Health Condition 1: R411- Anterograde amnesia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects of either sex in the age group 40-80 years 2. Individuals with subjective complaints of cognitive impairment 3. Subjects with MMSE score of 10-23 representing mild to moderate cognitive impairment
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The efficacy of the study drug in the treatment of mild to moderate Nisyan(Amnesia) will be assessed on the basis of improvement in the Mini Mental State Examination (MMSE) scoreTimepoint: At every 2 weeks for 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Haematological & biochemical assessment for safety assessment i.e. CBC, LFT, KFT, Urine Routine & microscopic examination.Timepoint: At baseline & 12 weeks | — |
Countries
India
Contacts
Central Council for Research in Unani Medicine (CCRUM)