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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06404606
Enrollment
30
Registered
2024-05-08
Start date
2024-06-15
Completion date
2025-01-15
Last updated
2024-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

Osteoarthritis, Quantum Acoustic Waves, Black Cumin &Turmeric.

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.

Interventions

COMBINATION_PRODUCTBlack cumin and turmeric with Quantum Acoustic Waves (QAW)

Black cumin and turmeric are known to be helpful in reduction of inflammation of human body so it will be used in combination with Quantum Acoustic Waves (QAW) to determine effects on initial degenerative changes in osteoarthritis.

Sponsors

Innovative Health Concepts and Research Center, Lahore,Pakistan
CollaboratorUNKNOWN
Department of Life Sciences, Univeristy of Management and Technology, Lahore.Pakistan.
CollaboratorUNKNOWN
Pakistan Society for Rehabilitation of Differently Abled Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
45 Years to 60 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Inflammatory MarkersBaseline (0-week) and 12th weekThe 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.

Secondary

MeasureTime frameDescription
PainBaseline (0-week), 4-week, 8-week & 12-week.The Standardized Numeric Pain rating Scale (NPRS) will be used for pain assessment of participants. The patients will instruct to rate its pain from 0 to 10. The score interpreted as no pain (0-level) to highest pain (10) where it is further categorized as mild (1-3), moderate (4-7) and severe (8-10).
Knee Injury and Osteoarthritis Outcome ScoreBaseline (0-week), 4-week, 8-week & 12-week.KOOS questionnaire is self-administered questionnaire that will be used to assess five domains of the participants include pain, symptoms, activities of daily livings, sports and recreational function and knee related quality of life.

Countries

Pakistan

Contacts

Primary ContactMuhammad Faheem Afzal, *PhD
faheem78601@gmail.com+92-333-6966697
Backup ContactAfzal Hussain, FCPS
afzalhussain.ihc@gmail.com+92-333-4210699

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026