Health Condition 1: F99-F99- Unspecified mental disorder
Conditions
Interventions
Intervention1: 10 % Oroxylin -A 250 mg and Bioperine 5 mg: One capsule twice a day for 90 days
Control Intervention1: Microcrystalline cellulose ( MCC) 250 mg: One capsule twice a day for 90 days
Sponsors
Sami Sabinsa Group Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 50 to 80 years ( male & female) both inclusive. 2. Mild cognitive impairment or early dementia patients with: - Complaints of memory which is reflected in everyday activities like difficulty in remembering names of individuals, misplacing objects, difficulty in remembering in multiple items to be purchased, difficulty in performing multiple tasks, difficulty in remembering telephone numbers, difficulty in recalling information. - Mini-Mental State Examination (MMSE) score greater than or equal to 18 and less than or equal to 23. - Montgomery – Asberg Depression Rating Scale (MADRS)score of less than or equal to 8 3. Patients whose functional performance and cognitive abilities are sufficiently preserved. 4. Stable general health with no additional diseases expected to interfere with the outcome of the study 5. Able to give written informed consent and comply with requirements of the trial. 6. Ability to swallow & retain the oral medications.
Exclusion criteria
Exclusion criteria: 1. Psychiatric with known neuropsychiatric conditions like Schizophrenia, Parkinsonism, Huntington’s disease, Picks disease etc. 2. History of alcoholism (inability to control drinking due to both physical and emotional dependence on alcohol characterized by uncontrolled drinking and preoccupation with alcohol) and drug addiction. 3. Patients taking any other drugs or alternative medicines for enhancement of memory 4. Patients with Vitamin B12 deficiency. 5. Patients with uncontrolled hypertension and diabetes mellitus 6. Pregnant and lactating women 7. History of major surgery within the past 6 months or any acute medical/surgical complications which require hospitalization. 8. Patients with a diagnostic history of clinically significant thyroid disorder (hypo or hyper), cardiovascular (congenital heart disease, cardiomyopathy, heart failure, valvular heart disease) haematological, hepatic, renal, respiratory, or genitourinary abnormalities or diseases or any clinical condition, according to the investigator which does not allow safe fulfilment of the study protocol. 9. A history of significant multiple and/or severe allergies or anaphylactic reactions. 10. Patients with known history of hypersensitivity to the investigational product. 11. Subject has participated in any clinical trial within last 3 months. 12. Any other condition which the Principal Investigator thinks may jeopardize the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To assess the efficacy of 10% Oroxylin – A, on memory improvement in the patients with, mild cognitive impairment or early dementia. a. Mean change in memory from visit 2 (Enrolment/Randomization) to Visit 5 (day 90) as assessed by Montreal Cognitive Assessment (MoCA).Timepoint: a. Dat 0 to day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety of 10% Oroxylin - A, in patients with mild cognitive impairment or early dementia. 1. Mean change in other cognitive abilities (at least by 20%) from visit 2 (Enrolment/Randomization) to Visit 5 (day 90) by MoCA assessment. 2. Mean change in MMSE 3. Mean change in Montgomery – Asberg Depression Rating Scale (MADRS) 4. To assess the safety of 10% Oroxylin – A, by occurrence of adverse event throughout the study period. 5. Biomarker results: BDNF levels in serumTimepoint: 1. Day 0 to Day 90 2. Screening to Day 90 3. screening to Visit 5 (Day 90) 4. screening to Visit 5 (Day 90). 5. Day 0 to Day 90 | — |
Countries
India
Contacts
Public ContactShaji Paulose
Sami-Sabinsa Group Ltd
Outcome results
None listed