Efficacy and Safety of Tabetri on Osteoarthritis
Primary Purpose
Osteoarthritis
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tabetri capsule
Placebo capsule
Sponsored by
About this trial
This is an interventional supportive care trial for Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Male or female 40 ~ 75 years of age
- VAS (Visual Analogue Scale) over 30mm
- Kellgren & Lawrence Grade I~II by X-ray
- Subject who agrees to participate in this clinical trial by themselves and signs the Informed Consent Form (ICF)
Exclusion Criteria:
- Subjects who diagnosed inflammatory arthritis (rheumatoid arthritis, fibromyalgia, systemic lupus erythematosus, septic arthritis, gout)
- Joint space under 2 mm by X-ray
- Kellgren & Lawrence Grade over III with osteophyte, irregularly-shaped auricular surfaces, or subchondral bone cyst by X-ray
- Subjects who diagnosed cardiovascular disease, immune disease, infectious diseases, tumor diseases
- Subjects having gastrointestinal diseases
- Uncontrolled hypertension patients (Blood pressure ≥ 160/100mmHg)
- Uncontrolled diabetes mellitus patients (fasting glucose level ≥ 180mg/dl)
- Patients with TSH <= 0.1 uIU/mL or >= 10 uIU/mL
- Subjects have attended abnormal values at AST or ALT (3 times excess at upper limit of the normal values)
- Subjects have attended abnormal values at creatinine (2 times excess at upper limit of the normal values)
- Pregnancy, breast-feeding, or subjects who have a plan to pregnancy within 3 months
- Use of osteoarthritis treatment drugs or dietary supplements within 2 weeks prior to screening
- Psychiatric disorder patient (schizophrenia, depressive disorder, drug abuse)
- History of osteoarthritis treatment therapy within 2 weeks prior to screening
- Have participated in another clinical trial within the 3 months prior to screening
- Subjects who have hypersensitivity history about investigational product
- Have difficulty to be participated in this clinical trial by investigator's decision
Sites / Locations
- Bucheon Jaseng Hospital of Korean Medicine
- Haeundae Jaseng Hospital of Korean Medicine
- Daejeon Jaseng Hospital of Korean Medicine
- Jaseng Hospital of Korean Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
tabetri
Placebo
Arm Description
Tabetri capsule will be administered orally twice daily for 12 weeks
Placebo capsule will be administered orally twice daily for 12 weeks
Outcomes
Primary Outcome Measures
VAS (Visual Analogue Scale)
VAS is used to measure changes in joint pain on 6 and 12 weeks after administration in comparison with baseline. It is presented as a 100-mm horizontal line on which the patient's pain intensity is presented by a point between the extremes of "no pain at all" and "worst pain imaginable."
K-WOMAC (Korean-Western Ontario and McMaster Universities)
K-WOMAC is used to measure changes in joint pain and function on 0, 6, and 12 weeks after administration in comparison with baseline. It measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68).
KSF-36 (Korean-Short Form Health Survey 36)
KSF-36 is used to measure changes in physical and mental function on 0, 6, and 12 weeks after administration in comparison with baseline. It is a 36-item self-report measure designed to assess health-related functioning. It contains eight subscales with four pertaining to physical functioning and four pertaining to psychological functioning. Scores on each subscale can range from 0 to 100, with a higher score representing better health-related functioning. Two composite scores are calculated by averaging all of the scores for four subscales pertaining to each of the two general aspects of functioning.
Secondary Outcome Measures
Subject's global impression of change scale
The change in activity limitations, symptoms, emotions and overall quality of life, related to painful condition that is assessed by subject
Level of Quality
Excellent (category 1): substantial overall improvement of symptoms
Good (category 2): overall improvement of symptoms
Neutral (category 3): no change compared with before
Worse (category 4): overall deterioration of symptoms
Very much worse (category 5): substantial overall deterioration of symptoms
Investigator's global impression of change scale
The change in activity limitations, symptoms, emotions and overall quality of life, related to painful condition that is assessed by investigator
Level of Quality
Excellent (category 1): substantial overall improvement of symptoms
Good (category 2): overall improvement of symptoms
Neutral (category 3): no change compared with before
Worse (category 4): overall deterioration of symptoms
Very much worse (category 5): substantial overall deterioration of symptoms
ESR (Erythrocyte sedimentation rate)
ESR to measure changes in blood inflammatory marker on 12 weeks after administration in comparison with baseline
CRP (C-reactive protein)
CRP to measure changes in blood inflammatory marker on 12 weeks after administration in comparison with baseline
Full Information
NCT ID
NCT03757611
First Posted
November 27, 2018
Last Updated
November 28, 2018
Sponsor
Jaseng Medical Foundation
Collaborators
Nutribiotech Co., Ltd., Neonutra
1. Study Identification
Unique Protocol Identification Number
NCT03757611
Brief Title
Efficacy and Safety of Tabetri on Osteoarthritis
Official Title
A 12 Week, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial for the Evaluation of the Efficacy and Safety of Tabetri on Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
July 31, 2017 (Actual)
Primary Completion Date
March 13, 2018 (Actual)
Study Completion Date
June 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jaseng Medical Foundation
Collaborators
Nutribiotech Co., Ltd., Neonutra
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is a 12-week, multicenter, randomized, double-blind, placebo-controlled clinical trial in order to evaluate the efficacy and safety of tabetri on osteoarthritis.
