Cholesterol Gallstone DissolutionNCT06972134

Synergistic Effects of Natural Oils and Herbal Extracts on Cholesterol Gallstone Dissolution: In Vitro Comparison With Rowachol®

A study testing Sesame Oil (SO) at 100 mg/mL in dissolving fluid., Extra Virgin Olive Oil (EVOO) at 100 mg/mL in dissolving fluid. and 50% Sesame Oil (SO) + 50% Extra Virgin Olive Oil (EVOO). in people with Cholesterol Gallstone Dissolution, run by University of Duhok at 1 site in Syria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Objective: This study aims to evaluate the effectiveness of a natural mixture (sesame oil, extra virgin olive oil, psyllium extract, and dandelion extract) in dissolving cholesterol gallstones compared to the standard medication, Rowachol®. Read more about this study

Who is it for?: Ages 40 to 50 years
Conditions the study is for: Cholesterol Gallstone Dissolution
What is being tested?: Sesame Oil (SO) at 100 mg/mL in dissolving fluid., Extra Virgin Olive Oil (EVOO) at 100 mg/mL in dissolving fluid. and 50% Sesame Oil (SO) + 50% Extra Virgin Olive Oil (EVOO).
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 55 participants
Where: 1 siteSyria
Study dates: 15 Dec 2023to 28 Aug 2024
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 40 to 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

----------------------------------- Diagnosis of cholesterol gallstones requiring surgical removal. Gallstones with ≥70% cholesterol composition (confirmed via FTIR). Gallstone size: 10-13 mm (measured via digital caliper). Gallstone weight: 120-150 mg (measured via electronic balance). Age range: 40-50 years. BMI: 20-30 kg/m².
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Who cannot join

----------------------------------- Hepatitis B/C infection. Chronic or acute illnesses (e.g., liver cirrhosis, hemolytic anemia). Pregnancy or lactation. History of malignancy. Participation in other clinical trials within the past 3 months.

Trial locations and contacts

1 site in 1 country.

Syria1 site

Arab International University
Damascus

Other trials in Syria

About this study

Official title: Synergistic Effects of Sesame Oil, Extra Virgin Olive Oil, Psyllium Extract, and Dandelion Extract on Cholesterol Gallstone Dissolution: An In Vitro Comparative Study Against Rowachol®

Objective:

This study aims to evaluate the effectiveness of a natural mixture (sesame oil, extra virgin olive oil, psyllium extract, and dandelion extract) in dissolving cholesterol gallstones compared to the standard medication, Rowachol®.

Methods:

In laboratory experiments, 70 cholesterol gallstones obtained from 55 patients were divided into seven groups. Each group was treated with different combinations of the natural ingredients or Rowachol®. The stones were monitored for 144 hours to measure dissolution rate and cholesterol release.

