To Evaluate the Efficacy and Safety of Berberis aristata in Adult Human Subjects who are suffering from Mild Cognitive Impairment
- Conditions
- Health Condition 1: F068- Other specified mental disorders due to known physiological condition
- Registration Number
- CTRI/2022/08/045067
- Lead Sponsor
- Omniactive Health Technologies Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Adult male/female human participants of � 18 and �55 years of age.
2.Participants with BMI � 18.5 kg/m2 and � 29.9 kg/m2.
3.Participants with Mini-Mental State Examination (MMSE) score 19 to 26 indicating mild cognitive impairment.
4.Participants who agree to maintain their usual dietary habits throughout the trial period.
5.Participants who agree to maintain their usual level of activity, i.e., maintain their usual lifestyle throughout the trial period.
1.Participants Ã?â?? 18 or Ã?Æ? 55 years of age.
2.Participants having hypersensitivity or history of allergy to the study product or any of its ingredients.
3.Participants suffering from moderate to severe fatigue or having chronic fatigue syndrome.
4.Participants suffering from 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 collection.
5.Participants suffering from a metabolic disorder (uncontrolled diabetes, uncontrolled thyroidal condition) and/or from severe chronic disease (cancer, renal failure, HIV, immunodeficiency, hepatic or biliary disorders, arthritis, uncontrolled cardiac disease) or from a disease found to be inconsistent with the conduct of the study by the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method