Efficacy and Safety of Tabetri on Osteoarthritis

Jaseng Medical Foundation

Status: Completed

Conditions: Osteoarthritis

Treatments: Dietary Supplement: Placebo capsule; Dietary Supplement: Tabetri capsule

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03757611

JS-CT-2017-02

Details and patient eligibility

About

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.

Full 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, Haeundae, Daejeon, and Bucheon).

Enrollment: 100 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

100 participants in 2 patient groups, including a placebo group

tabetri

Experimental group

Description:

Tabetri capsule will be administered orally twice daily for 12 weeks

Treatment:

Dietary Supplement: Tabetri capsule

Placebo

Placebo Comparator group

Description:

Placebo capsule will be administered orally twice daily for 12 weeks

Treatment:

Dietary Supplement: Placebo capsule