Uremic PruritisPhase 2NCT05341843
Sertraline Effect in Uremic Pruritis
A Phase 2 study testing sertraline in people with Uremic Pruritis, run by Alexandria University at 1 site in Egypt.
Trial summary
This study aims to assess the effect of sertraline on uremic pruritis in patients undergoing regular haemodialysis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Uremic Pruritis
- What is being tested?
- sertraline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2022to 1 Oct 2022
- Phase
- Phase 2
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥1 month of maintenance haemodialysis, 3 times per week for 4 hours.
- Adult patients with ages between 18-80 years.
Who cannot join
- Primary skin diseases (eczema, psoriasis, allergic dermatitis or drug rash).
- Peripheral neuropathy, thyroid disease, leukemia, lymphoma, liver disease, Systemic lupus erythematosus or pregnancy.
- Patients who consumed emollients cream, antihistamine, opioid antagonist, immunosuppressants, cholestyramine, corticosteroids or UVB phototherapy 1 month before study.
- calcium X phosphorus (Ca X P) >55.0 mg/dl, P >5.5 mg/dl, parathyroid hormone (PTH) >450 pg/ml.
- Selective serotonin reuptake inhibitors intolerance.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Sertraline in Alleviating Uremic Pruritis in Hemodialysis Patients
This study aims to assess the effect of sertraline on uremic pruritis in patients undergoing regular haemodialysis.
Read the detailed description
The reported prevalence of uremic pruritus in adult hemodialysis patients has varied over the years, and some studies suggest the prevalence may be decreasing with more effective dialysis. One of the largest trials (the Dialysis Outcomes and Practice Patterns Study [DOPPS]) reported that the prevalence of moderate pruritus remained constant at 18 percent until 2015.
A direct role for proinflammatory T cells and cytokines is suggested by studies that showed higher levels of proinflammatory T helper-1 (TH1) cells, C-reactive protein, interleukin-6, and interleukin-2 levels among hemodialysis patients versus those without pruritus. Also, histamine release from mast cells, other pruritogens and xerosis have been all implicated in the pathogenesis of uremic pruritus.
Less convincing associations have also been made to anemia, male sex, increased beta-2 microglobulin levels, serotype human leukocyte antigen (HLA)-B35, and comorbidities including congestive heart failure and neurologic disease. The risk of uremic pruritis appears to be independent of ethnicity, type of dialysis, and underlying renal disease. No single cause underlying uremic pruritus has been identified. Multiple factors have been associated in observational studies, and supportive therapies that are used to treat uremic pruritus have targeted such factors.
High quality evidence on which to base recommendations for the treatment of uremic pruritus is limited. Many pharmacologic treatments have been proposed for uremic pruritis through different clinical trials. However, the results were quite variable and most of these studies were small uncontrolled trials and hence they were flawed.
Several studies have revealed that the selective serotonin reuptake inhibitors (SSRI) could reduce the severity of pruritus. Sertraline hydrochloride is a selective serotonin reuptake inhibitor which established improvement in itching in patients with cholestatic pruritis. This was supported by Browning et al. (2003) whose study showed 86% of subjects who had been given sertraline for another indication improved considerably with pruritus disappearing in 30% of the subjects.
Generally, most of the previous research has tended to focus on cholestatic pruritis rather than uremic pruritis. Although enough is known to determine a reasonable approach to a patient with uremic pruritus, more research is needed to understand the pathophysiology of this condition and to establish more reliable treatments. Hence, this study is organized in an attempt to find out the effect of sertraline on alleviation of uremic pruritus.
