The aim of this study is to assess the severity of the symptoms of the premenstrual syndrome and compare the therapeutic effects of ginger and curcumin on the symptoms of premenstrual syndrome. This study is clinical trial ,double-blind, randomized, and parallel group in comparison with placebo .It will study on 105 students of the dormitory of Tehran University of Medical Sciences . Inclusion criteria included having regular menstrual cycles 21-35 days, Physical and mental health , non sensitive to turmeric and ginger . Exclusion criteria included Unwillingness to continue participation in the study , Identification of any disease such as endocrine disease , If they have complications or allergic response to a drug or do not take the drugs. At first step, they will fill a questionnaire about their symptoms for two menstrual cycles . After identifying students with premenstrual syndrome, the students of this study will divide randomly to three groups include of ginger (500 mg) group, curcumin group (200 mg) and placebo control group. Each student will take two capsules daily during three cycles from seven days before menstruation to three days after it and records the severity of the symptoms of her menstruation in the questionnaire of the symptoms. The result of this Study for the students is determination variation of the severity of mental, physical and behavior symptoms of premenstrual syndrome.
General information
Acronym
PMS
IRCT registration information
IRCT registration number:IRCT201301012751N7
Registration date:2013-06-10, 1392/03/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-06-10, 1392/03/20
Registrant information
Name
Masoomeh Kheirkhah
Name of organization / entity
Iran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8247 1000
Email address
kheirkhah@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-05-09, 1392/02/19
Expected recruitment end date
2013-11-22, 1392/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of ginger and curcumin on severty of premenstural syndrome symptoms
Public title
The impact of ginger and curcumin on severty of premenstural syndrome symptoms
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Regular menstrual cycles 21-35 days, 18-35 years of age , unmarried, Physical and mental health , non-hormonal drugs, anticoagulant, antidepressants, supplements and herbal medicine, Not sensitive to turmeric and ginger , not taking any medication for the treatment of premenstrual syndrome, No alcohol or drugs, Non-traumatic stress in the last 3 months, no surgery in the last 3 months.
Exclusion criteria: Unwillingness to continue participation in the study , If complications or allergic to a drug or other drug use, If stop taking the medication or taking medication irregularly , Identification of any disease such as endocrine disease, married during the study , Menstrual cycle irregularity during the study , Stressful events occurred during the study
Age
From 18 years old to 35 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
105
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
2. Nursing and Midwifery Faculty, Tehran University of Medical Sciences
Street address
Tehran, Nosrat street, Tohid squar
City
Tehran
Postal code
1417933331
Approval date
2013-04-27, 1392/02/07
Ethics committee reference number
92/د/130/97
Health conditions studied
1
Description of health condition studied
premenstrual syndrome
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome
Primary outcomes
1
Description
Reduction in physical symptoms (headache, breast swelling and tenderness, back pain, abdominal pain, muscle pain, weight gain, swelling of extremities, nausea, diarrhea or constipation)
Timepoint
One month, two months, three months after intervention
Method of measurement
Questionnaire
2
Description
Reduction in mood symptoms (irritability and restlessness, anxiety and impatience, anger, depression and sadness, crying for no reason, feeling alone)
Timepoint
One month, two months, three months after intervention
Method of measurement
Questionnaire
3
Description
Reduction in behavioral symptoms (fatigue, lack of energy, insomnia, difficulty concentrating, increased appetite)
Timepoint
One month, two months, three months after intervention
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Side effects of drugs
Timepoint
Three months after the intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
ginger Capsules, 250 mg, 2 times a day, orally for 3 months
Category
Treatment - Drugs
2
Description
Placebo capsules, 100 mg, 2 times a day, orally for 3 months
Category
Treatment - Drugs
3
Description
curcumin Capsules, 100 mg, 2 times a day, orally for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dormitory of Tehran University of Medical Sciences
Full name of responsible person
samira khayat
Street address
Nursing and Midwifery Faculty of Tehran University of Medical Sciences
City
tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Nursing and Midwifery Faculty of Tehran University of Medical Sciences
Full name of responsible person
masoomeh kheirkhah
Street address
Nursing and Midwifery Faculty of Tehran University of Medical Sciences
City
tehran
Grant name
دانشکده پرستاری و مامایی دانشگاه علوم پزشکی تهران
Grant code / Reference number
Nursing and Midwifery Faculty of Tehran University of Medical Sciences
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nursing and Midwifery Faculty of Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Nursing and Midwifery Faculty of Tehran University of Medical Sciences
Full name of responsible person
Masoomeh Kheirkhah
Position
University Lecturer, Master of Midwifery
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty of Tehran University of Medical Sciences
City
tehran
Postal code
1419733171
Phone
+98 21 6105 4312
Fax
+98 912 413 7578
Email
m-kheirkhah@tums.ac.ir
Web page address
http://fnm.tums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nursing and Midwifery Faculty of Tehran University of Medical Sciences
Full name of responsible person
Masoomeh Kheirkhah
Position
University Lecturer, Master of Midwifery
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty of Tehran University of Medical Sciences
City
tehran
Postal code
1419733171
Phone
+98 21 6105 4312
Fax
+98 912 413 7578
Email
m-kheirkhah@tums.ac.ir
Web page address
http://fnm.tums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Nursing and Midwifery Faculty of Tehran University of Medical Sciences
Full name of responsible person
Masoomeh Kheirkhah
Position
University Lecturer, Master of Midwifery
Other areas of specialty/work
Street address
Nursing and Midwifery Faculty of Tehran University of Medical Sciences
City
tehran
Postal code
1419733171
Phone
+98 21 6105 4312
Fax
Email
m-kheirkhah@tums.ac.ir
Web page address
http://fnm.tums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)