Prevention and management of neurodegenerative disorders by an Ayurvedic formulation

Phase 3

Active, not recruiting

• Conditions: Mental Health, Neurodegenerative disorder,

• Registration Number: CTRI/2014/12/005312
• Lead Sponsor: Department of Science Technology

Brief Summary

A randomized double-blind placebo and active controlled clinical trial will be performed in healthy elderly subjects and SDAT patients with age more than 60 years. The polyherbal test formulation along with a placebo will be given to healthy elderly subjects while the SDAT patients will receive either the test formulation containing extracts of Bacopa monnieri (whole plant), Hippophae rhamnoides (fruits) and Dioscorea bulbifera (bulbils) at a dose of 500mg or donepezil drug (comparator agent) at a dose of 10mg twice daily, for a period of 12 months. After every three months, cognitive function will be assessed as primary outcome measures by determining the MMSE score, DSS Score, Immediate and Delayed word recall, attention span, functional activity questionnaire and depression score. Further inflammatory markers and level of oxidative stress markers will be analyzed using standard biochemical tests

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-02
• Last Update Posted: 2020-11-21

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Willingness to give informed consent and a deterioration of memory along with at least three of the following five complaints: 1.Poor orientation 2.Poor judgement and problem solving difficulties 3.Trouble in the functioning of community affairs 4.
• Inability to function independently in home and during hobbies 5.
• Difficulties in personal care.
• Clinical screening for SDAT was done using dementia rating scale-II.

Exclusion Criteria

Subjects suffering from any metabolic disease Established neuropathy or tuberculosis SDAT patients receiving conventional treatment were excluded from the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in cognitive function particularly memory performance including behavioral abnormalities	Gradual improvement (3,6,9 and 12 months)

Secondary Outcome Measures

Name	Time	Method
Effect on oxidative stress markers, anti-inflammatory activity, homocysteine lowering effects, improvement in attention span, new learning, orientation skill and improvement in sleep pattern	Gradual improvement (3,6,9 and 12 months)

Trial Locations

Locations (1)

Institute of Medical Sciences, Banaras Hindu University; 🇮🇳 Varanasi, UTTAR PRADESH, India

Institute of Medical Sciences, Banaras Hindu University

🇮🇳Varanasi, UTTAR PRADESH, India

Prof R G Singh

Principal investigator

9839080939

directorims@gmail.com