- Conditions
- Uremic Pruritis
- Being tested
- sertraline, placebo
- Keywords
- sertraline, hemodialysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sertralineDrug
sertraline at the intended dose of 50 mg twice daily for 8 weeks.
placeboDrug
a placebo in the form of multivitamin tablets similar to the experimental drugs with the same regimen (one tablet /day for 8 weeks)
| Study group | Role | What they receive |
|---|---|---|
| sertraline | Experimental | they will receive sertraline at the intended dose of 50 mg twice daily for 8 weeks. Receives: Drug: sertraline |
| placebo | Placebo comparator | They will receive a placebo in the form of multivitamin tablets similar to the experimental drug with the same regimen, as one tablet /day for 8 weeks Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in uremic pruritis intensity
Assessment of pruritis will be done before and after the course of treatment (8 weeks) through the following scores:
- Visual analogue scale (VAS) II) 5D itch scale
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start1 May 2022
- Primary completion1 Sep 2022
- Study completion1 Oct 2022
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 Uremic PruritisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This research is a double-blinded randomized multicentric clinical trial in which 50 haemodialysis patients will be randomly assigned to one of the study groups using block randomization with a ratio of 1:1. * Group A: 25 patients will receive sertraline at the intended dose of 50 mg twice daily for 8 weeks. * Group B: 25 patients will receive a placebo.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mamdouh Mahmoud Mohamed Elsayed , MD, Alexandria University
- Investigators
- Mohamed Mamdouh Elsayed, MD, Principal investigator, lecturerSherif aziz Zaki, MD, Study chair, professorIman ezzat El Gohary, MD, Study chair, professorHeidi Hesham Abd El Hamid, MBBCh, Study chair, Resident
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341843
- Sponsor's protocol ID
- sertraline and uremic pruritis
- Status last verified
- Dec 2022
- First submitted
- 18 Apr 2022
- Last updated
- 14 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Patel TS, Freedman BI, Yosipovitch G. An update on pruritus associated with CKD. Am J Kidney Dis. 2007 Jul;50(1):11-20. doi: 10.1053/j.ajkd.2007.03.010.
PubMed 17591521Pisoni RL, Wikstrom B, Elder SJ, Akizawa T, Asano Y, Keen ML, Saran R, Mendelssohn DC, Young EW, Port FK. Pruritus in haemodialysis patients: International results from the Dialysis Outcomes and Practice Patterns Study (DOPPS). Nephrol Dial Transplant. 2006 Dec;21(12):3495-505. doi: 10.1093/ndt/gfl461. Epub 2006 Sep 12.
PubMed 16968725Pauli-Magnus C, Mikus G, Alscher DM, Kirschner T, Nagel W, Gugeler N, Risler T, Berger ED, Kuhlmann U, Mettang T. Naltrexone does not relieve uremic pruritus: results of a randomized, double-blind, placebo-controlled crossover study. J Am Soc Nephrol. 2000 Mar;11(3):514-519. doi: 10.1681/ASN.V113514.
PubMed 10703675Rayner HC, Larkina M, Wang M, Graham-Brown M, van der Veer SN, Ecder T, Hasegawa T, Kleophas W, Bieber BA, Tentori F, Robinson BM, Pisoni RL. International Comparisons of Prevalence, Awareness, and Treatment of Pruritus in People on Hemodialysis. Clin J Am Soc Nephrol. 2017 Dec 7;12(12):2000-2007. doi: 10.2215/CJN.03280317. Epub 2017 Sep 18.
PubMed 28923831Kimmel M, Alscher DM, Dunst R, Braun N, Machleidt C, Kiefer T, Stulten C, van der Kuip H, Pauli-Magnus C, Raub U, Kuhlmann U, Mettang T. The role of micro-inflammation in the pathogenesis of uraemic pruritus in haemodialysis patients. Nephrol Dial Transplant. 2006 Mar;21(3):749-55. doi: 10.1093/ndt/gfi204. Epub 2005 Oct 25.
PubMed 16249205Fallahzadeh MK, Roozbeh J, Geramizadeh B, Namazi MR. Interleukin-2 serum levels are elevated in patients with uremic pruritus: a novel finding with practical implications. Nephrol Dial Transplant. 2011 Oct;26(10):3338-44. doi: 10.1093/ndt/gfr053. Epub 2011 Mar 3.
PubMed 21372257Charlesworth EN, Beltrani VS. Pruritic dermatoses: overview of etiology and therapy. Am J Med. 2002 Dec 16;113 Suppl 9A:25S-33S. doi: 10.1016/s0002-9343(02)01434-1.
