Back to resultsEfficacy and Safety of TongBi Capsule in Patients With Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Treatment of TongBi Capsule
Treatment of TongBi placebo
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
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:
- within 3 months prior to the trial, the patients were treated within intra-articular treatment.
- 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.
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.
Sites / Locations
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment of TongBi Capsule
Treatment of TongBi Placebo
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
The number of adverse events
The number of adverse events related to treatment.
Full Information
NCT ID
NCT03418155
First Posted
January 25, 2018
Last Updated
January 25, 2018
Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03418155
Brief Title
Efficacy and Safety of TongBi Capsule in Patients With Knee Osteoarthritis
Official Title
Efficacy and Safety of TongBi Capsule in Patients With Knee Osteoarthritis:a Randomized, Double-blind, Placebo-controlled Post - Market Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2018 (Anticipated)
Primary Completion Date
April 1, 2019 (Anticipated)
Study Completion Date
October 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment of TongBi Capsule
Arm Type
Experimental
Arm Title
Treatment of TongBi Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Treatment of TongBi Capsule
Other Intervention Name(s)
capsule A
Intervention Description
TongBi Capsule:0.31g,3times a day, oral, for 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Treatment of TongBi placebo
Intervention Description
TongBi placebo:0.31g,3times a day, oral, for 4 weeks.
Primary Outcome Measure Information:
Title
The change from Baseline to week 4 in Visual Analog Scale (VAS)score
Description
VAS scores ranges from 0 to 100, with higher scores indicating heavier pain
Time Frame
0 weeks,2 weeks，4 weeks
Secondary Outcome Measure Information:
Title
The change from Baseline to week 4 in Western Ontarioand McMaster Universities
Description
WOMAC scores ranges from 0 to 96, with higher scores indicating greater disability
Time Frame
0 weeks,2 weeks and 4 weeks
Title
The change from baseline to week 4 in The Short Form-36 Health Survey (SF-36) scores
Description
SF-36 scores ranges from 0 to 100,it shows the extent of physical function
Time Frame
0 weeks,4 weeks
Title
The number of adverse events
Description
The number of adverse events related to treatment.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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:
within 3 months prior to the trial, the patients were treated within intra-articular treatment.
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.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiang Quan
Phone
86-010-88001060
Email
doctorjq@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiang Quan
Organizational Affiliation
Guang'anmen Hospital of China Academy of Chinese Medical Sc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100052
Country
China
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of TongBi Capsule in Patients With Knee Osteoarthritis
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