Efficacy and Safety of Tabetri on Osteoarthritis

A 12 Week, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial for the Evaluation of the Efficacy and Safety of Tabetri on Osteoarthritis

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Dietary supplement: Tabetri capsule; Dietary supplement: Placebo capsule

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).

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Haeundae Jaseng Hospital of Korean Medicine
  • Daejeon, Korea, Republic of
    • Daejeon Jaseng Hospital of Korean Medicine
  • Seoul, Korea, Republic of
    • Jaseng Hospital of Korean Medicine
  • Gyeonggi
    • Bucheon, Gyeonggi, Korea, Republic of
      • Bucheon Jaseng Hospital of Korean Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: tabetri; Tabetri capsule will be administered orally twice daily for 12 weeks	Dietary supplement: Tabetri capsule; 1,000 mg/capsule (Taheebo extract 600 mg/day)
PLACEBO_COMPARATOR: Placebo; Placebo capsule will be administered orally twice daily for 12 weeks	Dietary supplement: Placebo capsule; 1,000 mg/capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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."	Change of the week 6 and 12 from baseline
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).	Change of the week 6 and 12 from baseline
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.	Change of the week 6 and 12 from baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 and 12 weeks
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	6 and 12 weeks
ESR (Erythrocyte sedimentation rate)	ESR to measure changes in blood inflammatory marker on 12 weeks after administration in comparison with baseline	Change of the week 12 from baseline
CRP (C-reactive protein)	CRP to measure changes in blood inflammatory marker on 12 weeks after administration in comparison with baseline	Change of the week 12 from baseline

Collaborators and Investigators

• Sponsor: Jaseng Medical Foundation
• Collaborators: Nutribiotech Co., Ltd.; Neonutra

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 31, 2017
• Primary Completion (ACTUAL): March 13, 2018
• Study Completion (ACTUAL): June 15, 2018

Study Registration Dates

• First Submitted: November 27, 2018
• First Submitted That Met QC Criteria: November 27, 2018
• First Posted (ACTUAL): November 29, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 30, 2018
• Last Update Submitted That Met QC Criteria: November 28, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: JS-CT-2017-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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