Detailed Description
This study is prospectively conducted to investigate the efficacy and safety of tabetri in patients diagnosed with osteoarthritis at 4 locations of Jaseng Hospital of Korean Medicine (Gangnam, Haeundae, Daejeon, and Bucheon).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tabetri
Arm Type
Experimental
Arm Description
Tabetri capsule will be administered orally twice daily for 12 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsule will be administered orally twice daily for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Tabetri capsule
Intervention Description
1,000 mg/capsule (Taheebo extract 600 mg/day)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo capsule
Intervention Description
1,000 mg/capsule
Primary Outcome Measure Information:
Title
VAS (Visual Analogue Scale)
Description
VAS is used to measure changes in joint pain on 6 and 12 weeks after administration in comparison with baseline. It is presented as a 100-mm horizontal line on which the patient's pain intensity is presented by a point between the extremes of "no pain at all" and "worst pain imaginable."
Time Frame
Change of the week 6 and 12 from baseline
Title
K-WOMAC (Korean-Western Ontario and McMaster Universities)
Description
K-WOMAC is used to measure changes in joint pain and function on 0, 6, and 12 weeks after administration in comparison with baseline. It measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68).
Time Frame
Change of the week 6 and 12 from baseline
Title
KSF-36 (Korean-Short Form Health Survey 36)
Description
KSF-36 is used to measure changes in physical and mental function on 0, 6, and 12 weeks after administration in comparison with baseline. It is a 36-item self-report measure designed to assess health-related functioning. It contains eight subscales with four pertaining to physical functioning and four pertaining to psychological functioning. Scores on each subscale can range from 0 to 100, with a higher score representing better health-related functioning. Two composite scores are calculated by averaging all of the scores for four subscales pertaining to each of the two general aspects of functioning.
Time Frame
Change of the week 6 and 12 from baseline
Secondary Outcome Measure Information:
Title
Subject's global impression of change scale
Description
The change in activity limitations, symptoms, emotions and overall quality of life, related to painful condition that is assessed by subject
Level of Quality
Excellent (category 1): substantial overall improvement of symptoms
Good (category 2): overall improvement of symptoms
Neutral (category 3): no change compared with before
Worse (category 4): overall deterioration of symptoms
Very much worse (category 5): substantial overall deterioration of symptoms
Time Frame
6 and 12 weeks
Title
Investigator's global impression of change scale
Description
The change in activity limitations, symptoms, emotions and overall quality of life, related to painful condition that is assessed by investigator
Level of Quality
Excellent (category 1): substantial overall improvement of symptoms
Good (category 2): overall improvement of symptoms
Neutral (category 3): no change compared with before
Worse (category 4): overall deterioration of symptoms
Very much worse (category 5): substantial overall deterioration of symptoms
Time Frame
6 and 12 weeks
Title
ESR (Erythrocyte sedimentation rate)
Description
ESR to measure changes in blood inflammatory marker on 12 weeks after administration in comparison with baseline
Time Frame
Change of the week 12 from baseline
Title
CRP (C-reactive protein)
Description
CRP to measure changes in blood inflammatory marker on 12 weeks after administration in comparison with baseline
Time Frame
Change of the week 12 from baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female 40 ~ 75 years of age
VAS (Visual Analogue Scale) over 30mm
Kellgren & Lawrence Grade I~II by X-ray
Subject who agrees to participate in this clinical trial by themselves and signs the Informed Consent Form (ICF)
Exclusion Criteria:
Subjects who diagnosed inflammatory arthritis (rheumatoid arthritis, fibromyalgia, systemic lupus erythematosus, septic arthritis, gout)
Joint space under 2 mm by X-ray
Kellgren & Lawrence Grade over III with osteophyte, irregularly-shaped auricular surfaces, or subchondral bone cyst by X-ray
Subjects who diagnosed cardiovascular disease, immune disease, infectious diseases, tumor diseases
Subjects having gastrointestinal diseases
Uncontrolled hypertension patients (Blood pressure ≥ 160/100mmHg)
Uncontrolled diabetes mellitus patients (fasting glucose level ≥ 180mg/dl)
Patients with TSH <= 0.1 uIU/mL or >= 10 uIU/mL
Subjects have attended abnormal values at AST or ALT (3 times excess at upper limit of the normal values)
Subjects have attended abnormal values at creatinine (2 times excess at upper limit of the normal values)
Pregnancy, breast-feeding, or subjects who have a plan to pregnancy within 3 months
Use of osteoarthritis treatment drugs or dietary supplements within 2 weeks prior to screening
Psychiatric disorder patient (schizophrenia, depressive disorder, drug abuse)
History of osteoarthritis treatment therapy within 2 weeks prior to screening
Have participated in another clinical trial within the 3 months prior to screening
Subjects who have hypersensitivity history about investigational product
Have difficulty to be participated in this clinical trial by investigator's decision
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
In-Hyuk Ha, KMD, MPH
Organizational Affiliation
Jaseng Medical Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bucheon Jaseng Hospital of Korean Medicine
City
Bucheon
State/Province
Gyeonggi
Country
Korea, Republic of
Facility Name
Haeundae Jaseng Hospital of Korean Medicine
City
Busan
Country
Korea, Republic of
Facility Name
Daejeon Jaseng Hospital of Korean Medicine
City
Daejeon
Country
Korea, Republic of
Facility Name
Jaseng Hospital of Korean Medicine
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Efficacy and Safety of Tabetri on Osteoarthritis
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