The Effect of epigallocatchin gallate Enriched Green Tea on some Clinical, Inflammatory, Antioxidant and Cognitive Parameters in Patients with Multiple Sclerosis; A Triple-blind Randomized Placebo Clinical Trial

Determining the effect of EGCG-enriched green tea on some clinical, inflammatory, antioxidant, and cognitive parameters and quality of life in patients with multiple sclerosis

A controlled, parallel-group, triple-blind, block-randomized clinical trial was conducted on 40 patients.

The target population of which was people with MS who referred to the Rafsanjan Center for Special Diseases. The three blind subjects: the patient, the researcher and the administrator, the examiner, and the data analyst were blinded to the medication used.

Inclusion criteria included willingness to participate in the study and having relapsing-remitting MS. Exclusion criteria included allergy to green tea or green tea components and products, use of any antioxidant supplements, daily consumption of green tea before the start of the study, following a special diet, participation in another study, alcohol consumption, drug and opium use, pregnancy and breastfeeding, neurological and autoimmune diseases, and cancer.

The subjects in the green tea and placebo groups consumed 2 capsules of EGCG-enriched green tea powder or placebo daily for 3 months while maintaining their usual diet. The dosage was 2 capsules daily, preferably one capsule every 12 hours. The selected dose was such that each subject received approximately 240 mg of the active ingredient EGCG (epigallocatechin gallate) daily.

Cognitive function: depression; fatigue; overt and covert anxiety; brief mental state; and auditory information processing speed and working memory.

Participants were randomly assigned to green tea and placebo groups using a 1:1 allocation ratio using a block randomization method. The randomization sequence was generated using SPSS software, and blocks of size 4 were used to maintain a balance between the numbers of subjects in the two groups throughout the study. In order to maintain allocation concealment, the allocation sequence was placed in sealed, numbered envelopes so that the assigned group could not be predicted when each participant entered the study.

Green tea and placebo capsules were delivered to the researcher in identical cans and packaging from Essans Daru Company. Only the numbers 1 and 2 were written on the cans of the capsules. None of the researchers, project managers, data analysts, outcome assessors, care provider, and participants (patients) knew which drug each number corresponded to. Data analysis was also performed in two groups, 2 and 1, and Essans Daru Company was asked about the type of drug when writing the results. In this study, the safety monitoring committee was not relevant.

The main consequence after de-identifying individuals is that they can be shared.

Access period begins one year after results are published.

Researchers working in academic and scientific institutions

For meta-analysis studies

Mahdieh Azin by email: mahdieh.azin@gmail.com

The application process must be formal, from an academic researcher. The purposes of using the data must be clearly explained. A reference to the published article must be provided.