A pilot study to evaluate the safety and advantages of CurQfen on brain function in middle aged to elderly people.

Completed

Brief Summary: This is a Single Centre Open Label Clinical study. The main purpose of the study is to prove the efficacy of CurQfen on Brain Function.

Helathy subjects are enrolled to participate in the study. Informed consent is obtained before undertaking any study related procedures. Subjects with a MMSE score greater or equal to 25 are enrolled in the study. The subjects visited their designated study site on following 4 different occasions:

Screening

Baseline : Day 0

Visit 3 : Day 15

Visist 4 : Day 30

Efficay and safety is established by comparing the end of study values with baseline values..

V

Recruitment & Eligibility

Inclusion Criteria

1)Age 35-65 Years ( Both Inclusive) 2)Male and Female Subjects 3)Subjects in general good health.
4)Subjects with a MMSE score between 25 â€“ 30.

Exclusion Criteria

EXCLUSION CRITERIA 1)Subjects with a education qualification less than higher secondary level 2)Subjects who are not familiar with computer/internet use.
3)Subject with dementia/related memory loss illness 4)Subjects diagnosed with learning difficulty such as dyslexia or dyspraxia 5)Suffering from any form of clinically diagnosed disease, including: oMajor mental illness (current or previous episode with hospitalization) oChronic fatigue syndrome oLiver disease oDiabetes mellitus oHeart disease or myocardial infarction ounderwent brain surgery owho have a central nervous system illness oneurological lesion 6)Subjects with a known allergy to herbal products 7)Subjects with abnormal biochemical or haematological values 8)Subjects with abnormal blood pressure 9)Pregnant or Lactating Women 10)Any condition that in Opinion of the Investigator, does not justify the Subjectsâ€™ participation in the study.

Primary Outcome Measures

Name	Time	Method
- Comparative changes EEG in basline and after administration of CurQfen	Day 0, Day 15, Day 30
-Comparative changes in cognitive assessment test scores	Day 0, Day 15, Day 30

Secondary Outcome Measures

Name	Time	Method
- Change in Brain Derived Neurotrophic factor (BDNF)	- safety of CurQfen

Locations (1): Aman Hospital and Research Centre
🇮🇳
Vadodara, GUJARAT, India
Aman Hospital and Research Centre
🇮🇳Vadodara, GUJARAT, India
Dr Aman Khanna
Principal investigator
amankhanna11974@gmail.com