Effect of aerobic exercise and consumption of curcumin on Premenstrual syndrome

• Register: IRCT
• Last refreshed on: 22 February 2018
• Main ID: IRCT2017010331745N1
• Date of registration: 2017-04-22
• Prospective Registration: No
• Primary sponsor: Vice Chancellor for research of Islamic Azad University Central Tehran Branch
• Public title: Effect of aerobic exercise and consumption of curcumin on Premenstrual syndrome
• Scientific title: Effect of aerobic exercise and consumption of curcumin on physiological parameters and edema in 18-35 years old women with premenstrual syndrome
• Date of first enrolment: 2016-06-04
• Target sample size: 44
• Recruitment status: Complete
• URL: http://en.irct.ir/trial/24908
• Study type: interventional
• Study design: Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.
• Phase: N/A

Countries of recruitment

Iran (Islamic Republic of)

Contacts

• Name: Ladan Zoodfekr
• Affiliation: Islamic Azad univrsiy

• Name: Ladan Zoodfekr
• Affiliation: Islamic Azad University

Key inclusion & exclusion criteria

Inclusion criteria: Inclusion criteria: 18-35 year old; Having regular menstrual cycles ( 28-35 days); Suffering from moderate or severe PMS and at least have five physical symptoms based on Dickerson questionnaire; Do not Consumption effective drugs (chemical or herbal) on the premenstrual syndrome in the recent quarter. Exclusion criteria: physical and mental illnesses like diabetes, biliary or kidney disease, epilepsy, thyroid disease or other metabolic disorders; Consumption hormonal, anti convulsants and anti depression drugs; Smoking and drug abuse.
Exclusion criteria:

Age minimum: 18 years
Age maximum: 35 years
Gender: Female

Health Condition(s) or Problem(s) studied

premenstrual syndrome.
Premenstrual tension syndrome

Premenstrual tension syndrome

Intervention(s)

Corn starch
100 mg oral capsules
twice a day(from a week before mense till 3 days after bleeding)
for 3 months

curcumin
100 mg oral capsules
twice a day(from a week before mense till 3 days after bleeding)
for 3 months

curcumin 100 mg oral capsules, twice a day (from a week before mense till 3 days after bleeding)for 3 months + aerobic exercise with 50-60 % maximum heart rate, 3 times a week, 1 hour each day, for 3 months

Placebo

Do aerobic exercise with 50-60 % maximum heart rate, 3 times a week, 1 hour daily, for 3 months

Lifestyle

Intervention 1: curcumin 100 mg oral capsules, twice a day (from a week before mense till 3 days after bleeding)for 3 months + aerobic exercise with 50-60 % maximum heart rate, 3 times a week, 1 hour each day, for 3 months. Intervention 2: curcumin
100 mg oral capsules
twice a day(from a week before mense till 3 days after bleeding)
for 3 months. Intervention 3: Corn starch
100 mg oral capsules
twice a day(from a week before mense till 3 days after bleeding)
for 3 months. Intervention 4: Do aerobic exercise with 50-60 % maximum heart rate, 3 times a week, 1 hour daily, for 3 months.

Treatment - Drugs

Primary Outcome(s)

Physical Indicators of Premenstrual syndrome. Timepoint: before intervention and 3 months after intervention. Method of measurement: Dickerson standard questionnaire , blood Measurements.

Progesteron. Timepoint: before intervention and 3 months after intervention. Method of measurement: Dickerson standard questionnaire , blood Measurements.

Prolactin. Timepoint: before intervention and 3 months after intervention. Method of measurement: Dickerson standard questionnaire , blood Measurements.

Edema. Timepoint: before intervention and 3 months after intervention. Method of measurement: Dickerson standard questionnaire , blood Measurements.

Blood suger. Timepoint: before intervention and 3 months after intervention. Method of measurement: Dickerson standard questionnaire , blood Measurements.

Prostaglandin E2. Timepoint: before intervention and 3 months after intervention. Method of measurement: Dickerson standard questionnaire , blood Measurements.

Psychological Indicators of Premenstrual syndrome. Timepoint: before intervention and 3 months after intervention. Method of measurement: Dickerson standard questionnaire , blood Measurements.

Estrogen. Timepoint: before intervention and 3 months after intervention. Method of measurement: Dickerson standard questionnaire , blood Measurements.

Emotional Indicators of Premenstrual syndrome. Timepoint: before intervention and 3 months after intervention. Method of measurement: Dickerson standard questionnaire , blood Measurements.

Secondary Outcome(s)

Prolactin. Timepoint: before intervention and 3 months after intervention. Method of measurement: Dickerson standard questionnaire , blood Measurements.

Blood suger. Timepoint: before intervention and 3 months after intervention. Method of measurement: Dickerson standard questionnaire , blood Measurements.

Prostaglandin E2. Timepoint: before intervention and 3 months after intervention. Method of measurement: Dickerson standard questionnaire , blood Measurements.

Psychological Indicators of Premenstrual syndrome. Timepoint: before intervention and 3 months after intervention. Method of measurement: Dickerson standard questionnaire , blood Measurements.

Esterogen. Timepoint: before intervention and 3 months after intervention. Method of measurement: Dickerson standard questionnaire , blood Measurements.

Progesteron. Timepoint: before intervention and 3 months after intervention. Method of measurement: Dickerson standard questionnaire , blood Measurements.

Emotional Indicators of Premenstrual syndrome. Timepoint: before intervention and 3 months after intervention. Method of measurement: Dickerson standard questionnaire , blood Measurements.

Edema. Timepoint: before intervention and 3 months after intervention. Method of measurement: Dickerson standard questionnaire , blood Measurements.

Physical Indicators of Premenstrual syndrome. Timepoint: before intervention and 3 months after intervention. Method of measurement: Dickerson standard questionnaire , blood Measurements.

Source(s) of Monetary Support

Vice Chancellor for research of Islamic Azad University Central Tehran Branch

Ethics review

Status: Approved
Approval date:
Contact:

Ethics Committee of Sport Sciences Research Institute of Iran