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A clinical study to evaluate the advanatges and safety of long term CurQfen consumption in dementia patients

Not Applicable
Completed
Conditions
Health Condition 1: null- Dementia
Registration Number
CTRI/2018/03/012410
Lead Sponsor
Akay Flavours and Aromatics Private Limited
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
48
Inclusion Criteria

1. Age 55-75 Years ( Both Inclusive)

2.Male and Female Subjects

3.Patients with a MMSE Score Less than 26 and More than 14 (Both are Inclusive)

4.Must have a caregiver to attend the study visit.

5.Informed consent from Subject and Legally acceptable Representative-LAR( LAR can be Spouse/Parent/Son/Daughter/Guardian/Person Having charge or any other legally acceptable Representative)

Exclusion Criteria

1.Severe Memory Loss

2.Stroke

3.Psychiatric illness

4.Subjects who are under the treatment with anti Inflammatory Drugs

5.Objection from family members or any other close relatives or Legally acceptable representatives

6.If the participation in the study cause any harm to possible benefits to the patients, including Insurance benefits.

7.Objection from the Physician, under whom, current treatment is going on.

8.Patients, who are in the Clinicians judgment, are like to be placed in a nursing home, within next 6 months

9.Any condition that in Opinion of the Investigator, does not justify the Subjectsâ?? participation in the study.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Comparative changes in the MMSE, ACE-R, QOL,Beta Amyloid scores from baseline to Day 180.Timepoint: Day 0,Day 90,Day 180
Secondary Outcome Measures
NameTimeMethod
Comparative changes in the anti oxidant, anti inflammatory and safety parameters from Day 0 To day 180Timepoint: Day 0. Day 90, Day 180
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