Clinical study to evaluate the Efficacy and safety of nutraceutical formulation in neurodegenerative diseases linked to cognitive impairment
- Conditions
- Health Condition 1: G300- Alzheimers disease with early onset
- Registration Number
- CTRI/2022/03/040964
- Lead Sponsor
- CSIR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1.Mild and moderate subjective symptoms of memory impairment.
2.Age of patient :50-80 years.
3.A previous diagnosis of early dementia or MCI with a score of >9 and <23 on the mini-mental state examination
4.The ability and willingness to provide informed consent.
1.A screening MMSE score of <9(indicating severe memory impairment.)
2.Known neuropsychiatric conditions.
3.Uncontrolled hypertension or diabetes mellitus.
4.Drug dependence or addiction.
5.Use of alcohol, psychotropic drugs or alternative
medicines for memory.
6.Subject with concurrent Hepatic dysfunction.
7.Subjects suffering from major systemic illness necessitating long term drug use (R.A.,T.B.)
8.Any other condition which the investigator thinks may compromise the safety.
9.Subjects with established diagnosis of CAD requiring any procedure in next 6 months -angioplasty or bypass surgery or any other clinically significant cardiovascular disease.
10.Already known hypersensitivity to any interventional drug.
11.Patients who have participated in any clinical trial during past 6 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Mini-mental examination score from 1st day i.e. baseline to 12th week.Timepoint: 84 days
- Secondary Outcome Measures
Name Time Method Change in SF-36 Health Survey score from 1st day i.e. baseline to 12th week.Timepoint: 12 weeks