic to TongBi capsul, excipients or similar ingredients;

6. Professional athletes;

7. doubt or indeed history of alcohol and drug abuse;

8. participants who participated in other clinical trials within the first 3 months;

9. the researchers believe that patients should not participate in this clinical trial.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Quan Jiang

Director，Devision of Rheumatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jiang Quan

Role: PRINCIPAL_INVESTIGATOR

Guang'anmen Hospital of China Academy of Chinese Medical Sc

Locations

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Jiang Quan

Role: CONTACT

doctorjq@126.com

86-010-88001060

Other Identifiers

BH_2016001

Identifier Type: -

Identifier Source: org_study_id