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Assessment of Efficacy & Safety of Stadice for Enhancement of Cognitive Abilities

Assessment of Efficacy & Safety of Stadice for Enhancement of Cognitive Abilities- A Double Blinded Placebo Controlled Randomized Trial with Concurrent Parallel Design - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/08/056109
Enrollment
60
Registered
2023-08-03
Start date
Unknown
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Stadice®: Route of Administration: Oral dosage Quantity: Stadice 300 mg Placebo 300 mg Once a day treatment period: 7 days Control Intervention1: Not Applicable: Not Applicable

Sponsors

Zeushygia Lifesciences Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Participants must self-assess themselves as being in good health. 2. Participants must be regular virtual/mobile/computer/laptop game players or E-game players. 3. Aged 18 to 45 years of both male and female at the time of giving consent.

Exclusion criteria

Exclusion criteria: Subjects meeting any of the following criteria will be excluded from the study: 1. Have high blood pressure (systolic over 159 mm Hg or diastolic over 99 mm Hg) 2. Have a Body Mass Index (BMI) outside of the range 18.5-35 kg/m2. 3. Are pregnant, seeking to become pregnant or lactating. 4. Have learning and/or behavioral difficulties such as dyslexia or ADHD. 5. Have a visual impairment that cannot be corrected with glasses or contact lenses (including color-blindness) 6. Smoke tobacco or vape nicotine or use nicotine replacement products >2 times per day. 7. Excessive caffeine intake ( >500 mg per day) 8. Have taken antibiotics or dietary supplements e.g., Vitamins, omega 3 fish oils etc. in the last 4 weeks (Note: participation is possible following a 4-week supplement washout prior to participating and for the duration of the study) 9. Are currently participating in other clinical or nutrition intervention studies or have in the past 4 weeks. 10. Has been diagnosed with/ undergoing treatment for alcohol or drug abuse in the last 01 month. 11. Have been diagnosed with/ undergoing treatment for a psychiatric disorder in the last 01 month. 12. Suffers from frequent migraines that require medication (more than or equal to 1 per month) 13. sleep disorders or are taking sleep aid medication. 14. Are non-compliant with regards treatment consumption 15. An inability to speak with study personnel via Zoom or do not have a private area to perform the study activities

Design outcomes

Primary

MeasureTime frame
Cognitive domain - Definition - Test 1. Mood - Measurement of subjective feelings - Bond &Lader Mood Scales 2.Attention & Vigilance -Attention-Ability to concentrate on selected aspects of environment & Vigilance - Simple Reaction Time 3.Executive function - Cognitive Responses - Stroop Test 4.Episodic Memory - Ability to retain memories - Delayed & immediate word recall 5.Working Memory - Ability to retain information - Corsi Block test 6. Location learning - Visual Memory - Computerized location learning & Recall Timepoint: Day 1 & DAY 7

Secondary

MeasureTime frame
1.Psychological stress response. Modulation of the psychological response to acute stress (change in: Stress on the afore mentioned mood measures during the OMS) as a consequence of the OMS. 2.Mood measures- State Trait Anxiety Inventory (STAI). (20-80; higher is more anxious) POMS shall be used to identify the baseline of Mood measures- Profile of Mood States (POMS)1 3.Cognitive Function- Individual task Physiological stress response- Adrenaline Blood Markers i.e., plasma Cortisol taken baseline & end of study in both periods (50% subjects).Timepoint: Day 1 & Day 7

Countries

India

Contacts

Public ContactMeena Dalal

Maayra Emotional Wellness Center

kanzal.maayra@gmail.com6360804814

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026