Knee OsteoarthritisPhase 1/2NCT05579665
Effectiveness of PRP, Conditioned Medium UC-MSCs Secretome and Hyaluronic Acid for the Treatment of Knee Osteoarthritis
A Phase 1/2 study testing Platelet-rich Plasma, Conditioned Medium From Umbilical Cord Mesenchymal Stem Cell Culture (MSCs) Secretome and Low Molecular Weight Hyaluronic Acid in people with Knee Osteoarthritis, run by Universitas Sriwijaya at 1 site in Indonesia.
Trial summary
The clinical trial will be carried out at the Dr. Moh. Hoesin Central Hospital, Palembang and planned from October 2022 to March 2023. This study aims to compare the efficacy of Platelet Rich Plasma, Conditioned Medium From Umbilical Cord Mesenchymal Stem Cell (MSC) Culture Secretome and hyaluronic acid for the… Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Platelet-rich Plasma, Conditioned Medium From Umbilical Cord Mesenchymal Stem Cell Culture (MSCs) Secretome and Low Molecular Weight Hyaluronic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteIndonesia
- Study dates
- 2 Oct 2022to 31 May 2023
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 30-60 years
- Suffering from grade 2 and 3 osteoarthritis (OA) was identified by two observers who differed accordingly the Kellgren and Lawrence research scale
- Patient with knee pain that had been continuing for at least 12 months with no relief using anti-inflammatory medications and that deteriorated with weight-bearing
- Patients can understand the nature of the study and written informed consent is given to patients
Who cannot join
- Age > 60 years
- Acute Knee Osteoarthritis Effusions
- Patients are not willing to obey the study protocol
- There are signs of infection local or general infection or positive serology for HIV, hepatitis and syphilis
- There is a congenital disease that causes significant deformity of the knee can interfere with cell applications and interpret results
- Articular injection of the knee by any drug during the previous 3 months
- Participate in any clinical trial or treatment 30 days before the study
- Other conditions may, according to medical criteria, not support participation in this research (The recent history of knee trauma, Autoimmune rheumatic diseases, Uncontrolled systemic diseases such as diabetes or hypertension, patient with Immunosuppressive or anticoagulant treatment and cancer)
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Mohammad Hoesin Central General HospitalPalembang
Palembang, South Sumatera, 30114
About this study
Official title: Comparative Effectiveness of Platelet Rich Plasma (PRP), Conditioned Medium From Umbilical Cord Mesenchymal Stem Cell Culture (MSCs) Secretome and Hyaluronic Acid (HA) for the Treatment of Knee Osteoarthritis
The clinical trial will be carried out at the Dr. Moh. Hoesin Central Hospital, Palembang and planned from October 2022 to March 2023.
This study aims to compare the efficacy of Platelet Rich Plasma, Conditioned Medium From Umbilical Cord Mesenchymal Stem Cell (MSC) Culture Secretome and hyaluronic acid for the Treatment of Knee Osteoarthritis
Read the detailed description
In this, prospective, Open-label study, patients with mild to moderate symptomatic knee osteoarthritis will be randomized to receive either a series of platelet-rich plasma or hyaluronic acid or Conditioned Medium From Umbilical Cord Mesenchymal Stem Cell (MSC) Culture Secretome injections under ultrasound guidance. Each of the groups were given 5 times injection 3 cc platelet-rich plasma or 2 cc hyaluronic acid or 2cc Conditioned Medium From Umbilical Cord MSC Secretome at intervals 1 weeks.
Clinical data in the form of subjective outcome measures will be collected pre-treatment and 6 months after injection.
- Conditions
- Knee Osteoarthritis
- Being tested
- Platelet-rich Plasma, Conditioned Medium From Umbilical Cord Mesenchymal Stem Cell Culture (MSCs) Secretome, Low Molecular Weight Hyaluronic Acid
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-rich PlasmaBiological
Also called PRP
Research participants own blood will be used to prepare the platelet rich plasma injectate.
Conditioned Medium From Umbilical Cord Mesenchymal Stem Cell Culture (MSCs) SecretomeBiological
Also called Conditioned Medium UC-MSCs Secretome
Conditioned Medium UC-MSCs Secretome which will be injected into the affected knee using ultrasound guidance.
