Study of Ashwagandha (Withania somnifera) in mild memory impairment

Phase 4

Completed

• Registration Number: CTRI/2016/10/007354
• Lead Sponsor: Shri Kartikeya Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

1.Adult male or female patients aged greater than 35 years of age

2.Patients with early dementia or mild cognitive impairment

3.Have a screening Mini-Mental State Examination (MMSE) score of greater than or equal to 19 (mild or no memory impairment)

4.Patients with subjective memory complaints

5.Have the ability to understand the requirements of the study

6.Participants agree to abide by the study restrictions and return for the required assessments

7.Participants willing to sign informed consent

Exclusion Criteria

1 Have a screening Mini-Mental State Examination (MMSE) score of less than 19(moderate and severe memory impairment)

2.Psychiatric with known neuropsychiatric conditions like Schizophrenia, Parkinsonism, Huntingtonâ??s disease, Picks disease etc.

3.Patients taking psychotropic drugs including alcohol

4.Patients taking any other drugs or alternative medicines for enhancement of memory

5.Patients with known persistent endocrine disorders

6.Patients with uncontrolled hypertension

7.Patients with uncontrolled diabetes mellitus

8.H/o of drug dependence or any severe co-morbid medical conditions

9.Pregnant and lactating women

10.Subjects with known hypersensitivity to Ashwagandha

11.History of major surgery within the past 6 months

12.Participation in other clinical trials during previous 3 months

13.Any clinical condition, according to the investigator which does not allow safe fulfillment of the study protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified