The Assessment of TCI633 Probiotics on Pain Relief and Functional Improvement in Osteoarthritis

TCI

Status: Completed

Conditions: Osteoarthritis

Treatments: Dietary Supplement: Placebo; Dietary Supplement: TCI633; Drug: Type 2 collagen

Study type: Interventional

Funder types: Industry

Identifiers

NCT04267432

201703132MSC

Details and patient eligibility

About

To assess TCI633 probiotics on pain relief and functional improvement in osteoarthritis

Full description

This is a double-blind and randomized study. Subjects are informed to consume the samples before meals in the morning every day. The clinical and radiological diagnosis of osteoarthritis of the knee is evaluated by the doctor. The blood samples and questionnaires are collected at every visit of the trial.

Enrollment: 102 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

1. Osteoarthritis patients with joint pain or discomfort (diagnosed by the physician for severe classification of the Kellgren-Lawrence Grade 1-3)
2. Without heart, liver, kidney, endocrine and other major organic diseases (patient return)

Exclusion criteria

1. With heart, liver (GOT and GPT values are 3-fold higher than the standard maximum), kidney (estimated creatinine clearance less than 25 mL/min), endocrine and other major organic diseases (patient return)
2. People with mental illness

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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102 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: Placebo

TCI633

Experimental group

Description:

Testing product

Treatment:

Dietary Supplement: TCI633

Type 2 collagen

Active Comparator group

Description:

Known drug for OA

Treatment:

Drug: Type 2 collagen