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

2026年8月30日 更新者:Taipei Medical University
Evaluate the effect of A+HA premium oral hyaluronic acid drink on relieving knee pain.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Taipei、台湾
        • Taipei Medical University
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
安慰剂比较:Placebo
Placebo use contents without active ingredients
1 drink daily
实验性的:A+HA premium oral hyaluronic acid drink
A+HA premium oral hyaluronic acid drink contains hyaluronic acid, glucosamine hydrochloride, and chondroitin
1 drink daily

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Points change of pain evaluation scale
大体时间: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)
大体时间: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

其他结果措施

结果测量
措施说明
大体时间
Concentration change of aspartate aminotransferase (AST)
大体时间: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)
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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)
大体时间: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)
大体时间: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
大体时间: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
大体时间: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
大体时间: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)
大体时间: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
大体时间: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)
大体时间: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
大体时间: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
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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
大体时间: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
大体时间: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
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2027年1月31日

研究完成 (估计的)

2027年2月28日

研究注册日期

首次提交

2026年8月12日

首先提交符合 QC 标准的

2026年8月30日

首次发布 (实际的)

2026年9月2日

研究记录更新

最后更新发布 (实际的)

2026年9月2日

上次提交的符合 QC 标准的更新

2026年8月30日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • N202606002

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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