Low Molecular Weight Hyaluronic AcidDrug
Also called HA
low molecular weight hyaluronic acid which will be injected into the affected knee using ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| Platelet-rich Plasma (PRP) | Experimental | Platelet-rich plasma administered 5 times as an intra-articular injection under ultrasound guidance as a series of one weekly injections to the affected knee. 1 weekly injections are of leukocyte poor, buffer/additive free, singe spin, platelet-rich plasma averaging 3mL in volume. Receives: Biological: Platelet-rich Plasma |
| Conditioned Medium From Umbilical Cord Mesenchymal Stem Cell Culture (MSCs) Secretome | Experimental | Conditioned Medium From Umbilical Cord Mesenchymal Stem Cell Culture (MSCs) Secretome administered 5 times as an intra-articular injection under ultrasound guidance as a series of one weekly injections to the affected knee. 1 weekly injections are Conditioned Medium From Umbilical Cord Mesenchymal Stem Cell Culture (MSCs) Secretome averaging 2 mL in volume. Receives: Biological: Conditioned Medium From Umbilical Cord Mesenchymal Stem Cell Culture (MSCs) Secretome |
| Hyaluronic Acid (HA) | Experimental | Hyaluronic Acid administered 5 times as an intra-articular injection under ultrasound guidance as a series of one weekly injections to the affected knee. 1 weekly injections are of low molecular weight hyaluronan in a 2mL injection. Receives: Drug: Low Molecular Weight Hyaluronic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
To asses pain score, score 1(good)-10(worst)
Measured: Pre-Treatment
Visual Analog Scale (VAS)
To asses pain score, score 1(good)-10(worst)
Measured: 3 months after the fifth once-weekly injection.
Visual Analog Scale (VAS)
To asses pain score, score 1(good)-10(worst)
Measured: 6 months after the fifth once-weekly injection.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
To evaluate the condition of patients with osteoarthritis, including pain, stiffness, and physical functioning of the joints. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a self-administered questionnaire consisting of 24 items divided into three subscales: pain (0-20), stiffness (0-8), and physical function (0-68).
Each item is scored on a Likert scale, and subscale scores are summed to obtain a total WOMAC score ranging from 0 to 96.
Higher scores indicate worse pain, stiffness, and functional limitation.
Measured: Pre-Treatment
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
To evaluate the condition of patients with osteoarthritis, including pain, stiffness, and physical functioning of the joints. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a self-administered questionnaire consisting of 24 items divided into three subscales: pain (score range 0-20), stiffness (0-8), and physical function (0-68).
Each item is scored on a Likert scale (0-4), and subscale scores are summed to obtain a total WOMAC score ranging from 0 to 96.
Higher scores indicate worse pain, stiffness, and functional limitation.
Measured: 3 months after the fifth once-weekly injection
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
To evaluate the condition of patients with osteoarthritis, including pain, stiffness, and physical functioning of the joints. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a self-administered questionnaire consisting of 24 items divided into three subscales: pain (score range 0-20), stiffness (0-8), and physical function (0-68).
Each item is scored on a Likert scale (0-4), and subscale scores are summed to obtain a total WOMAC score ranging from 0 to 96.
Higher scores indicate worse pain, stiffness, and functional limitation.
Measured: 6 months after the fifth once-weekly injection
Secondary outcomes (2)
Laboratory Assessment
Cartilage Oligomeric Matrix Protein (COMP)
Measured: Pre-Treatment
Laboratory Assessment
Cartilage Oligomeric Matrix Protein (COMP)
Measured: 3 months after the fifth once-weekly injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start2 Oct 2022
- Primary completion31 Mar 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Knee 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Sriwijaya
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Mohammad Hoesin Central General Hospital
- Responsible party
- Sponsor
- Investigators
- Radiyati U Partan, MD, Principal investigator, Universitas SriwijayaSurya Darma, MD, Study director, Universitas Sriwijaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05579665
- Sponsor's protocol ID
- 58/kepkrsmh/2022
- Status last verified
- Apr 2026
- First submitted
- 4 Oct 2022
- Last updated
- 22 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cerza F, Carni S, Carcangiu A, Di Vavo I, Schiavilla V, Pecora A, De Biasi G, Ciuffreda M. Comparison between hyaluronic acid and platelet-rich plasma, intra-articular infiltration in the treatment of gonarthrosis. Am J Sports Med. 2012 Dec;40(12):2822-7. doi: 10.1177/0363546512461902. Epub 2012 Oct 25.
