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

NCT ID: NCT06404606

Last Updated: 2024-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-15

Study Completion Date

2025-01-15

Brief Summary

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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

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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.

Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Group A (Black Cumin & Turmeric)

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

Group Type ACTIVE_COMPARATOR

Black cumin and turmeric with Quantum Acoustic Waves (QAW)

Intervention Type COMBINATION_PRODUCT

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.

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

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

Group Type ACTIVE_COMPARATOR

Black cumin and turmeric with Quantum Acoustic Waves (QAW)

Intervention Type COMBINATION_PRODUCT

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.

Group C (Quantum Acoustic Waves)

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

Group Type ACTIVE_COMPARATOR

Black cumin and turmeric with Quantum Acoustic Waves (QAW)

Intervention Type COMBINATION_PRODUCT

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.

Interventions

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Black 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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Innovative Health Concepts and Research Center, Lahore,Pakistan

UNKNOWN

Sponsor Role collaborator

Department of Life Sciences, Univeristy of Management and Technology, Lahore.Pakistan.

UNKNOWN

Sponsor Role collaborator

Pakistan Society for Rehabilitation of Differently Abled Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Muhammad Faheem Afzal, *PhD

Role: PRINCIPAL_INVESTIGATOR

PSRD Hospital/IHC&RC

Locations

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Innovative Health Concepts & Research Center

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Central Contacts

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Muhammad Faheem Afzal, *PhD

Role: CONTACT

+92-333-6966697

Afzal Hussain, FCPS

Role: CONTACT

+92-333-4210699

Facility Contacts

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Muhammad Faheem Afzal, *PhD

Role: primary

+92-333-6966697

Afzal Hussain, FCPS

Role: backup

+92-333-4210699

References

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March L, Cross M, Lo C, Arden NK, Gates L, Leyland K, et al. Osteoarthritis: A Serious Disease: Submitted to the US Food and Drug Administration. 2016.

Reference Type RESULT

Safiri S, Kolahi AA, Smith E, Hill C, Bettampadi D, Mansournia MA, Hoy D, Ashrafi-Asgarabad A, Sepidarkish M, Almasi-Hashiani A, Collins G, Kaufman J, Qorbani M, Moradi-Lakeh M, Woolf AD, Guillemin F, March L, Cross M. Global, regional and national burden of osteoarthritis 1990-2017: a systematic analysis of the Global Burden of Disease Study 2017. Ann Rheum Dis. 2020 Jun;79(6):819-828. doi: 10.1136/annrheumdis-2019-216515. Epub 2020 May 12.

Reference Type RESULT
PMID: 32398285 (View on PubMed)

Cui A, Li H, Wang D, Zhong J, Chen Y, Lu H. Global, regional prevalence, incidence and risk factors of knee osteoarthritis in population-based studies. EClinicalMedicine. 2020 Nov 26;29-30:100587. doi: 10.1016/j.eclinm.2020.100587. eCollection 2020 Dec.

Reference Type RESULT
PMID: 34505846 (View on PubMed)

Abramoff B, Caldera FE. Osteoarthritis: Pathology, Diagnosis, and Treatment Options. Med Clin North Am. 2020 Mar;104(2):293-311. doi: 10.1016/j.mcna.2019.10.007. Epub 2019 Dec 18.

Reference Type RESULT
PMID: 32035570 (View on PubMed)

Hu Y, Chen X, Wang S, Jing Y, Su J. Subchondral bone microenvironment in osteoarthritis and pain. Bone Res. 2021 Mar 17;9(1):20. doi: 10.1038/s41413-021-00147-z.

Reference Type RESULT
PMID: 33731688 (View on PubMed)

van den Bosch MHJ. Osteoarthritis year in review 2020: biology. Osteoarthritis Cartilage. 2021 Feb;29(2):143-150. doi: 10.1016/j.joca.2020.10.006. Epub 2020 Nov 24.

Reference Type RESULT
PMID: 33242602 (View on PubMed)

Geyer M, Schonfeld C. Novel Insights into the Pathogenesis of Osteoarthritis. Curr Rheumatol Rev. 2018;14(2):98-107. doi: 10.2174/1573397113666170807122312.

Reference Type RESULT
PMID: 28782470 (View on PubMed)

Kulkarni P, Martson A, Vidya R, Chitnavis S, Harsulkar A. Pathophysiological landscape of osteoarthritis. Adv Clin Chem. 2021;100:37-90. doi: 10.1016/bs.acc.2020.04.002. Epub 2020 May 29.

Reference Type RESULT
PMID: 33453867 (View on PubMed)

Geraghty T, Winter DR, Miller RJ, Miller RE, Malfait AM. Neuroimmune interactions and osteoarthritis pain: focus on macrophages. Pain Rep. 2021 Mar 9;6(1):e892. doi: 10.1097/PR9.0000000000000892. eCollection 2021.

Reference Type RESULT
PMID: 33981927 (View on PubMed)

Jang S, Lee K, Ju JH. Recent Updates of Diagnosis, Pathophysiology, and Treatment on Osteoarthritis of the Knee. Int J Mol Sci. 2021 Mar 5;22(5):2619. doi: 10.3390/ijms22052619.

Reference Type RESULT
PMID: 33807695 (View on PubMed)

Coaccioli S, Sarzi-Puttini P, Zis P, Rinonapoli G, Varrassi G. Osteoarthritis: New Insight on Its Pathophysiology. J Clin Med. 2022 Oct 12;11(20):6013. doi: 10.3390/jcm11206013.

Reference Type RESULT
PMID: 36294334 (View on PubMed)

Amin B, Hosseinzadeh H. Black Cumin (Nigella sativa) and Its Active Constituent, Thymoquinone: An Overview on the Analgesic and Anti-inflammatory Effects. Planta Med. 2016 Jan;82(1-2):8-16. doi: 10.1055/s-0035-1557838. Epub 2015 Sep 14.

Reference Type RESULT
PMID: 26366755 (View on PubMed)

Altman J. Information processing concerning moving sound sources in the auditory centers and its utilization by brain integrative and motor structures. Auditory pathway: structure and function. 1988:349-54.

Reference Type RESULT

Xu M, Wang L, Wu S, Dong Y, Chen X, Wang S, Li X, Zou C. Review on experimental study and clinical application of low-intensity pulsed ultrasound in inflammation. Quant Imaging Med Surg. 2021 Jan;11(1):443-462. doi: 10.21037/qims-20-680.

Reference Type RESULT
PMID: 33392043 (View on PubMed)

Other Identifiers

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IHC&RC-DAH

Identifier Type: -

Identifier Source: org_study_id

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