A Clinical trial to evaluate the safety and immunomodulatory efficacy of Byolic CC supplement compared to placebo in healthy adults

Safety evaluation of Byolic CC supplement compared to placebo in healthy adults Evaluation of immunomodulatory effect of Byolic CC supplement compared to placebo in healthy adults

The phase 1/2 Clinical trial with a control group, with parallel groups, double-blind, randomized, on 90 patients. The rand function of Excel software was used for randomization.

90 healthy volunteers are randomly divided into two groups of 45 people and take medicine or placebo for 2 months. Place of study: Shahed University Safety Response Regulation Research Center

Inclusion criteria: Health of volunteers Age range 15-60 years Exclusion criteria: cardiovascular, kidney, lung, liver, endocrine, hematological, neurological or psychiatric diseases, etc. taking immunosuppressive drugs, or any other drug (within 4 weeks before the start of the study) that may interfere with the supplement used in this study (or other herbal products) drug and food allergies pregnancy or lactation withdrawal criteria: Pregnancy during the study The need to take medication during the study

Intervention group: Healthy volunteers take Byolic CC capsules produced by Behpad Tab Company for 2 months, once a day, preferably with a meal. Placebo group: Healthy volunteers take placebo capsules for 2 months, once a day, preferably with a meal.

safety check variables: Physical examination, vital signs and laboratory measurements including blood biochemistry (BC) and complete blood count (CBC). Variables for investigating the immunomodulatory effect: Measuring the levels of cytokines TNF-a and IL-12 in serum samples by ELISA method Measuring the level of cytokine IFN-γ in the supernatant Measuring the proliferation and activation of NK cells by flow cytometry using FITC-a-human CD56 and PE-a-human CD314 (NKG2D) antibodies.

After the registration of healthy volunteers in the study, the subjects will be randomized into 2 groups using the randomization method based on random blocks. In this way, 2 blocks are formed by combining codes A and B, related to the drug and placebo groups. Then the blocks will be randomly selected based on the rand function from the Excel software until the final volume of the sample is reached. Grouping is done by determining 90 non-transparent envelopes that have the group number on the envelope and the type of intervention inside the envelope.

Both the drug and the placebo are packed in the same package and can only be identified by the code and in this way, blinding has been done for the patient, the plan executive, the clinical care provider, the outcome assessor and the data analyst. At the end, after the final analysis of the data, the codes will be opened.

After publishing the final results, the study protocol, statistical analyzes and the informed consent form will be shared without mentioning the names of the individuals.

Access starts 6 months after the results are published

Domestic researchers

To conduct review studies or advanced statistical analysis and bioinformatics

Project manager in coordination with Shahed University Research Center

Submitting a request to the executor of the project, Mrs. Dr. Mahlujirad,Referral to the head of the center Shahed University research, Obtain university approval,Provision of data