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

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06404606
• Other study ID #: IHC&RC-DAH
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2024
• Est. completion date: January 15, 2025

Study information

• Verified date: May 2024
• Source: Pakistan Society for Rehabilitation of Differently Abled Hospital
• Contact: Muhammad Faheem Afzal, *PhD
• Phone: +92-333-6966697
• Email: faheem78601[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: January 15, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Combination Product:
• 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.

Locations

Country	Name	City	State
Pakistan	Innovative Health Concepts & Research Center	Lahore	Punjab

Sponsors (3)

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

Country where clinical trial is conducted

Pakistan, 

References & Publications (14)

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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.

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 — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain	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).	Baseline (0-week), 4-week, 8-week & 12-week.
Secondary	Knee Injury and Osteoarthritis Outcome Score	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.	Baseline (0-week), 4-week, 8-week & 12-week.