Efficacy and Safety of Tabetri on Osteoarthritis

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03757611
• Other study ID #: JS-CT-2017-02
• Status: Completed
• Phase: N/A
• Start date: July 31, 2017
• Est. completion date: June 15, 2018

Study information

• Verified date: November 2018
• Source: Jaseng Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 15, 2018
• Est. primary completion date: March 13, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Dietary Supplement:
• Tabetri capsule
1,000 mg/capsule (Taheebo extract 600 mg/day)
• Placebo capsule
1,000 mg/capsule

Locations

Country	Name	City	State
Korea, Republic of	Bucheon Jaseng Hospital of Korean Medicine	Bucheon	Gyeonggi
Korea, Republic of	Haeundae Jaseng Hospital of Korean Medicine	Busan
Korea, Republic of	Daejeon Jaseng Hospital of Korean Medicine	Daejeon
Korea, Republic of	Jaseng Hospital of Korean Medicine	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Jaseng Medical Foundation	Neonutra, Nutribiotech Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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