PubMed 12517579Stander S, Bockenholt B, Schurmeyer-Horst F, Weishaupt C, Heuft G, Luger TA, Schneider G. Treatment of chronic pruritus with the selective serotonin re-uptake inhibitors paroxetine and fluvoxamine: results of an open-labelled, two-arm proof-of-concept study. Acta Derm Venereol. 2009;89(1):45-51. doi: 10.2340/00015555-0553.
PubMed 19197541Mayo MJ, Handem I, Saldana S, Jacobe H, Getachew Y, Rush AJ. Sertraline as a first-line treatment for cholestatic pruritus. Hepatology. 2007 Mar;45(3):666-74. doi: 10.1002/hep.21553.
PubMed 17326161Snit M, Gawlik R, Lacka-Gazdzik B, Kuzniewicz R, Dwornicki M, Owczarek A, Walaszczyk M, Grabiec P, Grzeszczak W. Substance P and intensity of pruritus in hemodialysis and peritoneal dialysis patients. Med Sci Monit. 2013 Sep 2;19:723-32. doi: 10.12659/MSM.889349.
PubMed 23995243Ko MJ, Wu HY, Chen HY, Chiu YL, Hsu SP, Pai MF, Ju-Yehyang, Lai CF, Lu HM, Huang SC, Yang SY, Wen SY, Chiu HC, Hu FC, Peng YS, Jee SH. Uremic pruritus, dialysis adequacy, and metabolic profiles in hemodialysis patients: a prospective 5-year cohort study. PLoS One. 2013 Aug 6;8(8):e71404. doi: 10.1371/journal.pone.0071404. Print 2013.
PubMed 23940749Wu HY, Peng YS, Chen HY, Tsai WC, Yang JY, Hsu SP, Pai MF, Lu HM, Chiang JF, Ko MJ, Wen SY, Chiu HC. A Comparison of Uremic Pruritus in Patients Receiving Peritoneal Dialysis and Hemodialysis. Medicine (Baltimore). 2016 Mar;95(9):e2935. doi: 10.1097/MD.0000000000002935.
PubMed 26945400Elman S, Hynan LS, Gabriel V, Mayo MJ. The 5-D itch scale: a new measure of pruritus. Br J Dermatol. 2010 Mar;162(3):587-93. doi: 10.1111/j.1365-2133.2009.09586.x. Epub 2009 Dec 1.
PubMed 19995367Elsayed MM, Elgohary IE, Abdelhamid HHS, Zaki SA. The effectiveness of sertraline in alleviating uremic pruritus in hemodialysis patients: a randomized clinical trial. BMC Nephrol. 2023 Jun 3;24(1):155. doi: 10.1186/s12882-023-03212-3.
PubMed 37270517
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Sertraline in Alleviating Uremic Pruritis in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT05341843
- Acronym / sponsor ID
- sertraline and uremic pruritis
- Conditions
- Uremic Pruritis
- Keywords
- sertraline, hemodialysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 22 Apr 2022 (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.
This study aims to assess the effect of sertraline on uremic pruritis in patients undergoing regular haemodialysis.
Detailed description
The reported prevalence of uremic pruritus in adult hemodialysis patients has varied over the years, and some studies suggest the prevalence may be decreasing with more effective dialysis. One of the largest trials (the Dialysis Outcomes and Practice Patterns Study [DOPPS]) reported that the prevalence of moderate pruritus remained constant at 18 percent until 2015.
A direct role for proinflammatory T cells and cytokines is suggested by studies that showed higher levels of proinflammatory T helper-1 (TH1) cells, C-reactive protein, interleukin-6, and interleukin-2 levels among hemodialysis patients versus those without pruritus. Also, histamine release from mast cells, other pruritogens and xerosis have been all implicated in the pathogenesis of uremic pruritus.
Less convincing associations have also been made to anemia, male sex, increased beta-2 microglobulin levels, serotype human leukocyte antigen (HLA)-B35, and comorbidities including congestive heart failure and neurologic disease. The risk of uremic pruritis appears to be independent of ethnicity, type of dialysis, and underlying renal disease. No single cause underlying uremic pruritus has been identified. Multiple factors have been associated in observational studies, and supportive therapies that are used to treat uremic pruritus have targeted such factors.
