CTRI/2025/01/079046
Not yet recruiting
Phase 3 4
A Prospective, Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety and Efficacy of BG-25 on Cognitive Functions - Implications for Academic and Professional Performance
Akay Natural Ingredients Pvt. Ltd.1 site in 1 country110 target enrollmentStarted: January 30, 2025Last updated:
Overview
- Phase
- Phase 3 4
- Status
- Not yet recruiting
- Sponsor
- Akay Natural Ingredients Pvt. Ltd.
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- To evaluate the effects of BG-25, as compared to placebo, on memory,learning and cognitive performance.
Overview
Brief Summary
This is a randomized, double-blind, placebo-controlled, parallel group, clinical interventional study. Adult healthy males and/or females, students, working professionals, meeting all inclusion and no exclusion criteria will be enrolled in the study after signing a written informed consent. After the informed consent process, demographic details will be obtained. Eligible subjects will be randomized into one of the treatment arms (1:1) as per randomization schedule for a treatment period of 56 days (8 weeks) and post-treatment follow-up period of 28 days (total of 12 weeks). Efficacy assessments will include all the measures required for the primary objective and secondary objectives of the study. A subject diary shall be provided to the subjects to record the study product administration, AEs and concomitant medications details during the study duration. Any additional and missed administrations should also be noted in the subject diary. Subject diary shall be used to evaluate study product administration compliance.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •1.Male and female subjects who are students or working-class professionals 2.Subjects with BMI of 18.5 kg per meter square to 29.9 kg per meter square 3.Subjects with Mini-Mental State Examination (MMSE) score greater than 24 and Hamilton Rating Scale for Depression (HAM-D) score less than 7 4.Subjects who agree to maintain their usual dietary habits and level of exercise i.e. maintain their usual life-style throughout the trial period 5.Subjects willing to refrain from taking any medications or preparations to improve fatigue during the study 6.Subjects willing to refrain from consuming alcohol 24 hours prior to the visit days 7.Subjects willing to refrain from consuming caffeine and caffeine-containing products 12 hour prior to visit days.Subjects willing to refrain from vigorous physical activity 12 hours prior to visit days.9.Females of childbearing age, agree to use approved birth control methods during the study, and have negative UPT at screening 10.Subjects fluent in English language 11.Subjects with basic computer literacy and exposure to computerized tests.12.Subjects willing and able to give informed consent and comply with the study procedures.13.Subjects willing and able to understand and comply with the requirements of the study, consume the study IP as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study.
Exclusion Criteria
- •1.Subjects who are on consumption of any cognition, energy and mood improving medicines, alcohol, tobacco, or any other Central Nervous System (CNS) acting medicines.2.Subjects having hypersensitivity or history of allergy to the study product.3.Subjects with moderate to severe fatigue or having chronic fatigue syndrome.4.Subjects with a malignant disease or any concomitant end-state organ disease and or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection5.Subjects suffering from a metabolic disorder (uncontrolled diabetes, uncontrolled thyroidal condition) and/or from severe chronic disease or from a disease found to be inconsistent with the conduct of the study by the investigator.6.Subjects with a psychiatric diagnosis other than anxiety or depression.7.Subjects with sleep disturbances and/or are taking sleep aid medication.8.Subjects with uncontrolled hypertension at screening.9.Subjects who are on anxiolytics, anti-depressants, antipsychotics, anticonvulsants, antihypertensive, centrally acting corticosteroids, opioid pain relievers, hypnotics, and or prescribed sleep medications.10.Subjects with a history of drug and or alcohol abuse at the time of enrolment.11.Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.12.Subjects with positive UPT at Screening or Randomization Visit.13.Subjects who have been treated with any investigational drug or investigational device within a period of 3 months prior to study entry.
- •14.Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
Outcomes
Primary Outcomes
To evaluate the effects of BG-25, as compared to placebo, on memory,learning and cognitive performance.
Time Frame: Baseline,Day 14, Day 28, Day 56, Day 84
Secondary Outcomes
- To evaluate the effects of BG-25, as compared to placebo, on biomarkers.(Baseline and Day 56)
- Overall Safety(Baseline and Day 56)
- To evaluate the effects of BG-25, as compared to placebo, on mindfulness.(Baseline, Day 56, Day 84)
Investigators
Dr Harshith C S
BGS Global Institute of Medical Sciences
Study Sites (1)
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