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Efficacy and Safety of Tabetri on Osteoarthritis

NCT ID: NCT03757611

Last Updated: 2018-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-31

Study Completion Date

2018-06-15

Brief Summary

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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

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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).

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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tabetri

Tabetri capsule will be administered orally twice daily for 12 weeks

Group Type EXPERIMENTAL

Tabetri capsule

Intervention Type DIETARY_SUPPLEMENT

1,000 mg/capsule (Taheebo extract 600 mg/day)

Placebo

Placebo capsule will be administered orally twice daily for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo capsule

Intervention Type DIETARY_SUPPLEMENT

1,000 mg/capsule

Interventions

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Tabetri capsule

1,000 mg/capsule (Taheebo extract 600 mg/day)

Intervention Type DIETARY_SUPPLEMENT

Placebo capsule

1,000 mg/capsule

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nutribiotech Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Neonutra

INDUSTRY

Sponsor Role collaborator

Jaseng Medical Foundation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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In-Hyuk Ha, KMD, MPH

Role: PRINCIPAL_INVESTIGATOR

Jaseng Medical Foundation

Locations

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Bucheon Jaseng Hospital of Korean Medicine

Bucheon-si, Gyeonggi-do, South Korea

Site Status

Haeundae Jaseng Hospital of Korean Medicine

Busan, , South Korea

Site Status

Daejeon Jaseng Hospital of Korean Medicine

Daejeon, , South Korea

Site Status

Jaseng Hospital of Korean Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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JS-CT-2017-02

Identifier Type: -

Identifier Source: org_study_id