Status:
COMPLETED
Efficacy and Safety of Tabetri on Osteoarthritis
Lead Sponsor:
Jaseng Medical Foundation
Collaborating Sponsors:
Nutribiotech Co., Ltd.
Neonutra
Conditions:
Osteoarthritis
Eligibility:
All Genders
40-75 years
Phase:
NA
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.
Detailed 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, Haeunda...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 31 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2018
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03757611
Start Date
July 31 2017
End Date
June 15 2018
Last Update
November 30 2018
Active Locations (4)
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1
Bucheon Jaseng Hospital of Korean Medicine
Bucheon-si, Gyeonggi-do, South Korea
2
Haeundae Jaseng Hospital of Korean Medicine
Busan, South Korea
3
Daejeon Jaseng Hospital of Korean Medicine
Daejeon, South Korea
4
Jaseng Hospital of Korean Medicine
Seoul, South Korea