The Effect of Melissa Officinalis Capsules and Health Care Educational Program on the Severity of the Symptoms of Premenstrual Syndrome

• Register: IRCT
• Last refreshed on: 22 February 2018
• Main ID: IRCT2014060717998N1
• Date of registration: 2014-08-16
• Prospective Registration: No
• Primary sponsor: Shiraz University of Medical Sciences
• Public title: The Effect of Melissa Officinalis Capsules and Health Care Educational Program on the Severity of the Symptoms of Premenstrual Syndrome
• Scientific title: Comparison of the Effect of Melissa Officinalis Capsules and Health Care Educational Program on the Severity of the Symptoms of Premenstrual Syndrome in High School Girl Students in Shiraz
• Date of first enrolment: 2004-01-21
• Target sample size: 800
• Recruitment status: Complete
• URL: http://en.irct.ir/trial/16427
• Study type: interventional
• Study design: Randomization: N/A, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.
• Phase: N/A

Countries of recruitment

Iran (Islamic Republic of)

Contacts

• Name: Marzieh Akbarzadeh
• Affiliation: Shiraz University of Medical Sciences

• Name: Marzieh Akbarzadeh
• Affiliation: Shiraz University of Medical Sciences

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion criteria: willingness to participate in the study, obtaining informed consent from the parents of the students, not being in any stressful situation at the time of enrollment or during the study, presence in the educational sessions, not consuming vitamin supplements at the time of enrollment, not consuming hormonal medications such as contraceptives for at least 2 months before or during the study, a menstrual period of 3 to 7 days, lack of any underlying diseases such as thyroid diseases, diabetes mellitus and psychiatric disease. Exclusion criteria: the children’s willingness to leave the study, the request of the parents for exclusion of their children from the study, occurrence of a stressful event for the students or their parents during the study, absence of more than 2 sessions in group interactions and not compensating for missed sessions by participating in the sessions of other groups, consuming any medications during the study, any changes in the menstrual period (less than 3 days and more than 7 days), any changes in menstrual cycle length (less than 24 days and more than 35 days) and having stress during the study or in the last 3 months (such as death of the relatives, marriage or undergoing any surgical procedure).
Exclusion criteria:

Age minimum: 76 years
Age maximum: 72 years
Gender: Female

Health Condition(s) or Problem(s) studied

Premensstural Syndrom.
Premenstrual tension syndrome

Premenstrual tension syndrome

Intervention(s)

In the experimental group who receive Melissa officinalis capsules: The participants take a dosage of 1200 mg per day mg taken as 2 capsules of 600 mg from the first day of the menstrual cycle for 3 cycles. Researcher calls the research unit at least 3 to 4 times and talks to them call them for guidance. Capsules are given to the students monthly. The participants complete the questionnaires at the end of each month.

Treatment - Drugs

Placebo

Prevention

In the experimental group who attend health care educational program: The participants attend an educational program consisted of six two-hour educational sessions. The students complete the awareness and insight questionnaire once at the beginning of the program and once at the end of the 6th session.

In the control group of the educational program: The participants only complete the awareness and insight questionnaire.

Intervention 1: In the control group who receive placebo: The participants take a dosage of 1200 mg per day taken as 2 capsules of 600 mg from the first day of the menstrual cycle for 3 cycles. Researcher calls the research unit at least 3 to 4 times and talks to them call them for guidance. Capsules are given to the students monthly. The participants complete the questionnaires at the end of each month. Intervention 2: In the experimental group who attend health care educational program: The participants attend an educational program consisted of six two-hour educational sessions. The students complete the awareness and insight questionnaire once at the beginning of the program and once at the end of the 6th session. Intervention 3: In the control group of the educational program: The participants only complete the awareness and insight questionnaire. Intervention 4: In the experimental group who receive Melissa officinalis capsules: The participants take a dosage of 1200 mg per day mg taken as 2 capsules of 600 mg from the first day of the menstrual cycle for 3 cycles. Researcher calls the research unit at least 3 to 4 times and talks to them call them for guidance. Capsules are given to the students monthly. The participants complete the questionnaires at the end of each month.

In the control group who receive placebo: The participants take a dosage of 1200 mg per day taken as 2 capsules of 600 mg from the first day of the menstrual cycle for 3 cycles. Researcher calls the research unit at least 3 to 4 times and talks to them call them for guidance. Capsules are given to the students monthly. The participants complete the questionnaires at the end of each month.

Primary Outcome(s)

Physical symptoms of premenstrual syndrome. Timepoint: In the second step before the intervention and at the end of each month after the intervention (for 3 months. Method of measurement: Premenstrual Syndrome Screening Questionnaire.

Mental and emotional symptoms of premenstrual syndrome. Timepoint: In the second step before the intervention and at the end of each month after the intervention (for 3 months). Method of measurement: Premenstrual Syndrome Screening Questionnaire.

Secondary Outcome(s)

Individual's general health especially mental health. Timepoint: Before the intervention. Method of measurement: General Health Questionnaire (G.H.Q).

Source(s) of Monetary Support

Shiraz University of Medical Sciences

Ethics review

Status: Approved
Approval date:
Contact:

Ethics Committee of Shiraz University of Medical Sciences