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Clinical study to evaluate the Efficacy and safety of nutraceutical formulation in neurodegenerative diseases linked to cognitive impairment

A Clinical study to evaluate the efficacy and safety of nutraceutical formulation in neurodegenerative diseases linked to cognitive impairment

Status
Recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/03/040964
Enrollment
60
Registered
2022-03-10
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

Health Condition 1: G300- Alzheimers disease with early onset

Interventions

None listed

Sponsors

CSIR
Lead Sponsor
RGGPG Ayurvedic College Paprola
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 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 4.The ability and willingness to provide informed consent.

Exclusion criteria

Exclusion criteria: 1.A screening MMSE score of 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.

Design outcomes

Primary

MeasureTime frame
Change in Mini-mental examination score from 1st day i.e. baseline to 12th week.Timepoint: 84 days

Secondary

MeasureTime frame
Change in SF-36 Health Survey score from 1st day i.e. baseline to 12th week.Timepoint: 12 weeks

Countries

India

Contacts

Public ContactDr Anjana Mishra

R.G.G.P.G ayu. College and hospital

dranjana269@gmail.com9418312324

Outcome results

None listed

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