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临床试验/NCT06404606
NCT06404606尚未招募不适用

Effects of Black Cumin and Turmeric Along With Quantum Acoustic Waves on Inflammatory Markers and Pain in Osteoarthritis.

Pakistan Society for Rehabilitation of Differently Abled Hospital2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年6月15日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
2
主要终点
Inflammatory Markers

研究概览

简要总结

Osteoarthritis is a chronic inflammatory disease that directly affects the quality of life and financial burden. The understanding of the mechanism and available intervention strategies can not minimize its incidence that increased by 1/10 since 1990. The combination of black cumin and turmeric with sound waves is not well known.

详细描述

Osteoarthritis (OA) is characterized by insult of the joint involving structural and functional modifications including cartilage rupture, bone deterioration and spur formation; presented with pain, inflammation, joint functional limitation. It is estimated that incidence of osteoarthritis is around 20%. Indeed, it is estimated that incidence is higher in Asia and middle east countries (16-29%) as compared to Europe (10-17%) and north America (12-21%). The aggravating symptoms progress and ultimately cause disability, decline quality of life and put economic burden. Various factors involve in the pathophysiology of OA such as mechanical, inflammatory, metabolic, ageing and genetics that causing structural change and functional limitation along with chronic pain. Nevertheless, there are advancement happening about understanding of the basic mechanism of OA. However, low grade inflammation of the synovial lining is currently considered a major contributing factor that play essential role in understanding the pathophysiology; Moreover, adaptive central immunological mechanism is recognized pivotal in tissue inflammation and destruction. The low-grade inflammation and sensitivity of central nervous system progress to be the factor of chronic pain in OA. In particular, the definition of OA now needs to be renewed and considered as multifactor joint disorder that mainly occurs due to metabolic and inflammatory alteration that causes damage of the joints. Therefore, therapeutic interventions suggested for the management of OA are directly influenced by the current understating of OA pathophysiology. So, various inflammatory cytokines increased in OA tissues such as interleukin (IL)-1, IL,6, IL-15, IL-17, IL-18, and Tissue necrotic factor (TNF). It has been proven that black cumin contributes to human body by its anti-inflammatory and anti-nociceptive properties. Moreover, sound waves can stimulate fluid to mobilize through the body and brain and bring oxygen and essential nutrients to the tissue. Similarly, A low-intensity pulsed ultrasound that uses sound waves is considered effective in reduction of inflammation.

As per the researcher's knowledge, there is limited literature available to determine the effect of turmeric and black cumin on inflammation but, there is very little known about the quantum acoustic waves on inflammation, so this study aims to determine the effects of quantum acoustic waves with black cumin and turmeric.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
45 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Both genders age between 45 to 60 years.
  • Rheumatoid Arthritis (RA) negative.
  • C-reactive protein (CRP)negative.
  • Erythrocyte Sedimentation Rate (ESR) below
  • No intake of Anti-inflammatory drugs (NSAIDS, steroids) during the last 02 weeks.
  • Grade 2 and Grade 3 Osteoarthritis as per kellegran criteria.
  • Body Mass Index (BMI) between 18.5 kg/m2 to 29.9 kg/m
  • Vitamin D above 30 ng/dl.

排除标准

  • Infective arthritis.
  • Reactive arthritis.
  • Major Gastrointestinal or cardiovascular disease/disorder.
  • Musculoskeletal injury or disorder that limits participation.
  • Patients who are not willing to participate.

结局指标

主要结局

Inflammatory Markers

时间窗: Baseline (0-week) and 12th week

The blood sample will be taken for assessment of Inflammatory cytokines interleukin (IL)-6, IL,10, IL-17, Tissue necrotic factor (TNF), Complete Blood Count (CBC), CRP, ESR, RA factor, Anti-CCP and Vitamin D for functional parameters.

次要结局

  • Pain(Baseline (0-week), 4-week, 8-week & 12-week.)
  • Knee Injury and Osteoarthritis Outcome Score(Baseline (0-week), 4-week, 8-week & 12-week.)

研究者

发起方
Pakistan Society for Rehabilitation of Differently Abled Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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