"Examining the Effectiveness and Side Effects of Softgel-Encapsulated IMOD in Individuals Living with HIV"

Examining the effectiveness of oral medication IMOD in improving immunological and virological indices in HIV-positive patients

A randomized, controlled clinical trial, with parallel groups, phase 3, on 120 patients, double-blind. Randomization will be done using the block method.

Patients with positive HIV who visit the infectious diseases department of Imam Khomeini Hospital in Tehran, will be divided into two groups. One group will receive intervention treatment with oral medication IMOD in the form of a gel, equivalent to 120 milligrams of pure extract, along with antiretroviral therapy. The other group will be the control group and receive treatment with antiretroviral drugs. Patients in both groups will undergo treatment for a period of 3 months. Participation in this project is voluntary, meaning that patients must volunteer themselves to participate. To better evaluate the therapeutic effects and side effects of this medication, patients in the intervention group will be assessed before and after the treatment, and the results of the intervention and control groups will be compared.

6Inclusion criteria: Written informed consent; Age between 18 and 65 years; Positive results for two HIV ELISA tests and one Western blot test. Exclusion criteria: Patients with hepatitis B or C; Pregnancy and lactation; Current substance abuse or alcohol consumption; Use of growth hormone within 30 days before study entry; Using testosterone or anabolic steroids (30 days before entering the study); long-term treatment with immunosuppressive drugs (except topical steroids); Chemotherapy, interferon treatment or radiotherapy (three weeks before entering the study).

Intervention group: oral medication IMOD in the form of a gel. Control group: receiving treatment with antiretroviral drugs.

CBC; ALK phos; AST/ALT; BUN; Cr; FBS; Viral load; CD4 count; Drug side effects.

In this study, randomization and allocation of patients into intervention and control groups are performed using a random block design. This method involves using a table of random blocks, where each block has an equal size, and within each block, random allocation of patients to the groups takes place. The steps for implementing randomization using a random block design are as follows: Determine the block size: In this step, the number of patients to be included in each block is determined. For example, if we want each block to consist of 4 patients, the block size would be 4. Create the blocks: Based on the total number of patients (in this case, 120 patients), the necessary blocks for allocating patients to the groups are created. For example, if we consider the total number of patients as 120 and each block to have 4 patients, then 30 blocks will be created. Randomly allocate patients: Within each block, patients are randomly allocated to the intervention and control groups. For this purpose, simple randomization methods such as using a random number table, computational software, or other randomization techniques are employed. By conducting this random allocation, each patient will have an equal chance of being assigned to either group, ensuring the balance and randomness of patient allocation. Therefore, the random block design provides a straightforward approach to achieve randomization and allocation of patients in a controlled manner, enhancing the validity and reliability of the study results.

Patients were allocated to the two groups through the block randomization table, but neither the person responsible for drug administration nor the patients themselves were aware of which group received the IMOD medication and which group received the placebo. This information was kept completely concealed from them. To maintain blinding, the drugs were designed to have similar shapes and colors, as coordinated, so that patients and the person responsible for drug administration would not be able to distinguish between the IMOD medication and the placebo. Throughout the study period, all patients were examined and assessed for clinical symptoms related to HIV and drug-related side effects. These evaluations aimed to identify and record drug-related adverse events and clinical symptoms associated with the disease in both groups. This approach ensured the preservation of double-blindness in the study and the unbiased nature of the results, independent of the knowledge and diagnosis of the individuals and patients."