Evaluating the efficacy of herbal preparation Ashwagandha (Withania somnifera (L.) Dunal) on disease severity in patients with mild to moderate Alzheimer's disease: A triple-blind clinical trial

The main objective: Determining the efficacy of herbal preparation Ashwagandha (Withania somnifera (L.) Dunal) on disease severity in patients with mild to moderate Alzheimer's: A triple-blind clinical trial

Clinical trial with a control group, with parallel groups, triple blind, randomized, phase 3 on 100 patients. Allocation of patients into two groups is using random block permutation method and in blocks of 4.

Filling out questionnaires and providing capsules to Alzheimer's patients in nursing homes and neurology clinics. The doctor, the patient and the statistical researcher do not know the type of contents of the capsule.

Inclusion criteria: Having informed consent for study participation, Having a CDR score less than or equal to 2, Having an ADAS-COG score higher than or equal to 12, Ability to participate in the study Non inclusion criteria: Inability to participate in the study, Inability to continue treatment, Presence of heart disease, Substance abuse and alcohol addiction, Taking anticoagulant drugs

To conduct the research, eligible patients with Alzheimer's are selected by a neurologist and entered into the study. ADAS-COG and CDR questionnaires are filled for each patient at the beginning of admission and at the end of every 4 weeks for three months. In the intervention group, capsules containing the processed plant of Ashwagandha root are used. The dosage of the drug is considered to be two capsules of 250 mg of plant extract every 12 hours for 3 months for each patient. In the placebo group, corn starch is used. The capsules used in both groups are similar in terms of shape, color and size. The minimum sample size in each group will be 50 people, trying to include mild and moderate types in two groups in equal proportion.

Reducing the severity of Alzheimer's

Patients are randomly assigned to one of the two groups of placebo and herbal medicine. Allocation of patients into two groups is using Permuted Block Randomization method and in blocks of 4. In this way, first, two codes 1 and 2 are randomly generated in blocks of 4 and each of these sequences of 4 are recorded in a sheet. Then, when conducting the study and entering the samples, one of the sheets will be randomly selected and 4 samples will be entered into group 1 or 2 in the order listed in the sheet.

After the preparation and standardization of the drug by the research team, the cans of the drug and placebo along with the label of how to use and a number as the drug code, are coded by the laboratory expert and given to the researcher. The doctor, the patient and the statistician are unaware of the type of medicine. The study is triple-blind, so that the person prescribing the drug does not know whether each code is related to the drug or a placebo. Also, the receiving person only realizes that the received drug is in code 1 or 2, and until the codes are broken, no one knows whether the received substance is a drug or a placebo. The codes related to the drug and placebo will only be in the possession of a member of the research team who has no connection with the patients and is solely responsible for coding and breaking the codes and will not have access to the sample information until the completion of the project.

There is no further information.