About this trial
Evaluate the effect of A+HA premium oral hyaluronic acid drink on relieving knee pain.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 45 to 80 years.
Knee osteoarthritis classified as Ahlbäck stage I or II, or Kellgren-Lawrence grade <3.
A Visual Analogue Scale (VAS) pain score ≤3.
A Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score >2 or a total WOMAC score >12.
Disqualifiers
Pregnant or breastfeeding women.
Individuals with a history of knee joint trauma or surgery.
A body mass index (BMI) ≥ 40 kg/m².
Individuals with a psychiatric disorder.
Trial design
Parallel
Treatments tested in this trial
Placebo
Dietary supplement1 drink daily
A+HA premium oral hyaluronic acid drink
Dietary supplement1 drink daily
Treatment groups
Trial outcomes
Primary outcomes
Points change of pain evaluation scale
Self-assess pain using a visual analog scale (VAS), which is a straight line 10 cm in length, with 0 cm on the left representing no pain and 10 cm on the right representing extreme pain. Explain to the subjects that the pain intensity increases from left to right. Ask the subjects to mark the point on the line that corresponds to their pain level, and then record the distance in centimeters from the 0 cm mark. Record the points that the subjects wrote.
Points change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), a widely used questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, and the total score was 96 points (Minimum: 0 points; Maximum: 96 points). The question content was divided into three parts: Pain (20 points), Stiffness (8 points), and Physical function (68 points). The higher score meant worse knee joint function. Record the points that the subjects got.
Other outcomes
Concentration change of aspartate aminotransferase (AST)
Measured from participants' blood samples for safety monitoring purposes
Concentration change of alanine aminotransferase (ALT)
Measured from participants' blood samples for safety monitoring purposes
Concentration change of blood glucose
Measured from participants' blood samples for safety monitoring purposes
Concentration change of high-density lipoprotein
Measured from participants' blood samples for safety monitoring purposes
Sponsors and contacts
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Taipei Medical University
Lead sponsor
Z-Plus Biotechnology Co., Ltd.
Collaborator
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