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Treatment of Nisyan (Amnesia) with Unani medicine Majun Boolus

Phase 3
Conditions
Health Condition 1: R411- Anterograde amnesia
Registration Number
CTRI/2021/07/034593
Lead Sponsor
Central Council for Research in Unani Medicine CCRUM New Delhi
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

The patients fulfilling the following inclusion criteria will be included in this study:

1. Subjects of either sex in the age group 40-80 years.

2. Subjects with MMSE score of 10-23 representing mild to moderate cognitive impairment.

Exclusion Criteria

1. Clinical presentation and/or history of any significant organic neurological diseases including space occupying lesions, stroke, head injury, seizure, and mental retardation

2. Subjects with impairment of speech, hearing and vision, which can impede the interview for MMSE and QOL assessment

3. Known cases of hypothyroidism or hyperthyroidism

4. Subjects with Vitamin B12 deficiency

5. Subjects on Psychotropic Drugs

6. Clinical presentation and/or history of a chronic disease that requires long-term treatment, e.g., DM, tuberculosis, HIV infection, syphilis, CVD, pulmonary disease, CKD, chronic liver disease, or any other serious and/or unstable medical condition that, in the opinion of the investigator, could expose the patients to undue risk of a significant adverse event or interfere with assessment of safety or efficacy during the course of the trial

7. Pregnant and lactating females

8. H/o Addiction (alcohol, drugs)

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Improvement in sign and symptoms of Nisyan (Amnesia)Timepoint: The patients will be assessed at every 2 weeks. The total duration of treatment is 12 weeks. <br/ ><br>The results of the study will be recorded in terms of percentage efficacy as calculated from enhancement in the mini-mental status examination (MMSE) score and improvement in Quality of Life (QOL).
Secondary Outcome Measures
NameTimeMethod
Haematological and biochemical assessment for safety assessmentTimepoint: 12weeks
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