Conditions: Cholesterol Gallstone Dissolution
Being tested: Sesame Oil (SO) at 100 mg/mL in dissolving fluid., Extra Virgin Olive Oil (EVOO) at 100 mg/mL in dissolving fluid., 50% Sesame Oil (SO) + 50% Extra Virgin Olive Oil (EVOO)., 50% Psyllium Extract (PE) + 50% Oil Blend (50% SO + 50% EVOO)., Plantago ovata extract (AIU-BC-618-4) + AIU-BC-618-3
Keywords: Gallstone dissolution, Cholesterol gallstones, Natural oils, Herbal extracts, Oleic Acid, Taraxacin, Rowachol®, In vitro study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sesame Oil (SO) at 100 mg/mL in dissolving fluid.Dietary supplement
Also called Sesamum indicum oil (AIU-BC-618-1)
Pure Sesamum indicum oil (cold-pressed, unrefined) dissolved in BioIVT bile juice at 100 mg/mL. Prepared by homogenization (30 min, 37°C). Used as monotherapy.
Extra Virgin Olive Oil (EVOO) at 100 mg/mL in dissolving fluid.Dietary supplement
Also called Olea europaea oil (AIU-BC-618-2)
Pure Olea europaea oil (first cold-pressed, acidity ≤0.8%) dissolved in BioIVT bile juice at 100 mg/mL. Prepared by vortex mixing (15 min, 25°C). Used as monotherapy.
50% Sesame Oil (SO) + 50% Extra Virgin Olive Oil (EVOO).Dietary supplement
Also called AIU-BC-618-3 (Synergistic Oil Blend)
A 1:1 (v/v) blend of Sesamum indicum oil (AIU-BC-618-1) and Olea europaea oil (AIU-BC-618-2). Final concentration: 100 mg/mL in BioIVT bile juice. Prepared by mechanical stirring (1 hr, 40°C).
50% Psyllium Extract (PE) + 50% Oil Blend (50% SO + 50% EVOO).Dietary supplement
Also called Plantago ovata extract (AIU-BC-618-4) + AIU-BC-618-3
50% Plantago ovata mucilage extract (aqueous extraction, 65°C) + 50% AIU-BC-618-3 (SO+EVOO blend). Final concentration: 100 mg/mL in BioIVT bile juice. Prepared by sonication (20 min).
Plantago ovata extract (AIU-BC-618-4) + AIU-BC-618-3Dietary supplement
Also called Taraxacum officinale extract (AIU-BC-618-5) + AIU-BC-618-3
50% Taraxacum officinale root extract (ethanol-water extraction, 70°C) + 50% AIU-BC-618-3 (SO+EVOO blend). Final concentration: 100 mg/mL in BioIVT bile juice. Prepared by magnetic stirring (30 min, 50°C).
50% Herbal Extract (25% PE + 25% DE) + 50% Oil Blend (25% SO + 25% EVOO).Dietary supplement
Also called AIU-BC-618-6 (Full Synergy Formulation)
25% Plantago ovata extract (AIU-BC-618-4) + 25% Taraxacum officinale extract (AIU-BC-618-5) + 25% SO (AIU-BC-618-1) + 25% EVOO (AIU-BC-618-2). Final concentration: 100 mg/mL in BioIVT bile juice. Prepared by homogenization (45 min, 37°C).
Drug: Rowachol® (terpene extract) at 100 mg/mL in dissolving fluid.Drug
Also called Rowachol® (A. Nattermann & Cie. GmbH, Germany; FDA NDC 12345-678-90; Batch No. ROW-2024-SYR)
25% Plantago ovata extract (AIU-BC-618-4) + 25% Taraxacum officinale extract (AIU-BC-618-5) + 25% SO (AIU-BC-618-1) + 25% EVOO (AIU-BC-618-2). Final concentration: 100 mg/mL in BioIVT bile juice. Prepared by homogenization (45 min, 37°C).

Study groups in NCT06972134
Study group	Role	What they receive
Group 1 (G1)	Experimental	Sesame oil (SO) at 100 mg/mL in dissolving fluid. Receives: Dietary Supplement: Sesame Oil (SO) at 100 mg/mL in dissolving fluid.
Group 2 (G2)	Experimental	Extra Virgin Olive Oil (EVOO) at 100 mg/mL in dissolving fluid. Receives: Dietary Supplement: Extra Virgin Olive Oil (EVOO) at 100 mg/mL in dissolving fluid.
Group 3 (G3)	Experimental	50% Sesame Oil + 50% Extra virgin Olive Oil. Receives: Dietary Supplement: 50% Sesame Oil (SO) + 50% Extra Virgin Olive Oil (EVOO).
Group 4 (G4)	Experimental	50% Psyllium + 50% Oils (a mixture of 50% Sesame Oil + 50% Extra virgin Olive Oil). Receives: Dietary Supplement: 50% Psyllium Extract (PE) + 50% Oil Blend (50% SO + 50% EVOO).
Group 5 (G5)	Experimental	: 50% Dandelion + 50% Oils (a mixture of 50% Sesame Oil + 50% Extra virgin Olive Oil). Receives: Dietary Supplement: Plantago ovata extract (AIU-BC-618-4) + AIU-BC-618-3
Group 6 (G6)	Experimental	50% Herbal extract (50% Dandelion + 50% Psyllium) + 50% Oils (a mixture of 50% 50% Sesame Oil + 50% Extra virgin Olive Oil). Receives: Dietary Supplement: 50% Herbal Extract (25% PE + 25% DE) + 50% Oil Blend (25% SO + 25% EVOO).
Group 7 (G7) - Control	Active comparator	Rowachol® (terpene extract) at 100 mg/mL in dissolving fluid. Receives: Drug: Drug: Rowachol® (terpene extract) at 100 mg/mL in dissolving fluid.

What is being measured

The primary outcome is the main question the study is designed to answer.

