A Study of Sabroxy™ (Oroxylum Indicum Extract) for Improving Cognitive Function in Adults With Mild Memory Concerns
NCT ID: NCT07189754
Last Updated: 2025-09-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
70 participants
INTERVENTIONAL
2020-11-02
2021-02-08
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Sabroxy™ (Oroxylum indicum extract)
Consume one capsule twice daily, after a meal.
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.
Placebo (Inactive capsule)
Consume one capsule twice daily, after a meal.
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
60 Years
85 Years
ALL
Yes
Sponsors
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SF Research Institute, Inc.
NETWORK
Responsible Party
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Locations
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San Francisco Research Institute
San Francisco, California, United States
Countries
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Other Identifiers
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OTC2020-002
Identifier Type: -
Identifier Source: org_study_id
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