A Study of Sabroxy™ (Oroxylum Indicum Extract) for Improving Cognitive Function in Adults With Mild Memory Concerns

September 22, 2025 updated by: SF Research Institute, Inc.

A Randomized, Double-Blind Placebo Controlled Study to Assess the Effects of an Oroxylum Indicum Extract (Sabroxy™) on Cognitive Function in Adults With Self-reported, Mild Cognitive Impairmentx

This study is testing whether Sabroxy™ (Oroxylum indicum extract) can improve memory and thinking in older adults who report mild problems with their cognition. The study will also measure levels of a protein in the blood called BDNF (Brain-Derived Neurotrophic Factor), which is linked to brain health.

The main questions are:

Does taking Sabroxy™ improve memory, focus, and overall cognitive performance compared to placebo (a capsule that looks the same but has no active ingredient)?

Does Sabroxy™ increase levels of BDNF in the blood?

About 80 participants between the ages of 60 and 85 will take part. All participants will be randomly assigned to receive either Sabroxy™ or placebo twice daily for 12 weeks. Neither the participants nor the researchers will know which group they are in (double-blind design).

During the study, participants will:

Take one capsule twice daily after meals.

Complete computerized cognitive tests (COMPASS), interviews with the Montreal Cognitive Assessment (MoCA), and self-assessment questionnaires on memory and thinking.

Provide blood samples to measure BDNF.

Attend 4 clinic visits (baseline, week 4, week 8, and week 12).

Keep a daily diary to track product use and study compliance.

The goal is to see whether Sabroxy™ can safely and effectively support cognitive health in older adults with mild memory concerns.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effects of Sabroxy™ (Oroxylum indicum extract) on cognitive function in adults with self-reported, mild cognitive impairment.

Approximately 84 participants will be recruited, with a goal of 80 completing the study. Participants will be between 60-85 years old, in generally good health, and living independently. Eligible participants must report concerns about their memory or thinking, confirmed with a screening test (MoCA).

After screening and baseline assessments, participants will be randomly assigned to receive either Sabroxy™ or placebo. Both products will look identical to ensure blinding. Participants will take one capsule twice daily, after meals, for 12 weeks.

The study assessments include:

Computerized Mental Performance Assessment (COMPASS): tests of memory, attention, and reaction time.

Montreal Cognitive Assessment (MoCA): an interviewer-administered cognitive test.

Mild Cognitive Impairment Questionnaire: a self-reported measure of memory and thinking concerns.

Blood samples: to measure Brain-Derived Neurotrophic Factor (BDNF) at baseline and week 12.

Daily diaries and capsule counts: to monitor adherence.

The visit schedule is as follows:

Baseline (Visit 1): Screening, informed consent, eligibility check, cognitive testing, blood draw, product distribution, and diary instructions.

Week 4 (Visit 2): Product count, diary review, questionnaire.

Week 8 (Visit 3): Product count, diary review, questionnaire.

Week 12 (Visit 4): Cognitive testing, blood draw, questionnaire, product return, diary review.

Statistical analyses will compare changes in cognitive performance and BDNF levels between the Sabroxy™ and placebo groups.

This study will provide important information about the potential of Sabroxy™ to support memory and brain health in older adults with mild cognitive concerns.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

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

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94132
        • San Francisco Research Institute

Participation Criteria

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

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy adults (male and female), 60 to 85 years old

Residing in independent living accommodation

Subjective reports of memory or cognitive impairment (answering "yes" to at least one of the following):

Do you feel your memory and thinking is getting worse?

Do you feel your memory and thinking has become worse over the past 2-3 years?

Are you concerned about your decline in memory and thinking?

Modified Montreal Cognitive Assessment (MoCA) score consistent with mild impairment

Non-smoker

Body Mass Index (BMI) between 18 and 35 kg/m²

No plans to commence new treatments over the study period

Understands and is willing to comply with study procedures

Provides signed and dated informed consent

Exclusion Criteria:

  • Diagnosis of dementia (per NIA/AA criteria)

Uncontrolled hypertension, cardiovascular disease (MI, angina, CHF), bleeding disorders, type I diabetes, glaucoma, renal/hepatic disease, pulmonary or significant GI disease, gallbladder/biliary disease, or neurodegenerative/neurological disease

Significant psychiatric disorder (schizophrenia, bipolar disorder, OCD, personality disorder)

History of stroke, seizures, or head injury with loss of consciousness

Moderate-to-severe depression or anxiety (per Depression, Anxiety, Stress Scale)

Regular use of anticoagulants, anticholinergics, acetylcholinesterase inhibitors, or steroids

Medication change in past 3 months or expected changes during study

Use of vitamins or herbal supplements that may affect cognition

Current or recent (12 months) illicit drug abuse

Alcohol intake >14 drinks/week

Significant surgery in the last year

Study Plan

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

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Sabroxy™ (Oroxylum indicum extract)
Consume one capsule twice daily, after a meal.
Dietary supplement: Sabroxy™ (Oroxylum indicum extract)
Sabroxy™ is a standardized extract derived from the bark of Oroxylum indicum. In this study, participants will receive Sabroxy™ in capsule form. Each capsule contains a fixed dose of the extract and will be administered orally at a regimen of one capsule twice daily after meals for 12 weeks. The supplement is provided in visually identical containers to maintain blinding and is compared to a placebo control. The intervention is designed to evaluate potential improvements in cognitive function, including memory, attention, and executive performance, as well as effects on circulating Brain-Derived Neurotrophic Factor (BDNF) levels.
Other Names:
  • Oroxylum indicum extract
  • Sabroxy™
Placebo Comparator: Placebo (Inactive capsule)
Consume one capsule twice daily, after a meal.
Other: Placebo
The placebo is an inert capsule formulated to be visually identical to the Sabroxy™ capsules in size, shape, color, and packaging. It contains inactive ingredients only, with no active botanical extract. The placebo will be administered orally at the same regimen as the active intervention: one capsule taken twice daily after meals for 12 weeks. The use of a placebo ensures blinding of participants and study staff, allowing accurate comparison of cognitive and biomarker outcomes between groups.
Other Names:
  • Inactive capsule
  • Look-alike capsule

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Montreal Cognitive Assessment (MoCA) total score
Time Frame: Baseline and Week 12
The Montreal Cognitive Assessment (MoCA) is a 30-point interviewer-administered test assessing memory, attention, visuospatial ability, language, and executive function. Scores range from 0 to 30, with higher scores indicating better cognitive function (a score ≥26 is generally considered normal). The mean change from baseline to Week 12 will be compared between the Sabroxy™ and placebo groups.
Baseline and Week 12
Change in COMPASS accuracy composite (percent correct)
Time Frame: Baseline and Week 12
The Computerized Mental Performance Assessment System (COMPASS) provides accuracy scores (% correct) across cognitive subtests (e.g., memory recognition, working memory). Composite accuracy is reported as the mean percentage correct across prespecified subtests. Scores range from 0% to 100%, with higher percentages indicating better accuracy/performance. The mean change from baseline to Week 12 will be compared between the Sabroxy™ and placebo groups.
Baseline and Week 12
Change in COMPASS mean reaction time (milliseconds)
Time Frame: Baseline and Week 12
The Computerized Mental Performance Assessment System (COMPASS) measures reaction time in milliseconds (ms) across attention and response tasks. Reaction time is a continuous measure (theoretical range: 0 ms to no fixed upper limit). Lower values indicate faster and therefore better performance. Results will be reported as mean milliseconds and mean change from baseline.
Baseline and Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Mild Cognitive Impairment Questionnaire (self-reported cognitive function) total score
Time Frame: Baseline, Week 4, Week 8, Week 12
The Mild Cognitive Impairment Questionnaire is a self-report tool where participants rate memory and thinking difficulties over the past 4 weeks. Responses are recorded on a 5-point Likert scale (1 = Never, 5 = Always) across multiple items. Scores are summed to generate a total score, with the minimum possible score = [lowest possible total, e.g., number of items × 1] and maximum = [number of items × 5]. Higher scores indicate worse self-reported cognitive function (greater impairment). Mean change from baseline to Weeks 4, 8, and 12 will be compared between Sabroxy™ and placebo groups.
Baseline, Week 4, Week 8, Week 12
Change in Brain-Derived Neurotrophic Factor (BDNF) Levels
Time Frame: Baseline and Week 12
Blood samples will be collected to measure serum BDNF levels. Mean change from baseline to Week 12 will be compared between Sabroxy™ and placebo groups.
Baseline and Week 12
Compliance with investigational product by capsule count
Time Frame: Week 4, Week 8, Week 12

Compliance will be assessed by counting returned capsules at each visit. Compliance percentage will be calculated as:

(number of capsules actually taken ÷ number of capsules expected to be taken) × 100(number of capsules actually taken ÷ number of capsules expected to be taken) × 100(number of capsules actually taken ÷ number of capsules expected to be taken)×100. The mean compliance percentage will be compared across groups. Unit of Measure: Percent (%)
Week 4, Week 8, Week 12
Incidence of Treatment-Emergent Adverse Events (AEs)
Time Frame: Baseline through Week 12
Safety will be assessed by recording all treatment-emergent adverse events reported or observed from baseline through Week 12. Results will be reported as the number and percentage of participants experiencing at least one AE.
Baseline through Week 12
Compliance with investigational product by daily diary review
Time Frame: Week 4, Week 8, Week 12

Compliance will also be assessed by reviewing participant daily diaries documenting capsule intake. Compliance percentage will be calculated as:

(number of days capsule intake recorded ÷ number of days expected)×100(number of days capsule intake recorded ÷ number of days expected) × 100(number of days capsule intake recorded ÷ number of days expected)×100.

The mean compliance percentage will be compared across groups. Unit of Measure: Percent (%)
Week 4, Week 8, Week 12
Incidence of Serious Adverse Events (SAEs)
Time Frame: Baseline through Week 12
Serious adverse events will be recorded throughout the study. Results will be reported as the number and percentage of participants experiencing at least one SAE. Unit of Measure: Number of participants.
Baseline through Week 12
Incidence of Participant-Reported Side Effects
Time Frame: Baseline through Week 12
Tolerability will be assessed through participant-reported side effects, captured via direct questioning and diary review. Results will be reported as the number and percentage of participants reporting at least one side effect. Unit of Measure: Number of participants.
Baseline through Week 12
Number of Discontinuations Due to Adverse Events
Time Frame: Baseline through Week 12

The number of participants who discontinue the study due to adverse events will be recorded and compared between treatment groups.

Unit of Measure: Number of participants
Baseline through Week 12

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
SF Research Institute, Inc.

Study record dates

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

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 2, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 8, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 8, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 24, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OTC2020-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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

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