A+HA Premium Oral Hyaluronic Acid Drink Functional Evaluation Trial for Delaying Joint Pain

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-80
SponsorTaipei Medical University

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Placebo

    Dietary supplement

    1 drink daily

  • A+HA premium oral hyaluronic acid drink

    Dietary supplement

    1 drink daily

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: A+HA premium oral hyaluronic acid drinkExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From the start to the end of treatment at 12 weeks
2

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.

Time frame
From the start to the end of treatment at 12 weeks

Secondary outcomes

Other outcomes

1

Concentration change of aspartate aminotransferase (AST)

Measured from participants' blood samples for safety monitoring purposes

Time frame
From the start to the end of treatment at 12 weeks
2

Concentration change of alanine aminotransferase (ALT)

Measured from participants' blood samples for safety monitoring purposes

Time frame
From the start to the end of treatment at 12 weeks
3

Concentration change of blood glucose

Measured from participants' blood samples for safety monitoring purposes

Time frame
From the start to the end of treatment at 12 weeks
4

Concentration change of high-density lipoprotein

Measured from participants' blood samples for safety monitoring purposes

Time frame
From the start to the end of treatment at 12 weeks

Sponsors and contacts

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Taipei Medical University

Lead sponsor

Z-Plus Biotechnology Co., Ltd.

Collaborator

This trial is not recruiting at the moment. You can still explore other options: