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

30 de agosto de 2026 actualizado por: Taipei Medical University
Evaluate the effect of A+HA premium oral hyaluronic acid drink on relieving knee pain.

Descripción general del estudio

Descripción detallada

Arthritis is an inflammation of one or more joints that is characterized by pain, stiffness (especially in the early morning or after exercise), swelling, deformation, and/or reduced mobility. Osteoarthritis, also known as degenerative arthritis, is caused by abnormal damage to the cartilage at the ends of bones. Some patients are caused by injury or congenital abnormalities in the proteins that make up cartilage.

Once the cartilage tissue changes from smooth to rough, or into small pieces. Cartilage is gradually destroyed, and the normally smooth surface becomes irregular. Osteoarthritis usually occurs in joints that require weight load, such as the spine, knees, hips and back, and is usually preceded by some pain and Symptoms of stiffness (mostly stiffness first, then pain), but swelling is not necessarily present. However, a small number of them will cause disability, but once the bones become more fragmented, they are more likely to cause fractures. When osteoarthritis is more severe, the bones can overgrow into osteophytes, known as bone spurs. When bone spurs develop, they can be detected with X-rays, usually in the neck or waist near degenerative cartilage. Formation, these phenomena will not produce any changes in appearance.

Osteoarthritis usually does not occur in adults under the age of 40. Most patients are over the age of 60. Symptoms may be so mild that you are unaware of them until detected by X-ray. The incidence is almost higher in women than in men. three times. Degenerative arthritis is increasing among the elderly in Taiwan. It has become a very important health problem and directly affects the quality of life. Pain control can improve the quality of life.

Previous studies have shown that orally administered hyaluronic acid (HA) can bind to toll-like receptor 4 (TLR-4) on intestinal epithelial cells, thereby increasing the secretion of the anti-inflammatory cytokine IL-10 and suppressor of cytokine signaling 3 (SOCS3), while suppressing the expression of the pro-inflammatory cytokine pleiotrophin, ultimately alleviating osteoarthritis. Regarding the regulation of cartilage degradation-related factors, HA can reduce irregularities on the cartilage surface as well as the loss of cartilage tissue and chondrocytes by suppressing the mRNA expression of MMP-3, MMP-9, and MMP-13 in cartilage tissue. In terms of oxidative stress, HA may also alleviate cartilage damage by downregulating inducible nitric oxide synthase (iNOS), thereby reducing nitric oxide (NO) production, and by inhibiting cyclooxygenase-2 (COX-2) and prostaglandin E2 (PGE2) production. To further enhance its efficacy in improving osteoarthritis, hyaluronic acid was combined with glucosamine and chondroitin. Previous studies have demonstrated that these two ingredients can improve connective tissue function and reduce cartilage matrix degradation. Therefore, the aim of this study was to investigate the effects of A+HA premium oral hyaluronic acid drink on improving knee pain.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

60

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Taipei, Taiwán
        • Taipei Medical University
        • Contacto:
          • YiWen Chien, PhD
          • Número de teléfono: +886 2-27361661 #28363
          • Correo electrónico: ychien@tmu.edu.tw

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  1. Aged 45 to 80 years.
  2. Knee osteoarthritis classified as Ahlbäck stage I or II, or Kellgren-Lawrence grade <3.
  3. A Visual Analogue Scale (VAS) pain score ≤3.
  4. A Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score >2 or a total WOMAC score >12.

Exclusion Criteria:

  1. Pregnant or breastfeeding women.
  2. Individuals with a history of knee joint trauma or surgery.
  3. A body mass index (BMI) ≥ 40 kg/m².
  4. Individuals with a psychiatric disorder.
  5. Individuals with severe cardiovascular disease, severe cerebrovascular disease, severe rheumatic disease, crystal deposition arthropathy, or cancer.
  6. Individuals who use a wheelchair and have a Manual Muscle Testing (MMT) grade ≤3 in the lower extremities, or who require a wheelchair due to physical discomfort.
  7. Use of anti-inflammatory analgesics, corticosteroids, or other medications that may affect the study outcomes within one week before the trial.
  8. Receipt of intra-articular corticosteroid injections, hyaluronic acid injections, platelet-rich plasma (PRP) therapy, or nerve block treatment within one month before the trial.
  9. Use of medications or consumption of foods that, in the judgment of a physician or dietitian, may affect the outcome measures.
  10. Any other condition considered by the physician to make the individual unsuitable for participation in the trial.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: Placebo
Placebo use contents without active ingredients
1 drink daily
Experimental: A+HA premium oral hyaluronic acid drink
A+HA premium oral hyaluronic acid drink contains hyaluronic acid, glucosamine hydrochloride, and chondroitin
1 drink daily

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Points change of pain evaluation scale
Periodo de tiempo: From the start to the end of treatment at 12 weeks
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.
From the start to the end of treatment at 12 weeks
Points change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Periodo de tiempo: From the start to the end of treatment at 12 weeks
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.
From the start to the end of treatment at 12 weeks

