Effects of Black Cumin and Turmeric Along With Quantum Acoustic Waves on Inflammatory Markers and Pain in Osteoarthritis.
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2024
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2024
CompletedFirst Posted
Study publicly available on registry
May 8, 2024
CompletedStudy Start
First participant enrolled
June 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 15, 2025
CompletedJune 3, 2024
May 1, 2024
7 months
May 5, 2024
May 31, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Inflammatory Markers
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.
Baseline (0-week) and 12th week
Secondary Outcomes (2)
Pain
Baseline (0-week), 4-week, 8-week & 12-week.
Knee Injury and Osteoarthritis Outcome Score
Baseline (0-week), 4-week, 8-week & 12-week.
Study Arms (3)
Group A (Black Cumin & Turmeric)
ACTIVE COMPARATORParticipants will receive one capsule of black cumin and turmeric thrice per week (Alternate days) for 12 weeks.
Group B (Black Cumin & Turmeric along with Quantum Acoustic Waves)
ACTIVE COMPARATORParticipants will receive one capsule of black cumin and turmeric along with Quantum Acoustic Waves (QAW) three days per week for 12 weeks
Group C (Quantum Acoustic Waves)
ACTIVE COMPARATORParticipants will receive Quantum Acoustic Waves (QAW) three days per week for 12 weeks
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Infective arthritis.
- Reactive arthritis.
- Major Gastrointestinal or cardiovascular disease/disorder.
- Musculoskeletal injury or disorder that limits participation.
- Patients who are not willing to participate.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Innovative Health Concepts & Research Center
Lahore, Punjab Province, 54700, Pakistan
Related Publications (14)
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.
RESULTSafiri 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.
PMID: 32398285RESULTCui 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.
PMID: 34505846RESULTAbramoff 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.
PMID: 32035570RESULTHu 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.
PMID: 33731688RESULTvan 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.
PMID: 33242602RESULTGeyer M, Schonfeld C. Novel Insights into the Pathogenesis of Osteoarthritis. Curr Rheumatol Rev. 2018;14(2):98-107. doi: 10.2174/1573397113666170807122312.
PMID: 28782470RESULTKulkarni 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.
PMID: 33453867RESULTGeraghty 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.
PMID: 33981927RESULTJang 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.
PMID: 33807695RESULTCoaccioli 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.
PMID: 36294334RESULTAmin 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.
PMID: 26366755RESULTAltman 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.
RESULTXu 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.
PMID: 33392043RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Muhammad Faheem Afzal, *PhD
PSRD Hospital/IHC&RC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2024
First Posted
May 8, 2024
Study Start
June 15, 2024
Primary Completion
December 31, 2024
Study Completion
January 15, 2025
Last Updated
June 3, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share