Effect of Medhasagar rasa in age related Psychological Disorder

Phase 2

Completed

• Conditions: Health Condition 1: G318- Other specified degenerative diseases of nervous system

• Registration Number: CTRI/2022/12/047965
• Lead Sponsor: M/S Shree Dhootpapeshwar Limited, Mumbai

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-09-15
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1.Age between 50 -70 years of either sex.

2.Diagnosed as Mild Neurocognitive Disorder as per DSM V criteria {Possible sub types of Alzheimer’s disease, Frontotemporal lobar degeneration, Lewy body disease, vascular disease}.

3.Monteral cognitive assessment scale (MOCA) score between 18 and 25

Exclusion Criteria

1.Other Neuro cognitive disorders due to Parkinson’s disease, trauma, medical conditions etc.

2.Neuropsychiatric disorders such as Schizophrenia, Bipolar disorder, Major depressive disorder

3.Patients with severe or uncontrolled Diabetes mellitus Hypertension and Thyroid disorders.

4.Patients with clinically relevant depression.

[ Cornell Scale for Depression in Dementia (CSDD) >10].

5.Patient on any other medications like psychotropic, neurotropic etc since 4 weeks.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effect of Medhasagar rasa on cognitive assessment, functional assessment and quality of life in age related mild neurocognitive disorder as assessed on Manasabhava scale, Montreal cognitive assessment scale and Brief Cognitive rating scaleTimepoint: Baseline, Day 15, Day 30, Day 45, Day 60

Secondary Outcome Measures

Name	Time	Method
1.Effect of Medhasagar rasa in the improvement in severity of the disease as assesssed on Clinical global impression scale and improvement in anxiety and sleep quality as assessed on Hamilton Anxiety scale and Pittsburg sleep quality index respectively. <br/ ><br>2.Safety profile of Medhasagar rasa on Liver function (SGOT, SGPT) and Renal function (S.Urea, S.Creatinine).Timepoint: Day 0, 15, 30, 45, 60.