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Concentration change of aspartate aminotransferase (AST)
Periodo de tiempo: From the start to the end of treatment at 12 weeks
Measured from participants' blood samples for safety monitoring purposes
From the start to the end of treatment at 12 weeks
Concentration change of alanine aminotransferase (ALT)
Periodo de tiempo: From the start to the end of treatment at 12 weeks
Measured from participants' blood samples for safety monitoring purposes
From the start to the end of treatment at 12 weeks
Concentration change of blood glucose
Periodo de tiempo: From the start to the end of treatment at 12 weeks
Measured from participants' blood samples for safety monitoring purposes
From the start to the end of treatment at 12 weeks
Concentration change of high-density lipoprotein
Periodo de tiempo: From the start to the end of treatment at 12 weeks
Measured from participants' blood samples for safety monitoring purposes
From the start to the end of treatment at 12 weeks
Concentration change of low-density lipoprotein
Periodo de tiempo: From the start to the end of treatment at 12 weeks
Measured from participants' blood samples for safety monitoring purposes
From the start to the end of treatment at 12 weeks
Concentration change of free fatty acid
Periodo de tiempo: From the start to the end of treatment at 12 weeks
Measured from participants' blood samples for safety monitoring purposes
From the start to the end of treatment at 12 weeks
Concentration change of cholesterol
Periodo de tiempo: From the start to the end of the treatment at 12 weeks
Measured from participants' blood samples for safety monitoring purposes
From the start to the end of the treatment at 12 weeks
Concentration change of triglyceride
Periodo de tiempo: From the start to the end of treatment at 12 weeks
Measured from participants' blood samples for safety monitoring purposes
From the start to the end of treatment at 12 weeks
Count change of differential count (DC)
Periodo de tiempo: From the start to the end of treatment at 12 weeks
Measured from participants' blood samples for safety monitoring purposes
From the start to the end of treatment at 12 weeks
Mean corpuscular volume (MCV)
Periodo de tiempo: From the start to the end of treatment at 12 weeks
Measured from participants' blood samples for safety monitoring purposes
From the start to the end of treatment at 12 weeks
Concentration change of hemoglobin
Periodo de tiempo: From the start to the end of treatment at 12 weeks
Measured from participants' blood samples for safety monitoring purposes
From the start to the end of treatment at 12 weeks
Concentration change of hematocrit
Periodo de tiempo: From the start to the end of treatment at 12 weeks
Measured from participants' blood samples for safety monitoring purposes
From the start to the end of treatment at 12 weeks
Red blood cell count
Periodo de tiempo: From the start to the end of treatment at 12 weeks
Measured from participants' blood samples for safety monitoring purposes
From the start to the end of treatment at 12 weeks
Concentration change of gamma-glutamyl transferase (γ-GT)
Periodo de tiempo: From the start to the end of treatment at 12 weeks
Measured from participants' blood samples for safety monitoring purposes
From the start to the end of treatment at 12 weeks
Concentration change of albumin
Periodo de tiempo: From the start to the end of treatment at 12 weeks
Measured from participants' blood samples for safety monitoring purposes
From the start to the end of treatment at 12 weeks
Concentration change of blood urea nitrogen (BUN)
Periodo de tiempo: From the start to the end of treatment at 12 weeks
Measured from participants' blood samples for safety monitoring purposes
From the start to the end of treatment at 12 weeks
Concentration change of creatinine
Periodo de tiempo: From the start to the end of treatment at 12 weeks
Measured from participants' blood samples for safety monitoring purposes
From the start to the end of treatment at 12 weeks
Concentration change of urea acid
Periodo de tiempo: From the start to the end of treatment at 12 weeks
Measured from participants' blood samples for safety monitoring purposes
From the start to the end of treatment at 12 weeks
Concentration change of thyroid-stimulating hormone (TSH)
Periodo de tiempo: From the start to the end of treatment at 12 weeks
Measured from participants' blood samples for safety monitoring purposes
From the start to the end of treatment at 12 weeks
Concentration change of triiodothyronine (T3)
Periodo de tiempo: From the start to the end of treatment at 12 weeks
Measured from participants' blood samples for safety monitoring purposes
From the start to the end of treatment at 12 weeks
Concentration change of thyroxine (T4)
Periodo de tiempo: From the start to the end of treatment at 12 weeks
Measured from participants' blood samples for safety monitoring purposes
From the start to the end of treatment at 12 weeks
Concentration change of sodium (Na)
Periodo de tiempo: From the start to the end of treatment at 12 weeks
Measured from participants' blood samples for safety monitoring purposes
From the start to the end of treatment at 12 weeks
Concentration change of potassium (K)
Periodo de tiempo: From the start to the end of treatment at 12 weeks
Measured from participants' blood samples for safety monitoring purposes
From the start to the end of treatment at 12 weeks
Concentration change of calcium (Ca)
Periodo de tiempo: From the start to the end of treatment at 12 weeks
Measured from participants' blood samples for safety monitoring purposes
From the start to the end of treatment at 12 weeks
Concentration change of magnesium (Mg)
Periodo de tiempo: From the start to the end of treatment at 12 weeks
Measured from participants' blood samples for safety monitoring purposes
From the start to the end of treatment at 12 weeks
Concentration change of phosphorus (P)
Periodo de tiempo: From the start to the end of treatment at 12 weeks
Measured from participants' blood samples for safety monitoring purposes
From the start to the end of treatment at 12 weeks
Change of urine pH value
Periodo de tiempo: From the start to the end of treatment at 12 weeks
Measured from participants' blood samples for safety monitoring purposes
From the start to the end of treatment at 12 weeks
Concentration change of urine protein
Periodo de tiempo: From the start to the end of treatment at 12 weeks
Measured from participants' blood samples for safety monitoring purposes
From the start to the end of treatment at 12 weeks
Concentration change of urine glucose
Periodo de tiempo: From the start to the end of treatment at 12 weeks
Measured from participants' blood samples for safety monitoring purposes
From the start to the end of treatment at 12 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

31 de enero de 2027

Finalización del estudio (Estimado)

28 de febrero de 2027

Fechas de registro del estudio

Enviado por primera vez

12 de agosto de 2026

Primero enviado que cumplió con los criterios de control de calidad

30 de agosto de 2026

Publicado por primera vez (Actual)

2 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

30 de agosto de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • N202606002

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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