Gallstone Dissolution Rate
Percentage reduction in gallstone weight after treatment.
Calculated using the formula:
DR%= (W initial-W final)/ W initial×100 Measurement Tool: Ohaus Adventurer Pro AV-2102 balance Unit of Measure: %
Measured: 48-hours, 96-hours, 144 hours
Cholesterol Release
Total cholesterol released from gallstones into the dissolving medium. Measurement Tool: Cholestech LX-20 autoanalyzer Unit of Measure: mg
Measured: 48-hours, 96-hours, 144 hours

Secondary outcomes (4)

Bioactive Compound Concentration
Quantification of key compounds (oleic acid, taraxacin, arabinoxylan, linoleic acid) in treatment solutions.
Measurement Tool: GC-MS (fatty acids), HPLC (plant extracts) Unit of Measure: mg/mL
Measured: Baseline (T0)
Synergistic Interaction Efficacy
Comparative analysis of dissolution rates and cholesterol release between combined and individual treatments.
Measurement Tool: Ohaus Balance + Cholestech LX-20 Unit of Measure: %, mg
Measured: 144 hours (T3)
Correlation: Compounds vs. Outcomes
Pearson correlation coefficients between bioactive compound concentrations and dissolution metrics.
Measurement Tool: Statistical analysis (SPSS v26) Unit of Measure: r-value (unitless)
Measured: 144 hours (T3)
Predictive Factors of Dissolution
Multiple regression analysis identifying key predictors (e.g., oleic acid, taraxacin) of efficacy.
Measurement Tool: Statistical analysis (SPSS v26) Unit of Measure: β-coefficient
Measured: 144 hours (T3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Dec 202328 Aug 2024

First posted14 May 2025
Study start15 Dec 2023
Primary completion17 May 2024
Study completion28 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Cholesterol Gallstone DissolutionStudies 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: Single blind
Who is masked: Outcomes assessor
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06972134
Sponsor's protocol ID: AIU-618-11GR-1358
Other IDs: AIU-618-11GR
Status last verified: May 2025
First submitted: 28 Apr 2025
Last updated: 18 May 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Fan M, Zhang X, Song H, Zhang Y. Dandelion (Taraxacum Genus): A Review of Chemical Constituents and Pharmacological Effects. Molecules. 2023 Jun 27;28(13):5022. doi: 10.3390/molecules28135022.
PubMed 37446683
Kumar, Pandey J, Kumar P, et al.; Psyllium Mucilage and Its Use in Pharmaceutical Field: An Overview. Current Synthetic and Systems Biology 2017;05. doi: 10.4172/2332-0737.1000134.
Zommara MA, Swelam S, Raya-Alvarez E, Imaizumi K, Elmahdy A, Alkhudhayri DA, Aljehani AA, Agil A, Elmahallawy EK. Nutritional and potential health benefits of chufa oil, olive oil, and anhydrous milk fat against gallstone disease in a C57BL/6N mouse model. Front Nutr. 2024 Sep 26;11:1445484. doi: 10.3389/fnut.2024.1445484. eCollection 2024.
PubMed 39391681
Vahedi H, Atefi M, Entezari MH, Hassanzadeh A. The effect of sesame oil consumption compared to sunflower oil on lipid profile, blood pressure, and anthropometric indices in women with non-alcoholic fatty liver disease: a randomized double-blind controlled trial. Trials. 2022 Jul 8;23(1):551. doi: 10.1186/s13063-022-06451-1.
PubMed 35804451
Stokes CS, Gluud LL, Casper M, Lammert F. Ursodeoxycholic acid and diets higher in fat prevent gallbladder stones during weight loss: a meta-analysis of randomized controlled trials. Clin Gastroenterol Hepatol. 2014 Jul;12(7):1090-1100.e2; quiz e61. doi: 10.1016/j.cgh.2013.11.031. Epub 2013 Dec 7.
PubMed 24321208

Study at a glance

From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Synergistic Effects of Sesame Oil, Extra Virgin Olive Oil, Psyllium Extract, and Dandelion Extract on Cholesterol Gallstone Dissolution: An In Vitro Comparative Study Against Rowachol®
ClinicalTrials.gov ID: NCT06972134
Acronym / sponsor ID: AIU-618-11GR-1358
Conditions: Cholesterol Gallstone Dissolution
Keywords: Gallstone dissolution, Cholesterol gallstones, Natural oils, Herbal extracts, Oleic Acid, Taraxacin, Rowachol®, In vitro study
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: University of DuhokUniversity, hospital or other
Study start: 15 Dec 2023 (actual)
Primary completion: 17 May 2024 (actual)
Study completion: 28 Aug 2024 (actual)
First posted: 14 May 2025 (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.

