Efficacy and Safety of TongBi Capsule in Patients With Knee Osteoarthritis

Efficacy and Safety of TongBi Capsule in Patients With Knee Osteoarthritis:a Randomized, Double-blind, Placebo-controlled Post - Market Clinical Study

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.

Study Overview

• Status: Unknown
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Drug: Treatment of TongBi Capsule; Drug: Treatment of TongBi placebo

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jiang Quan; Phone Number: 86-010-88001060; Email: doctorjq@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100052
      • Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment of TongBi Capsule	Drug: Treatment of TongBi Capsule; TongBi Capsule:0.31g,3times a day, oral, for 4 weeks.; Other Names: capsule A
Placebo Comparator: Treatment of TongBi Placebo	Drug: Treatment of TongBi placebo; TongBi placebo:0.31g,3times a day, oral, for 4 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of adverse events	The number of adverse events related to treatment.	4 weeks
The change from Baseline to week 4 in Western Ontarioand McMaster Universities	WOMAC scores ranges from 0 to 96, with higher scores indicating greater disability	0 weeks,2 weeks and 4 weeks
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	0 weeks,4 weeks

Collaborators and Investigators

• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Investigators: Principal Investigator: Jiang Quan, Guang'anmen Hospital of China Academy of Chinese Medical Sc

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2018
• Primary Completion (Anticipated): April 1, 2019
• Study Completion (Anticipated): October 1, 2019

Study Registration Dates

• First Submitted: January 25, 2018
• First Submitted That Met QC Criteria: January 25, 2018
• First Posted (Actual): February 1, 2018

Study Record Updates

• Last Update Posted (Actual): February 1, 2018
• Last Update Submitted That Met QC Criteria: January 25, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: BH_2016001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No