High quality evidence on which to base recommendations for the treatment of uremic pruritus is limited. Many pharmacologic treatments have been proposed for uremic pruritis through different clinical trials. However, the results were quite variable and most of these studies were small uncontrolled trials and hence they were flawed.
Several studies have revealed that the selective serotonin reuptake inhibitors (SSRI) could reduce the severity of pruritus. Sertraline hydrochloride is a selective serotonin reuptake inhibitor which established improvement in itching in patients with cholestatic pruritis. This was supported by Browning et al. (2003) whose study showed 86% of subjects who had been given sertraline for another indication improved considerably with pruritus disappearing in 30% of the subjects.
Generally, most of the previous research has tended to focus on cholestatic pruritis rather than uremic pruritis. Although enough is known to determine a reasonable approach to a patient with uremic pruritus, more research is needed to understand the pathophysiology of this condition and to establish more reliable treatments. Hence, this study is organized in an attempt to find out the effect of sertraline on alleviation of uremic pruritus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- This research is a double-blinded randomized multicentric clinical trial in which 50 haemodialysis patients will be randomly assigned to one of the study groups using block randomization with a ratio of 1:1. * Group A: 25 patients will receive sertraline at the intended dose of 50 mg twice daily for 8 weeks. * Group B: 25 patients will receive a placebo.
| Arm | Type | Receives |
|---|---|---|
| sertraline | Experimental | Drug: sertralinethey will receive sertraline at the intended dose of 50 mg twice daily for 8 weeks. |
| placebo | Placebo comparator | Drug: placeboThey will receive a placebo in the form of multivitamin tablets similar to the experimental drug with the same regimen, as one tablet /day for 8 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ≥1 month of maintenance haemodialysis, 3 times per week for 4 hours.
- Adult patients with ages between 18-80 years.
Key exclusion criteria (5 listed)
- Primary skin diseases (eczema, psoriasis, allergic dermatitis or drug rash).
- Peripheral neuropathy, thyroid disease, leukemia, lymphoma, liver disease, Systemic lupus erythematosus or pregnancy.
- Patients who consumed emollients cream, antihistamine, opioid antagonist, immunosuppressants, cholestyramine, corticosteroids or UVB phototherapy 1 month before study.
- calcium X phosphorus (Ca X P) >55.0 mg/dl, P >5.5 mg/dl, parathyroid hormone (PTH) >450 pg/ml.
- Selective serotonin reuptake inhibitors intolerance.
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 |
|---|---|---|
| sertralinesertraline at the intended dose of 50 mg twice daily for 8 weeks. | Drug | sertraline |
| placeboa placebo in the form of multivitamin tablets similar to the experimental drugs with the same regimen (one tablet /day for 8 weeks) | Drug | placebo |
Primary outcome
change in uremic pruritis intensity
Time frame: 8 weeks
Assessment of pruritis will be done before and after the course of treatment (8 weeks) through the following scores: I) Visual analogue scale (VAS) II) 5D itch scale
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Background: PubMed 17591521Patel TS, Freedman BI, Yosipovitch G. An update on pruritus associated with CKD. Am J Kidney Dis. 2007 Jul;50(1):11-20. doi: 10.1053/j.ajkd.2007.03.010.
- Background: PubMed 16968725Pisoni RL, Wikstrom B, Elder SJ, Akizawa T, Asano Y, Keen ML, Saran R, Mendelssohn DC, Young EW, Port FK. Pruritus in haemodialysis patients: International results from the Dialysis Outcomes and Practice Patterns Study (DOPPS). Nephrol Dial Transplant. 2006 Dec;21(12):3495-505. doi: 10.1093/ndt/gfl461. Epub 2006 Sep 12.
- Background: PubMed 10703675Pauli-Magnus C, Mikus G, Alscher DM, Kirschner T, Nagel W, Gugeler N, Risler T, Berger ED, Kuhlmann U, Mettang T. Naltrexone does not relieve uremic pruritus: results of a randomized, double-blind, placebo-controlled crossover study. J Am Soc Nephrol. 2000 Mar;11(3):514-519. doi: 10.1681/ASN.V113514.