Objective:

Methods:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 7

Arm	Type	Receives
Group 1 (G1)	Experimental	Dietary Supplement: Sesame Oil (SO) at 100 mg/mL in dissolving fluid.Sesame oil (SO) at 100 mg/mL in dissolving fluid.
Group 2 (G2)	Experimental	Dietary Supplement: Extra Virgin Olive Oil (EVOO) at 100 mg/mL in dissolving fluid.Extra Virgin Olive Oil (EVOO) at 100 mg/mL in dissolving fluid.
Group 3 (G3)	Experimental	Dietary Supplement: 50% Sesame Oil (SO) + 50% Extra Virgin Olive Oil (EVOO).50% Sesame Oil + 50% Extra virgin Olive Oil.
Group 4 (G4)	Experimental	Dietary Supplement: 50% Psyllium Extract (PE) + 50% Oil Blend (50% SO + 50% EVOO).50% Psyllium + 50% Oils (a mixture of 50% Sesame Oil + 50% Extra virgin Olive Oil).
Group 5 (G5)	Experimental	Dietary Supplement: Plantago ovata extract (AIU-BC-618-4) + AIU-BC-618-3: 50% Dandelion + 50% Oils (a mixture of 50% Sesame Oil + 50% Extra virgin Olive Oil).
Group 6 (G6)	Experimental	Dietary Supplement: 50% Herbal Extract (25% PE + 25% DE) + 50% Oil Blend (25% SO + 25% EVOO).50% Herbal extract (50% Dandelion + 50% Psyllium) + 50% Oils (a mixture of 50% 50% Sesame Oil + 50% Extra virgin Olive Oil).
Group 7 (G7) - Control	Active comparator	Drug: Drug: Rowachol® (terpene extract) at 100 mg/mL in dissolving fluid.Rowachol® (terpene extract) at 100 mg/mL in dissolving fluid.

Who may qualify

Ages: 40 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

----------------------------------- Diagnosis of cholesterol gallstones requiring surgical removal. Gallstones with ≥70% cholesterol composition (confirmed via FTIR). Gallstone size: 10-13 mm (measured via digital caliper). Gallstone weight: 120-150 mg (measured via electronic balance). Age range: 40-50 years. BMI: 20-30 kg/m².
------------------------------------------------------------------------------------------------------------------------------

Key exclusion criteria (1 listed)

----------------------------------- Hepatitis B/C infection. Chronic or acute illnesses (e.g., liver cirrhosis, hemolytic anemia). Pregnancy or lactation. History of malignancy. Participation in other clinical trials within the past 3 months.

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
Sesame Oil (SO) at 100 mg/mL in dissolving fluid.Also: Sesamum indicum oil (AIU-BC-618-1)Pure Sesamum indicum oil (cold-pressed, unrefined) dissolved in BioIVT bile juice at 100 mg/mL. Prepared by homogenization (30 min, 37°C). Used as monotherapy.	Dietary supplement	Group 1 (G1)
Extra Virgin Olive Oil (EVOO) at 100 mg/mL in dissolving fluid.Also: Olea europaea oil (AIU-BC-618-2)Pure Olea europaea oil (first cold-pressed, acidity ≤0.8%) dissolved in BioIVT bile juice at 100 mg/mL. Prepared by vortex mixing (15 min, 25°C). Used as monotherapy.	Dietary supplement	Group 2 (G2)
50% Sesame Oil (SO) + 50% Extra Virgin Olive Oil (EVOO).Also: AIU-BC-618-3 (Synergistic Oil Blend)A 1:1 (v/v) blend of Sesamum indicum oil (AIU-BC-618-1) and Olea europaea oil (AIU-BC-618-2). Final concentration: 100 mg/mL in BioIVT bile juice. Prepared by mechanical stirring (1 hr, 40°C).	Dietary supplement	Group 3 (G3)
50% Psyllium Extract (PE) + 50% Oil Blend (50% SO + 50% EVOO).Also: Plantago ovata extract (AIU-BC-618-4) + AIU-BC-618-350% Plantago ovata mucilage extract (aqueous extraction, 65°C) + 50% AIU-BC-618-3 (SO+EVOO blend). Final concentration: 100 mg/mL in BioIVT bile juice. Prepared by sonication (20 min).	Dietary supplement	Group 4 (G4)
Plantago ovata extract (AIU-BC-618-4) + AIU-BC-618-3Also: Taraxacum officinale extract (AIU-BC-618-5) + AIU-BC-618-350% Taraxacum officinale root extract (ethanol-water extraction, 70°C) + 50% AIU-BC-618-3 (SO+EVOO blend). Final concentration: 100 mg/mL in BioIVT bile juice. Prepared by magnetic stirring (30 min, 50°C).	Dietary supplement	Group 5 (G5)
50% Herbal Extract (25% PE + 25% DE) + 50% Oil Blend (25% SO + 25% EVOO).Also: AIU-BC-618-6 (Full Synergy Formulation)25% Plantago ovata extract (AIU-BC-618-4) + 25% Taraxacum officinale extract (AIU-BC-618-5) + 25% SO (AIU-BC-618-1) + 25% EVOO (AIU-BC-618-2). Final concentration: 100 mg/mL in BioIVT bile juice. Prepared by homogenization (45 min, 37°C).	Dietary supplement	Group 6 (G6)
Drug: Rowachol® (terpene extract) at 100 mg/mL in dissolving fluid.Also: Rowachol® (A. Nattermann & Cie. GmbH, Germany; FDA NDC 12345-678-90; Batch No. ROW-2024-SYR)25% Plantago ovata extract (AIU-BC-618-4) + 25% Taraxacum officinale extract (AIU-BC-618-5) + 25% SO (AIU-BC-618-1) + 25% EVOO (AIU-BC-618-2). Final concentration: 100 mg/mL in BioIVT bile juice. Prepared by homogenization (45 min, 37°C).	Drug	Group 7 (G7) - Control

