Study of Ashwagandha (Withania somnifera) in mild memory impairment

Efficacy And Safety Of KSM66 Ashwagandha (Withania somnifera) In Cognitive Function In Healthy Adults: A prospective, Randomized, Double blind, Placebo controlled Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/10/007354

Enrollment

Registered

2016-10-13

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Capsule containing KSM-66 (Withania somnifera): One capsule twice daily orally for 8 weeks Control Intervention1: Capsule containing Placebo: Placebo capsule identical to KSM 66 (Witha

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Improvement from baseline in the composite score of Wechsler Memory Scale III (WMS-III) after therapyTimepoint: 8 weeks	—

Secondary

Measure	Time frame
Improvement from baseline in the Index scores of General memory after therapy.Timepoint: 8 weeks;Improvement from baseline in the Index scores of immediate memory after therapy.Timepoint: 8 weeks;Improvement from baseline in the Index scores of working memory after therapy.Timepoint: 8 weeks;Improvement from baseline in the score of Eriksen Flanker task after therapyTimepoint: 8 weeks;Improvement from baseline in the score of Mackworthâ??s sustained attention test after therapyTimepoint: 8 weeks;Improvement from baseline in the score of Shepardâ??s mental rotation task after therapyTimepoint: 8 weeks;Improvement from baseline in the score of Trail making test part A after therapyTimepoint: 8 weeks;Improvement from baseline in the score of Wisconsin card sort test after therapyTimepoint: 8 weeks;Improvement from baseline in the scores of visual reproduction I and II total score, visual reproduction II Recognition Total Score, visual reproduction II Copy Total Score and visual reproduction II discrimination Total Score after therapyTimepoint: 8 weeks	—

Measure

Time frame

Improvement from baseline in the Index scores of General memory after therapy.Timepoint: 8 weeks;Improvement from baseline in the Index scores of immediate memory after therapy.Timepoint: 8 weeks;Improvement from baseline in the Index scores of working memory after therapy.Timepoint: 8 weeks;Improvement from baseline in the score of Eriksen Flanker task after therapyTimepoint: 8 weeks;Improvement from baseline in the score of Mackworthâ??s sustained attention test after therapyTimepoint: 8 weeks;Improvement from baseline in the score of Shepardâ??s mental rotation task after therapyTimepoint: 8 weeks;Improvement from baseline in the score of Trail making test part A after therapyTimepoint: 8 weeks;Improvement from baseline in the score of Wisconsin card sort test after therapyTimepoint: 8 weeks;Improvement from baseline in the scores of visual reproduction I and II total score, visual reproduction II Recognition Total Score, visual reproduction II Copy Total Score and visual reproduction II discrimination Total Score after therapyTimepoint: 8 weeks

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Countries

India

Contacts

Public ContactDr Dnyanraj Choudhary

Atur Sangtani

dr.dnyanrajc@yahoo.co.in9823217423

Outcome results