- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07800676
A+HA Premium Oral Hyaluronic Acid Drink Functional Evaluation Trial for Delaying Joint Pain
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Taipei, Tajwan
- Taipei Medical University
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Kontakt:
- YiWen Chien, PhD
- Numer telefonu: +886 2-27361661 #28363
- E-mail: ychien@tmu.edu.tw
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
- Individuals with severe cardiovascular disease, severe cerebrovascular disease, severe rheumatic disease, crystal deposition arthropathy, or cancer.
- 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.
- Use of anti-inflammatory analgesics, corticosteroids, or other medications that may affect the study outcomes within one week before the trial.
- Receipt of intra-articular corticosteroid injections, hyaluronic acid injections, platelet-rich plasma (PRP) therapy, or nerve block treatment within one month before the trial.
- Use of medications or consumption of foods that, in the judgment of a physician or dietitian, may affect the outcome measures.
- Any other condition considered by the physician to make the individual unsuitable for participation in the trial.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Komparator placebo: Placebo
Placebo use contents without active ingredients
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1 drink daily
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Eksperymentalny: A+HA premium oral hyaluronic acid drink
A+HA premium oral hyaluronic acid drink contains hyaluronic acid, glucosamine hydrochloride, and chondroitin
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1 drink daily
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Points change of pain evaluation scale
Ramy czasowe: 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
|
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Points change of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Ramy czasowe: 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
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Concentration change of aspartate aminotransferase (AST)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- N202606002
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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