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Completed

NCT Number: NCT03757611

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.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bucheon Jaseng Hospital of Korean Medicine, Bucheon-si, Gyeonggi-do, South Korea

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tabetri capsule

Dietary Supplement

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

placebo capsule

Dietary Supplement

1,000 mg/capsule

Primary outcomes

  1. VAS (Visual Analogue Scale)

    Time frame: Change of the week 6 and 12 from baseline

    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."

  2. K-WOMAC (Korean-Western Ontario and McMaster Universities)

    Time frame: Change of the week 6 and 12 from baseline

    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).

  3. KSF-36 (Korean-Short Form Health Survey 36)

    Time frame: Change of the week 6 and 12 from baseline

    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 outcomes

  1. Subject's global impression of change scale

    Time frame: 6 and 12 weeks

    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

  2. Investigator's global impression of change scale

    Time frame: 6 and 12 weeks

    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

  3. ESR (Erythrocyte sedimentation rate)

    Time frame: Change of the week 12 from baseline

    ESR to measure changes in blood inflammatory marker on 12 weeks after administration in comparison with baseline

  4. CRP (C-reactive protein)

    Time frame: Change of the week 12 from baseline

    CRP to measure changes in blood inflammatory marker on 12 weeks after administration in comparison with baseline

Sponsors and collaborators

Lead sponsor

Jaseng Medical Foundation

Other

Collaborators

  • Neonutra
  • Nutribiotech Co., Ltd.

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 29, 2018
Registry last updated
Nov 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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