Efficacy and Safety of Tabetri on Osteoarthritis

NCT03757611 | Completed

• 1 other identifier: JS-CT-2017-02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

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.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (4)

• Subject's global impression of change scale

  6 and 12 weeks

• Investigator's global impression of change scale

  6 and 12 weeks

• ESR (Erythrocyte sedimentation rate)

  Change of the week 12 from baseline

• CRP (C-reactive protein)

  Change of the week 12 from baseline

Study Arms (2)

tabetri

EXPERIMENTAL

Tabetri capsule will be administered orally twice daily for 12 weeks

Dietary Supplement: Tabetri capsule

Placebo

PLACEBO COMPARATOR

Placebo capsule will be administered orally twice daily for 12 weeks

Dietary Supplement: Placebo capsule

Interventions

Tabetri capsule DIETARY_SUPPLEMENT

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

tabetri

Placebo capsule DIETARY_SUPPLEMENT

1,000 mg/capsule

Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Jaseng Medical Foundation: lead
• Nutribiotech Co., Ltd.: collaborator
• Neonutra: collaborator

Study Sites (4)

Bucheon Jaseng Hospital of Korean Medicine

Bucheon-si, Gyeonggi-do, South Korea

Location

Haeundae Jaseng Hospital of Korean Medicine

Busan, South Korea

Location

Daejeon Jaseng Hospital of Korean Medicine

Daejeon, South Korea

Location

Jaseng Hospital of Korean Medicine

Seoul, South Korea

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• In-Hyuk Ha, KMD, MPH

  Jaseng Medical Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: November 29, 2018
• Study Start: July 31, 2017
• Primary Completion: March 13, 2018
• Study Completion: June 15, 2018
• Last Updated: November 30, 2018

Record last verified: 2018-11

Locations

KR (4)