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

May 31, 2024 updated by: Pakistan Society for Rehabilitation of Differently Abled Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54700
        • Innovative Health Concepts & Research Center
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group A (Black Cumin & Turmeric)
Participants will receive one capsule of black cumin and turmeric thrice per week (Alternate days) for 12 weeks.
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.
Active Comparator: 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
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.
Active Comparator: Group C (Quantum Acoustic Waves)
Participants will receive Quantum Acoustic Waves (QAW) three days per week for 12 weeks
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory Markers
Time Frame: 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.
Baseline (0-week) and 12th week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee Injury and Osteoarthritis Outcome Score
Time Frame: 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.
Baseline (0-week), 4-week, 8-week & 12-week.
Pain
Time Frame: 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).
Baseline (0-week), 4-week, 8-week & 12-week.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pakistan Society for Rehabilitation of Differently Abled Hospital

Collaborators

Innovative Health Concepts and Research Center, Lahore,Pakistan
Department of Life Sciences, Univeristy of Management and Technology, Lahore.Pakistan.

Investigators

  • Principal Investigator: Muhammad Faheem Afzal, *PhD, PSRD Hospital/IHC&RC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

January 15, 2025

Study Registration Dates

First Submitted

May 5, 2024

First Submitted That Met QC Criteria

May 5, 2024

First Posted (Actual)

May 8, 2024

Study Record Updates

Last Update Posted (Actual)

June 3, 2024

Last Update Submitted That Met QC Criteria

May 31, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IHC&RC-DAH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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