PubMed 23104611Raeissadat SA, Rayegani SM, Hassanabadi H, Fathi M, Ghorbani E, Babaee M, Azma K. Knee Osteoarthritis Injection Choices: Platelet- Rich Plasma (PRP) Versus Hyaluronic Acid (A one-year randomized clinical trial). Clin Med Insights Arthritis Musculoskelet Disord. 2015 Jan 7;8:1-8. doi: 10.4137/CMAMD.S17894. eCollection 2015.
PubMed 25624776Montanez-Heredia E, Irizar S, Huertas PJ, Otero E, Del Valle M, Prat I, Diaz-Gallardo MS, Peran M, Marchal JA, Hernandez-Lamas Mdel C. Intra-Articular Injections of Platelet-Rich Plasma versus Hyaluronic Acid in the Treatment of Osteoarthritic Knee Pain: A Randomized Clinical Trial in the Context of the Spanish National Health Care System. Int J Mol Sci. 2016 Jul 2;17(7):1064. doi: 10.3390/ijms17071064.
PubMed 27384560Magnussen RA, Flanigan DC, Pedroza AD, Heinlein KA, Kaeding CC. Platelet rich plasma use in allograft ACL reconstructions: two-year clinical results of a MOON cohort study. Knee. 2013 Aug;20(4):277-80. doi: 10.1016/j.knee.2012.12.001. Epub 2012 Dec 24.
PubMed 23270598Ossendorff R, Walter SG, Schildberg FA, Khoury M, Salzmann GM. Controversies in regenerative medicine: should knee joint osteoarthritis be treated with mesenchymal stromal cells? Eur Cell Mater. 2022 Mar 17;43:98-111. doi: 10.22203/eCM.v043a09.
PubMed 35298024Gosens T, Den Oudsten BL, Fievez E, van 't Spijker P, Fievez A. Pain and activity levels before and after platelet-rich plasma injection treatment of patellar tendinopathy: a prospective cohort study and the influence of previous treatments. Int Orthop. 2012 Sep;36(9):1941-6. doi: 10.1007/s00264-012-1540-7. Epub 2012 Apr 27.
PubMed 22534958
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Platelet Rich Plasma (PRP), Conditioned Medium From Umbilical Cord Mesenchymal Stem Cell Culture (MSCs) Secretome and Hyaluronic Acid (HA) for the Treatment of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05579665
- Acronym / sponsor ID
- 58/kepkrsmh/2022
- Conditions
- Knee Osteoarthritis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Universitas SriwijayaUniversity, hospital or other
- Collaborators
- Dr. Mohammad Hoesin Central General Hospital
- Study start
- 2 Oct 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 14 Oct 2022 (actual)
- Results
- Posted 22 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The clinical trial will be carried out at the Dr. Moh. Hoesin Central Hospital, Palembang and planned from October 2022 to March 2023.
This study aims to compare the efficacy of Platelet Rich Plasma, Conditioned Medium From Umbilical Cord Mesenchymal Stem Cell (MSC) Culture Secretome and hyaluronic acid for the Treatment of Knee Osteoarthritis
Detailed description
In this, prospective, Open-label study, patients with mild to moderate symptomatic knee osteoarthritis will be randomized to receive either a series of platelet-rich plasma or hyaluronic acid or Conditioned Medium From Umbilical Cord Mesenchymal Stem Cell (MSC) Culture Secretome injections under ultrasound guidance. Each of the groups were given 5 times injection 3 cc platelet-rich plasma or 2 cc hyaluronic acid or 2cc Conditioned Medium From Umbilical Cord MSC Secretome at intervals 1 weeks.
