Evaluation of the Effect of Capsule Ascorbic Acid (Vitamin C) on Premenstrual Syndrome

Determining the effect of vitamin C capsules on premenstrual syndrome

A clinical trial with a control group, with a parallel group, three-blind, randomized with software, phase 3, on 80 patients

In this study, Shahid Beheshti University of Medical Sciences dormitory students after filling the Beck depression test and having 5 symptoms of the temporary diagnosis questionnaire of premenstrual syndrome taken from the Diagnostic and Statistical Manual of Mental Disorders 5 (DSM V) for 2 consecutive months, they will complete the form for recording the daily condition of premenstrual syndrome symptoms taken from DSM V, and after the definitive diagnosis of the syndrome, they will be randomly divided into two groups and treated with ascorbic acid capsules or placebo for 2 consecutive months. will be placed. In this three-way blind study, the participants, the researcher, and the data monitoring committee did not know the type of drugs, and for blinding, the coding of the drugs by the pharmacist will be used

Inclusion: dormitory resident, willingness to participate in the study, single, age range 18 to 40 years, normal body mass index, regular menstruation and normal cycle length, non-smoking, exclusion conditions: not suffering from physical illness (diabetes, hypothyroidism, etc.) and known mental illness, not taking anti-depressants, hormonal, herbal, thyroid and prolactin disorders, no history of any type of surgery

Intervention group: 500 milligram Vitamin C, one daily from the 21st day of menstruation to the 5th day of the next cycle for 2 consecutive months, made in the Faculty of Pharmacy of Shahid Beheshti University; Control group: the conditions of the intervention group with placebo replacement

Symptoms of premenstrual syndrome and severity of symptoms

In this study, the sampling method is available, but the allocation of samples will be simple random using the function of random numbers. The randomization using Excel software is as follows: First, in a column, groups are entered as A and B below. In the opposite column, random numbers are generated using the RAND command. In the next step, using the sort command, the generated random numbers are sorted from small to large or vice versa, which changes the order of the groups, namely A and B. Using the new arrangement, people are assigned to different groups. Then each number is written on a card and placed in an envelope. The envelopes are sealed and the number of people with syndrome is recorded on each envelope, and the first person enrolled in the study will be given envelope number 1 and the second person will be given envelope number 2, and so on. This will be done until the end of the sample size.

This study is a three-blind clinical trial with a placebo control group. For the purpose of blinding, the sample units will be informed that the presence of people in the intervention and control groups is equal. Therefore, if they wish, people will enter the study and will not know the type of drug used. The researcher and the analyst of the results do not know the type of drugs and for blinding, the coding of the drugs will be used by the pharmacist