Oroxylin-A, as a neuroprotector in improving memory in patients with MCI and early dementia.

Phase 3

Completed

Brief Summary: a) Male and female patients who meet all the Inclusion and none of the Exclusion criteria will be enrolled/randomised in the study.

b) Patients will be randomized and will be administered and advised to take either 10% Oroxylin-A 250 mg and Bioperine 5 mg or Placebo capsules, b.i.d. for a period of 90 days.

c) Patients will have to visit the study site on Screening (Day -5), Enrolment/Randomization Visit (Day 0), Visit 3 (Day 30) +/- 5 days, Visit 4 visit (Day 60) +/- 5 days, Visit 5/ final visit (Day 90) +/- 5 days.

d) Telephonic follow-up after 7th day till a maximum of 15th day of the last visit to know the overall wellbeing of the patients.

e) This study will provide an insight about 10% Oroxylin-A and its efficacy on memory enhancement and improvement in other cognitive abilities.

Recruitment & Eligibility

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 â€“ 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

Psychiatric with known neuropsychiatric conditions like Schizophrenia, Parkinsonism, Huntingtonâ€™s disease, Picks disease etc.
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.
Patients taking any other drugs or alternative medicines for enhancement of memory 4.
Patients with Vitamin B12 deficiency.
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.
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.
A history of significant multiple and/or severe allergies or anaphylactic reactions.
Patients with known history of hypersensitivity to the investigational product.
Subject has participated in any clinical trial within last 3 months.

Primary Outcome Measures

Name	Time	Method
a. Mean change in memory from visit 2 (Enrolment/Randomization) to Visit 5 (day 90) as assessed by Montreal Cognitive Assessment (MoCA).	a. Dat 0 to day 90
1. To assess the efficacy of 10% Oroxylin â€“ A, on memory improvement in the patients with, mild cognitive impairment or early dementia.	a. Dat 0 to day 90

Secondary Outcome Measures

Name	Time	Method
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.

Locations (3): Ahana Hospital
🇮🇳
Madurai, TAMIL NADU, India
Apollo First Med Hospitals
🇮🇳
Madurai, TAMIL NADU, India
Elite Mission Hospital
🇮🇳
Thrissur, KERALA, India
Ahana Hospital
🇮🇳Madurai, TAMIL NADU, India
Dr Vikhram Ramasubramanian
Principal investigator
9443772233
vikhram@ahanahospitals.in