OsteoarthritisNCT06404606
Effects of Black Cumin and Turmeric Along With Quantum Acoustic Waves on Inflammatory Markers and Pain in Osteoarthritis.
A study testing Black cumin and turmeric with Quantum Acoustic Waves (QAW) in people with Osteoarthritis, run by Pakistan Society for Rehabilitation of Differently Abled Hospital at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 45 to 60 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Black cumin and turmeric with Quantum Acoustic Waves (QAW)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jun 2024to 15 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Pakistan1 site
Innovative Health Concepts & Research Center
Lahore, Punjab Province, 54700
Muhammad Faheem Afzal, *PhD, +92-333-6966697, faheem78601@gmail.com
Afzal Hussain, FCPS, +92-333-4210699, afzalhussain.ihc@gmail.com
About this study
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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- Black cumin and turmeric with Quantum Acoustic Waves (QAW)
- Keywords
- Osteoarthritis, Quantum Acoustic Waves, Black Cumin &Turmeric.
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Black cumin and turmeric with Quantum Acoustic Waves (QAW)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.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Black Cumin & Turmeric) | Active comparator | Participants will receive one capsule of black cumin and turmeric thrice per week (Alternate days) for 12 weeks. Receives: Combination Product: Black cumin and turmeric with Quantum Acoustic Waves (QAW) |
| Group B (Black Cumin & Turmeric along with Quantum Acoustic Waves) | Active comparator | Participants will receive one capsule of black cumin and turmeric along with Quantum Acoustic Waves (QAW) three days per week for 12 weeks Receives: Combination Product: Black cumin and turmeric with Quantum Acoustic Waves (QAW) |
| Group C (Quantum Acoustic Waves) | Active comparator | Participants will receive Quantum Acoustic Waves (QAW) three days per week for 12 weeks Receives: Combination Product: Black cumin and turmeric with Quantum Acoustic Waves (QAW) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (0-week) and 12th week
Secondary outcomes (2)
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).
Measured: Baseline (0-week), 4-week, 8-week & 12-week.
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.
Measured: Baseline (0-week), 4-week, 8-week & 12-week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start15 Jun 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion15 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Society for Rehabilitation of Differently Abled Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Innovative Health Concepts and Research Center, Lahore,Pakistan, University of Management and Technology Lahore
- Responsible party
- Sponsor
- Investigators
- Muhammad Faheem Afzal, *PhD, Principal investigator, PSRD Hospital/IHC&RC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404606
- Sponsor's protocol ID
- IHC&RC-DAH
- Status last verified
- May 2024
- First submitted
- 5 May 2024
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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 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.
PubMed 32398285Cui 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.
PubMed 34505846Abramoff 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.
PubMed 32035570Hu 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.
PubMed 33731688van 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.
PubMed 33242602Geyer M, Schonfeld C. Novel Insights into the Pathogenesis of Osteoarthritis. Curr Rheumatol Rev. 2018;14(2):98-107. doi: 10.2174/1573397113666170807122312.
PubMed 28782470Kulkarni 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.
PubMed 33453867Geraghty 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.
PubMed 33981927Jang 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.
PubMed 33807695Coaccioli 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.
PubMed 36294334Amin 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.
PubMed 26366755Altman 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.
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.
PubMed 33392043
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Black Cumin and Turmeric Along With Quantum Acoustic Waves on Inflammatory Markers and Pain in Osteoarthritis.
- ClinicalTrials.gov ID
- NCT06404606
- Acronym / sponsor ID
- IHC&RC-DAH
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis, Quantum Acoustic Waves, Black Cumin &Turmeric.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Pakistan Society for Rehabilitation of Differently Abled HospitalUniversity, hospital or other
- Collaborators
- Innovative Health Concepts and Research Center, Lahore,Pakistan, University of Management and Technology Lahore
- Study start
- 15 Jun 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 15 Jan 2025 (estimated)
- First posted
- 8 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A (Black Cumin & Turmeric) | Active comparator | Combination Product: Black cumin and turmeric with Quantum Acoustic Waves (QAW)Participants 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 comparator | Combination Product: Black cumin and turmeric with Quantum Acoustic Waves (QAW)Participants 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 comparator | Combination Product: Black cumin and turmeric with Quantum Acoustic Waves (QAW)Participants will receive Quantum Acoustic Waves (QAW) three days per week for 12 weeks |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- Infective arthritis.
- Reactive arthritis.
- Major Gastrointestinal or cardiovascular disease/disorder.
- Musculoskeletal injury or disorder that limits participation.
- Patients who are not willing to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Combination product | Group A (Black Cumin & Turmeric), Group B (Black Cumin & Turmeric along with Quantum Acoustic Waves), Group C (Quantum Acoustic Waves) |
Primary outcome
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.
2 secondary outcomes
Pain
Time frame: Baseline (0-week), 4-week, 8-week & 12-week.
Knee Injury and Osteoarthritis Outcome Score
Time frame: Baseline (0-week), 4-week, 8-week & 12-week.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Results publicationMarch 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.
- Results publication: PubMed 32398285Safiri 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.
- Results publication: PubMed 34505846Cui 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.
- Results publication: PubMed 32035570Abramoff 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.
- Results publication: PubMed 33731688Hu 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.
- Results publication: PubMed 33242602van 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.
- Results publication: PubMed 28782470Geyer M, Schonfeld C. Novel Insights into the Pathogenesis of Osteoarthritis. Curr Rheumatol Rev. 2018;14(2):98-107. doi: 10.2174/1573397113666170807122312.
- Results publication: PubMed 33453867Kulkarni 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.
- Results publication: PubMed 33981927Geraghty 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.
- Results publication: PubMed 33807695Jang 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.
- Results publication: PubMed 36294334Coaccioli 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.
- Results publication: PubMed 26366755Amin 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.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis
Not yet recruiting
Holistic Healing for Knee Osteoarthritis
Knee Osteoarthritis (Knee OA)
Active, not recruiting
Effectiveness of Therapeutic Exercises on Spinopelvic Mobility
Osteoarthritis (OA) of the Hip
Recruiting
Effect of Anti-inflammatory Diet in Osteoarthritis
Osteoarthritis, Knee
Active, not recruitingPhase 2/3
Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
Osteoarthritis, Knee
Not yet recruiting
The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
Osteoarthritis of the Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Faheem Afzal, *PhD principal investigator
PSRD Hospital/IHC&RC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Black cumin and turmeric with Quantum Acoustic Waves (QAW) in people with Osteoarthritis, run by Pakistan Society for Rehabilitation of Differently Abled Hospital at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Faheem Afzal, *PhD (+92-333-6966697, faheem78601@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory Markers (time frame: Baseline (0-week) and 12th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06404606, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2024.