Effects of Black Cumin and Turmeric Along With Quantum Acoustic Waves on Inflammatory Markers and Pain in Osteoarthritis.
- Conditions
- Osteoarthritis
- Interventions
- Combination Product: Black cumin and turmeric with Quantum Acoustic Waves (QAW)
- Registration Number
- NCT06404606
- Lead Sponsor
- Pakistan Society for Rehabilitation of Differently Abled Hospital
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 30
- 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.
- Infective arthritis.
- Reactive arthritis.
- Major Gastrointestinal or cardiovascular disease/disorder.
- Musculoskeletal injury or disorder that limits participation.
- Patients who are not willing to participate.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A (Black Cumin & Turmeric) Black cumin and turmeric with Quantum Acoustic Waves (QAW) Participants will receive one capsule of black cumin and turmeric thrice per week (Alternate days) for 12 weeks. Group C (Quantum Acoustic Waves) Black cumin and turmeric with Quantum Acoustic Waves (QAW) Participants will receive Quantum Acoustic Waves (QAW) three days per week for 12 weeks Group B (Black Cumin & Turmeric along with Quantum Acoustic Waves) Black cumin and turmeric with Quantum Acoustic Waves (QAW) Participants will receive one capsule of black cumin and turmeric along with Quantum Acoustic Waves (QAW) three days per week for 12 weeks
- Primary Outcome Measures
Name Time Method Inflammatory Markers 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.
- Secondary Outcome Measures
Name Time Method Pain Baseline (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 Score Baseline (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.
Trial Locations
- Locations (1)
Innovative Health Concepts & Research Center
🇵🇰Lahore, Punjab, Pakistan