IRCT20180610040037N5 IRCT 2023-07-17 Tehran University of Medical Sciences A Study on the Efficacy and Side Effects of Softgel-Encapsulated IMOD in Individuals with HIV" "Examining the Effectiveness and Side Effects of Softgel-Encapsulated IMOD in Individuals Living with HIV" 2023-07-23 anticipated 120 Complete https://irct.ir/trial/70920 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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.". 3 +HIV. Intervention 1: Oral IMOD medication and antiretroviral therapy: The intervention group consists of 60 individuals who will receive treatment with oral IMOD medication containing a combination of Tanacetum vulgare, Rosa canina, and Urtica dioica extracts. The medication is manufactured by Zist- Arvand Pharmed Factory and is formulated in the form of a soft gel equivalent to 120 mg of pure extract. They will undergo antiretroviral therapy for a duration of 3 months. Intervention 2: Control group will receive antiretroviral drugs based on the treatment regimens recommended by the guidelines in Iran for a duration of 3 months. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The decision of non-disclosure or sharing of IPD should be examined and evaluated based on a series of factors and environmental conditions, and the final decision should be made in accordance with the public interest and patient rights.