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 Hospital

Status: Not yet enrolling

Conditions: Osteoarthritis

Treatments: Combination Product: Black cumin and turmeric with Quantum Acoustic Waves (QAW)

Study type: Interventional

Funder types: Other

Identifiers

NCT06404606

IHC&RC-DAH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 45 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

30 participants in 3 patient groups

Group A (Black Cumin & Turmeric)

Active Comparator group

Description:

Participants will receive one capsule of black cumin and turmeric thrice per week (Alternate days) for 12 weeks.

Treatment:

Combination Product: Black cumin and turmeric with Quantum Acoustic Waves (QAW)

Group B (Black Cumin & Turmeric along with Quantum Acoustic Waves)

Active Comparator group

Description:

Participants will receive one capsule of black cumin and turmeric along with Quantum Acoustic Waves (QAW) three days per week for 12 weeks

Treatment:

Combination Product: Black cumin and turmeric with Quantum Acoustic Waves (QAW)

Group C (Quantum Acoustic Waves)

Active Comparator group

Description:

Participants will receive Quantum Acoustic Waves (QAW) three days per week for 12 weeks

Treatment:

Combination Product: Black cumin and turmeric with Quantum Acoustic Waves (QAW)