Clinical data in the form of subjective outcome measures will be collected pre-treatment and 6 months after injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Platelet-rich Plasma (PRP) | Experimental | Biological: Platelet-rich PlasmaPlatelet-rich plasma administered 5 times as an intra-articular injection under ultrasound guidance as a series of one weekly injections to the affected knee. 1 weekly injections are of leukocyte poor, buffer/additive free, singe spin, platelet-rich plasma averaging 3mL in volume. |
| Conditioned Medium From Umbilical Cord Mesenchymal Stem Cell Culture (MSCs) Secretome | Experimental | Biological: Conditioned Medium From Umbilical Cord Mesenchymal Stem Cell Culture (MSCs) SecretomeConditioned Medium From Umbilical Cord Mesenchymal Stem Cell Culture (MSCs) Secretome administered 5 times as an intra-articular injection under ultrasound guidance as a series of one weekly injections to the affected knee. 1 weekly injections are Conditioned Medium From Umbilical Cord Mesenchymal Stem Cell Culture (MSCs) Secretome averaging 2 mL in volume. |
| Hyaluronic Acid (HA) | Experimental | Drug: Low Molecular Weight Hyaluronic AcidHyaluronic Acid administered 5 times as an intra-articular injection under ultrasound guidance as a series of one weekly injections to the affected knee. 1 weekly injections are of low molecular weight hyaluronan in a 2mL injection. |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients aged 30-60 years
- Suffering from grade 2 and 3 osteoarthritis (OA) was identified by two observers who differed accordingly the Kellgren and Lawrence research scale
- Patient with knee pain that had been continuing for at least 12 months with no relief using anti-inflammatory medications and that deteriorated with weight-bearing
- Patients can understand the nature of the study and written informed consent is given to patients
Key exclusion criteria (8 listed)
- Age > 60 years
- Acute Knee Osteoarthritis Effusions
- Patients are not willing to obey the study protocol
- There are signs of infection local or general infection or positive serology for HIV, hepatitis and syphilis
- There is a congenital disease that causes significant deformity of the knee can interfere with cell applications and interpret results
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 |
|---|---|---|
| Platelet-rich PlasmaAlso: PRPResearch participants own blood will be used to prepare the platelet rich plasma injectate. | Biological | Platelet-rich Plasma (PRP) |
| Conditioned Medium From Umbilical Cord Mesenchymal Stem Cell Culture (MSCs) SecretomeAlso: Conditioned Medium UC-MSCs SecretomeConditioned Medium UC-MSCs Secretome which will be injected into the affected knee using ultrasound guidance. | Biological | Conditioned Medium From Umbilical Cord Mesenchymal Stem Cell Culture (MSCs) Secretome |
| Low Molecular Weight Hyaluronic AcidAlso: HAlow molecular weight hyaluronic acid which will be injected into the affected knee using ultrasound guidance. | Drug | Hyaluronic Acid (HA) |
Primary outcome
Visual Analog Scale (VAS)
Time frame: Pre-Treatment
To asses pain score, score 1(good)-10(worst)
Visual Analog Scale (VAS)
Time frame: 3 months after the fifth once-weekly injection.
To asses pain score, score 1(good)-10(worst)
Visual Analog Scale (VAS)
Time frame: 6 months after the fifth once-weekly injection.
To asses pain score, score 1(good)-10(worst)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Pre-Treatment
To evaluate the condition of patients with osteoarthritis, including pain, stiffness, and physical functioning of the joints. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a self-administered questionnaire consisting of 24 items divided into three subscales: pain (0-20), stiffness (0-8), and physical function (0-68). Each item is scored on a Likert scale, and subscale scores are summed to obtain a total WOMAC score ranging from 0 to 96. Higher scores indicate worse pain, stiffness, and functional limitation.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 3 months after the fifth once-weekly injection
To evaluate the condition of patients with osteoarthritis, including pain, stiffness, and physical functioning of the joints. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a self-administered questionnaire consisting of 24 items divided into three subscales: pain (score range 0-20), stiffness (0-8), and physical function (0-68). Each item is scored on a Likert scale (0-4), and subscale scores are summed to obtain a total WOMAC score ranging from 0 to 96. Higher scores indicate worse pain, stiffness, and functional limitation.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 6 months after the fifth once-weekly injection
To evaluate the condition of patients with osteoarthritis, including pain, stiffness, and physical functioning of the joints. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a self-administered questionnaire consisting of 24 items divided into three subscales: pain (score range 0-20), stiffness (0-8), and physical function (0-68). Each item is scored on a Likert scale (0-4), and subscale scores are summed to obtain a total WOMAC score ranging from 0 to 96. Higher scores indicate worse pain, stiffness, and functional limitation.
