Efficacy Test of Curcuminoid Standardized Turmeric Capsules to Improving Inflammatory Biomarkers in Osteoarthritis Genu

Обзор

The goal of this clinical trial is to learn if Curcuminoid Standardized Turmeric Capsules works to treat Osteoarthritis Genu in adults. It will also learn about the safety of Curcuminoid Standardized Turmeric Capsules. The main questions it aims to answer are: * Does Curcuminoid Standardized Turmeric Capsules lower the pain, TNF-Alpha, Interleukin-1 and CRP in the blood? * What medical problems do participants have when taking Curcuminoid Standardized Turmeric Capsules? Researchers will compare Curcuminoid Standardized Turmeric Capsules to a placebo to see if Curcuminoid Standardized Turmeric Capsules works to treat Osteoarthritis Genu. Participants will: * Take Curcuminoid Standardized Turmeric Capsules or a placebo every day for 3 weeks * Visit the clinic once every week for checkups and tests * Keep a diary of their symptoms and the number of times they use a rescue paracetamol

Подробное описание

Evaluate the efficacy, safety, and tolerability of standardized curcuminoid from turmeric extract to TNF-Alpha, Interleukin-1 and CRP in elderly patients with Osteoarthritis Genu. This research is also to evaluate the effect of acupressure and standardized curcuminoid from turmeric extract vs placebo at three weeks : Knee pain as measured by the VAS score. Study design is randomized controlled trial, double-blind to assess efficacy, tolerability, and safety curcuminoid versus placebo. Patients can be pre-screened for specific x-ray and laboratory parameters. Eligible subjects will enter the washout for one week following a screening visit. After the washout period, eligible subjects will be randomized and treated for three weeks. The total duration of the study is up to 5 weeks. The primary efficacy variable is the number of TNF-Alpha, Interleukin-1 and CRP in blood, collected at Week 4 to BL (i.e., change from BL in the number of Leukocytes at Week 4). It will be analyzed using the Wilcoxon signed-rank test or paired t-test and the Mann-Whitney U test or independent t-test. The significance level will be set at 0.05. All outcome measures will be recorded at baseline and after two weeks of intervention

Вмешательства

• Препарат Curcuminoid Standardized Turmeric Capsules
  Samples were made from extracted turmeric and then optimized. The capsule formulation is made from turmeric rhizome extract which contains 30 mg of curcuminoids per capsule. In the study, standardized curcuminoid turmeric extract was given in capsules at 30 mg 3 times a day for 3 weeks
• Другое Placebo
  The capsule formulation is made from maltose which contains 10 mg of curcuminoids per capsule. In the study, the capsule was given in capsules at 30 mg 3 times a day for 3 weeks.

Первичные конечные точки

• Secretion of TNF Alpha [Срок оценки: 3 weeks]
• Secretion of the Interleukin-1 [Срок оценки: 3 weeks]
• Secretion of C Reactive Protein [Срок оценки: 3 weeks]

Вторичные конечные точки (1)

• Change of Pain [Срок оценки: 3 weeks]

Критерии участия

Критерии включения

• Clinical diagnosis of Osteoarthritis which confirmed by physical examination and x-rays
• Experience pain with a Numeric Rating scale of 1-7
• Must be able to swallow capsules
• Must be able to carry out mobility without assistance or with minimal assistance

Критерии исключения

• Parkinson's disease
• Dementia disease
• Psychosis disease
• Fractures
• Joint dislocations
• Cancer
• Rheumatic diseases other than Osteoarthritis (rheumatoid arthritis)
• Undergoing joint replacement therapy.
• Analgesic dependent disease

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Индонезия · 1 центр

• GBI Ngadinegaran — Yogyakarta

Публикации

• Koroljevic ZD, Jordan K, Ivkovic J, Bender DV, Peric P. Curcuma as an anti-inflammatory component in treating osteoarthritis. Rheumatol Int. 2023 Apr;43(4):589-616. doi: 10.1007/s00296-022-05244-8. Epub 2022 Nov 17. PMID 36394597
• Mahanani S, Kertia N, Madyaningrum E. Combination of Curcuminoids and Acupressure for Inflammation and Pain in Older People with Osteoarthritis Genu: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Jun 24;13:e54970. doi: 10.2196/54970. PMID 38771152

Идентификаторы

NCT: NCT07183215 · 055/20/VI/EC/KEPK/STIKES RSBK

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