- Background: PubMed 28923831Rayner HC, Larkina M, Wang M, Graham-Brown M, van der Veer SN, Ecder T, Hasegawa T, Kleophas W, Bieber BA, Tentori F, Robinson BM, Pisoni RL. International Comparisons of Prevalence, Awareness, and Treatment of Pruritus in People on Hemodialysis. Clin J Am Soc Nephrol. 2017 Dec 7;12(12):2000-2007. doi: 10.2215/CJN.03280317. Epub 2017 Sep 18.
- Background: PubMed 16249205Kimmel M, Alscher DM, Dunst R, Braun N, Machleidt C, Kiefer T, Stulten C, van der Kuip H, Pauli-Magnus C, Raub U, Kuhlmann U, Mettang T. The role of micro-inflammation in the pathogenesis of uraemic pruritus in haemodialysis patients. Nephrol Dial Transplant. 2006 Mar;21(3):749-55. doi: 10.1093/ndt/gfi204. Epub 2005 Oct 25.
- Background: PubMed 21372257Fallahzadeh MK, Roozbeh J, Geramizadeh B, Namazi MR. Interleukin-2 serum levels are elevated in patients with uremic pruritus: a novel finding with practical implications. Nephrol Dial Transplant. 2011 Oct;26(10):3338-44. doi: 10.1093/ndt/gfr053. Epub 2011 Mar 3.
- Background: PubMed 12517579Charlesworth EN, Beltrani VS. Pruritic dermatoses: overview of etiology and therapy. Am J Med. 2002 Dec 16;113 Suppl 9A:25S-33S. doi: 10.1016/s0002-9343(02)01434-1.
- Background: PubMed 19197541Stander S, Bockenholt B, Schurmeyer-Horst F, Weishaupt C, Heuft G, Luger TA, Schneider G. Treatment of chronic pruritus with the selective serotonin re-uptake inhibitors paroxetine and fluvoxamine: results of an open-labelled, two-arm proof-of-concept study. Acta Derm Venereol. 2009;89(1):45-51. doi: 10.2340/00015555-0553.
- Background: PubMed 17326161Mayo MJ, Handem I, Saldana S, Jacobe H, Getachew Y, Rush AJ. Sertraline as a first-line treatment for cholestatic pruritus. Hepatology. 2007 Mar;45(3):666-74. doi: 10.1002/hep.21553.
- Background: PubMed 23995243Snit M, Gawlik R, Lacka-Gazdzik B, Kuzniewicz R, Dwornicki M, Owczarek A, Walaszczyk M, Grabiec P, Grzeszczak W. Substance P and intensity of pruritus in hemodialysis and peritoneal dialysis patients. Med Sci Monit. 2013 Sep 2;19:723-32. doi: 10.12659/MSM.889349.
- Background: PubMed 23940749Ko MJ, Wu HY, Chen HY, Chiu YL, Hsu SP, Pai MF, Ju-Yehyang, Lai CF, Lu HM, Huang SC, Yang SY, Wen SY, Chiu HC, Hu FC, Peng YS, Jee SH. Uremic pruritus, dialysis adequacy, and metabolic profiles in hemodialysis patients: a prospective 5-year cohort study. PLoS One. 2013 Aug 6;8(8):e71404. doi: 10.1371/journal.pone.0071404. Print 2013.
- Background: PubMed 26945400Wu HY, Peng YS, Chen HY, Tsai WC, Yang JY, Hsu SP, Pai MF, Lu HM, Chiang JF, Ko MJ, Wen SY, Chiu HC. A Comparison of Uremic Pruritus in Patients Receiving Peritoneal Dialysis and Hemodialysis. Medicine (Baltimore). 2016 Mar;95(9):e2935. doi: 10.1097/MD.0000000000002935.
- Individual participant dataSharing planned: Undecided
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Active, not recruitingObservational study
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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.
Mohamed Mamdouh Elsayed, MD principal investigator
lecturer
Sherif aziz Zaki, MD study chair
professor
Iman ezzat El Gohary, MD study chair
professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sertraline in people with Uremic Pruritis, run by Alexandria University at 1 site in Egypt.
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 2 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: finished, as of the sponsor's last update on 14 Dec 2022. 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 Egypt. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
change in uremic pruritis intensity (time frame: 8 weeks). 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 NCT05341843, 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 14 Dec 2022.