Trial | NCT03757611  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    100
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.
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 Started
Jul 31
2017
Primary Completion
Mar 13
2018
Study Completion
Jun 15
2018
Last Update
Nov 30
2018

Dietary Supplement Tabetri capsule

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

Dietary Supplement Placebo capsule

1,000 mg/capsule

tabetri Experimental

Tabetri capsule will be administered orally twice daily for 12 weeks

Placebo Placebo Comparator

Placebo capsule will be administered orally twice daily for 12 weeks

Criteria 

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
No Results Posted