2 secondary outcomes
Laboratory Assessment
Time frame: Pre-Treatment
Laboratory Assessment
Time frame: 3 months after the fifth once-weekly injection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23104611Cerza F, Carni S, Carcangiu A, Di Vavo I, Schiavilla V, Pecora A, De Biasi G, Ciuffreda M. Comparison between hyaluronic acid and platelet-rich plasma, intra-articular infiltration in the treatment of gonarthrosis. Am J Sports Med. 2012 Dec;40(12):2822-7. doi: 10.1177/0363546512461902. Epub 2012 Oct 25.
- Background: PubMed 25624776Raeissadat SA, Rayegani SM, Hassanabadi H, Fathi M, Ghorbani E, Babaee M, Azma K. Knee Osteoarthritis Injection Choices: Platelet- Rich Plasma (PRP) Versus Hyaluronic Acid (A one-year randomized clinical trial). Clin Med Insights Arthritis Musculoskelet Disord. 2015 Jan 7;8:1-8. doi: 10.4137/CMAMD.S17894. eCollection 2015.
- Background: PubMed 27384560Montanez-Heredia E, Irizar S, Huertas PJ, Otero E, Del Valle M, Prat I, Diaz-Gallardo MS, Peran M, Marchal JA, Hernandez-Lamas Mdel C. Intra-Articular Injections of Platelet-Rich Plasma versus Hyaluronic Acid in the Treatment of Osteoarthritic Knee Pain: A Randomized Clinical Trial in the Context of the Spanish National Health Care System. Int J Mol Sci. 2016 Jul 2;17(7):1064. doi: 10.3390/ijms17071064.
- Background: PubMed 23270598Magnussen RA, Flanigan DC, Pedroza AD, Heinlein KA, Kaeding CC. Platelet rich plasma use in allograft ACL reconstructions: two-year clinical results of a MOON cohort study. Knee. 2013 Aug;20(4):277-80. doi: 10.1016/j.knee.2012.12.001. Epub 2012 Dec 24.
- Background: PubMed 35298024Ossendorff R, Walter SG, Schildberg FA, Khoury M, Salzmann GM. Controversies in regenerative medicine: should knee joint osteoarthritis be treated with mesenchymal stromal cells? Eur Cell Mater. 2022 Mar 17;43:98-111. doi: 10.22203/eCM.v043a09.
- Background: PubMed 22534958Gosens T, Den Oudsten BL, Fievez E, van 't Spijker P, Fievez A. Pain and activity levels before and after platelet-rich plasma injection treatment of patellar tendinopathy: a prospective cohort study and the influence of previous treatments. Int Orthop. 2012 Sep;36(9):1941-6. doi: 10.1007/s00264-012-1540-7. Epub 2012 Apr 27.
- Individual participant dataSharing planned: No
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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.
Radiyati U Partan, MD principal investigator
Universitas Sriwijaya
Surya Darma, MD study director
Universitas Sriwijaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Platelet-rich Plasma, Conditioned Medium From Umbilical Cord Mesenchymal Stem Cell Culture (MSCs) Secretome and Low Molecular Weight Hyaluronic Acid in people with Knee Osteoarthritis, run by Universitas Sriwijaya at 1 site in Indonesia.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 22 May 2026. 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 Indonesia. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: Pre-Treatment). The study lists 6 primary outcomes in all. 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 NCT05579665, which also lists 6 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 22 May 2026.