Efficacy and Safety of TongBi Capsule in Patients With Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03418155
• Other study ID #: BH_2016001
• Status: Not yet recruiting
• Phase: Phase 3
• First received: January 25, 2018
• Last updated: January 25, 2018
• Start date: February 1, 2018
• Est. completion date: October 1, 2019

Study information

• Verified date: January 2018
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Jiang Quan
• Phone: 86-010-88001060
• Email: doctorjq[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: October 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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=?; 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.

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Treatment of TongBi Capsule
TongBi Capsule:0.31g,3times a day, oral, for 4 weeks.
• Treatment of TongBi placebo
TongBi placebo:0.31g,3times a day, oral, for 4 weeks.

Locations

Country	Name	City	State
China	Guang'anmen Hospital of China Academy of Chinese Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	The number of adverse events	The number of adverse events related to treatment.	4 weeks