The effect of Bacopa monnieri extract on cognitive function and sleep quality in patients with mild cognitive impairment: a triple-blind clinical trial study

Determining the effect of Bacopa monnieri extract on cognitive function and sleep quality in patients with mild cognitive impairment (MCI).

The study is a three-blind clinical trial (randomized control). The number of samples is 62. Using stratified random blocking method to identify groups in terms of gender (female / male),literacy level (diploma /undergraduate) and age (50-65 65<) are divided into two groups (intervention and control) Will take. Medications will be placed separately in A-B packages.

The present study is a triple-blind clinical trial (randomized controlled trial) (blind patient, blind physician and data analyzer). According to the mentioned inclusion criteria, patients with MCI referred to the office of the project partner who score < 26 in the MOCA Test will enter the study after obtaining the informed consent of the patients.

1. Conscious written consent 2. No psychiatric, gastrointestinal and kidney diseases 3. Have a minimum literacy 4. Score less than 26 on the MOCA 5. Not participating in another clinical trial during the past 2 months prior to the start of this study and other complementary medicine and cognitive rehabilitation programs 6. Do not take antidepressants, anticonvulsants, hypnotics and muscle relaxants according to self-declaration 7- Have at least two vascular risk factors such as: hypertension, diabetes, Hyperlipidemia, obesity and consumption have tobacco 8. Age: 50 years<

The intervention group was given 160 mg capsules of Bacopa dry extract orally twice a day for two months .The control group is given a placebo (containing the same starch as the main drug).

In this study, the primary outcome of the study of cognitive function and the secondary outcome is the study of sleep quality.

The present study is a triple-blind clinical trial (randomized controlled trial) (blind patient, blind physician and blind data analyzer). The randomization method is Stratified Random allocation. Its randomization unit is random blocks. Random layers including: gender, literacy and class age based on these variables as described by men / women, literacy level: diploma / undergraduate, age: 50 to 65.65 and above (50 to 65.65 and above) in two group (intervention and control) will be located. Randomization tool and how to create a random sequence: R software is a "blockrand" package.

The drugs will be placed separately in A-B packages. Participants and the whole research group are unaware of the final stage of extracting the final information from the contents of the envelopes ( A-B ), so the present study will be done in triple-blind.