NCT07189754

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: SF Research Institute, Inc. · Network
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Accepted

Summary

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.

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.

Conditions

• Mild Cognitive Impairment (MCI)
• Cognitive Dysfunction, Cognitive Disorder
• Memory Problems

Interventions

Type	Name	Description
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	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.

Timeline

• Start date: 2020-11-02
• Primary completion: 2021-02-08
• Completion: 2021-02-08
• First posted: 2025-09-24
• Last updated: 2025-09-24

Locations

1 site across 1 country: United States