Primary outcome

Gallstone Dissolution Rate
Time frame: 48-hours, 96-hours, 144 hours
Percentage reduction in gallstone weight after treatment. Calculated using the formula: DR%= (W initial-W final)/ W initial×100 Measurement Tool: Ohaus Adventurer Pro AV-2102 balance Unit of Measure: %
Cholesterol Release
Time frame: 48-hours, 96-hours, 144 hours
Total cholesterol released from gallstones into the dissolving medium. Measurement Tool: Cholestech LX-20 autoanalyzer Unit of Measure: mg

4 secondary outcomes

Bioactive Compound Concentration
Time frame: Baseline (T0)
Synergistic Interaction Efficacy
Time frame: 144 hours (T3)
Correlation: Compounds vs. Outcomes
Time frame: 144 hours (T3)
Predictive Factors of Dissolution
Time frame: 144 hours (T3)

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 18 May 2025.
Background: PubMed 37446683Fan M, Zhang X, Song H, Zhang Y. Dandelion (Taraxacum Genus): A Review of Chemical Constituents and Pharmacological Effects. Molecules. 2023 Jun 27;28(13):5022. doi: 10.3390/molecules28135022.
BackgroundKumar, Pandey J, Kumar P, et al.; Psyllium Mucilage and Its Use in Pharmaceutical Field: An Overview. Current Synthetic and Systems Biology 2017;05. doi: 10.4172/2332-0737.1000134.
Background: PubMed 39391681Zommara MA, Swelam S, Raya-Alvarez E, Imaizumi K, Elmahdy A, Alkhudhayri DA, Aljehani AA, Agil A, Elmahallawy EK. Nutritional and potential health benefits of chufa oil, olive oil, and anhydrous milk fat against gallstone disease in a C57BL/6N mouse model. Front Nutr. 2024 Sep 26;11:1445484. doi: 10.3389/fnut.2024.1445484. eCollection 2024.
Background: PubMed 35804451Vahedi H, Atefi M, Entezari MH, Hassanzadeh A. The effect of sesame oil consumption compared to sunflower oil on lipid profile, blood pressure, and anthropometric indices in women with non-alcoholic fatty liver disease: a randomized double-blind controlled trial. Trials. 2022 Jul 8;23(1):551. doi: 10.1186/s13063-022-06451-1.
Background: PubMed 24321208Stokes CS, Gluud LL, Casper M, Lammert F. Ursodeoxycholic acid and diets higher in fat prevent gallbladder stones during weight loss: a meta-analysis of randomized controlled trials. Clin Gastroenterol Hepatol. 2014 Jul;12(7):1090-1100.e2; quiz e61. doi: 10.1016/j.cgh.2013.11.031. Epub 2013 Dec 7.
Individual participant dataSharing planned: Undecided

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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 1 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 18 May 2025. 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 Syria. 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?

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?

Gallstone Dissolution Rate (time frame: 48-hours, 96-hours, 144 hours). The study lists 2 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 NCT06972134, which also lists 5 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 18 May 2025.