Evaluation of therapeutic effects of bacopa monnieri on neuropsychologic profile resulting from traumatic brain injury: a randomized, double-blind, placebo-controlled trial

Determining the effect of therapeutic effects of bacopa moneri on neuropsychological profile in patients with traumatic brain injury

A double blind randomized parallel clinical trial study

The studied community: One hundred (100) known traumatic brain injury patients Method: Standardized extract of B. monnieri 160 mg per day or a similar placebo tablet orally for 12 weeks is given to the participants. The degree of neuropsychological profile of the patients in three stages, before the start of the research, one month after the start of the research and after three months from the start of the research.

1. Sign the written consent 2. Patients with known traumatic brain injury according to the opinion of the attending physician 3. Incidence of dementia caused by traumatic brain injury based on Eden Brook index score 4. Age 18 to 65 years 5. Not suffering from dementia or Alzheimer's disease before brain trauma 6. A minimum of two weeks and a maximum of one year have passed since the occurrence of brain trauma. 7. 6 Not taking antidepressants including SSRI, SNRI, TCA, MOAI 8. 5. Absence of pregnancy, breastfeeding 9. No previous history of dementia 10. Not suffering from hypothyroidism 11. No kidney problems 12. No liver problems 13. Absence of heart disease/bradycardia/arrhythmia 14. Not suffering from serious metabolic disease 15. Not suffering from severe depression 16. Non-contradiction of Bacopa drug 17. No history of covid affecting memory 18. Not taking drugs that may cause cognitive impairment, such as topiramate, anticholinergics

The intervention group with Acopa Muniri and the control group with placebo

Degree of neuropsychological profile

Permuted block randomization method is used to create a random sequence (Random sequence generation) in order to create a balance in the number of samples assigned to each of the studied groups. In this study, 25 blocks of 4 will be considered. Random code generation is generated with the help of http://www.randomization.com. Using the table generated by the random assignment site, each patient is allocated to the treatment or placebo group. After the consent of the person to participate, each person is given a number from 1 to 100. Then, by another person, depending on the patient number, a letter A or B will be installed on the medicine packages of one shape, and thus they will be allocated in intervention groups.

In this study, the participants and those who evaluate the desired outcomes are blinded. For blinding and in order to make the placebo pills as similar as possible to the original pills, the size and shape of the pill is tried to be modeled on the original pill. The weight of the manufactured tablets will be almost equal to the original tablet, with a hardness of 3 to 5 kg and a time of less than 15 minutes. Also, the sequence of random allocation of people is kept secret.