Clinical trial NCT06404606: Effects of Black Cumin and Turmeric Along With Quantum Acoustic Waves on Inflammatory Markers and Pain in Osteoarthritis.
Official title: Effects of Black Cumin and Turmeric Along With Quantum Acoustic Waves on Inflammatory Markers and Pain in Osteoarthritis.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Osteoarthritis
Keywords: Osteoarthritis
Quantum Acoustic Waves
Black Cumin &Turmeric.
Lead sponsor: Pakistan Society for Rehabilitation of Differently Abled Hospital
Sponsor class: OTHER
Collaborators: name: Innovative Health Concepts and Research Center, Lahore,Pakistan
name: Department of Life Sciences, Univeristy of Management and Technology, Lahore.Pakistan.
First posted: 2024-05-08
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Both genders age between 45 to 60 years.
* Rheumatoid Arthritis (RA) negative.
* C-reactive protein (CRP)negative.
* Erythrocyte Sedimentation Rate (ESR) below 30.
* 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/m2.
* Vitamin D above 30 ng/dl.

Exclusion Criteria:

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

Primary outcomes:
measure: Inflammatory Markers
timeFrame: Baseline (0-week) and 12th week
Secondary outcomes:
measure: Pain
timeFrame: Baseline (0-week), 4-week, 8-week & 12-week.
measure: Knee Injury and Osteoarthritis Outcome Score
timeFrame: Baseline (0-week), 4-week, 8-week & 12-week.
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Innovative Health Concepts & Research Center
state: Punjab
Study officials:
affiliation: PSRD Hospital/IHC&RC
name: Muhammad Faheem Afzal, *PhD
role: PRINCIPAL_INVESTIGATOR
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