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Comparison of the Effect of Matricaria Chamomilla Extract and Mefenamic Acid on intensity of premenstrual syndrome

Protocol summary

Summary
Premenstrual syndrome (PMS) is one of the commonest painful problems during reproductive age among women with associated symptoms occurring before menstruation, which affects their personal lives and causes them to miss work. Some clinical trials have revealed the effects of Matricaria Chamomilla (MC) on such pains. In the present randomized, double blind, parallel -group study, we compare the effects of MC Extract and Mefenamic Acid (MA) on the intensity of PMS. In doing so, 90 students of Kazerun Islamic Azad University living in the dormitory are enrolled in the study. Participants undergo a preliminary screening interview and screening for depression using Beck questionnaire. Then, the eligible ones complete daily form for the severity of PMS for two consecutive cycles. Those diagnosed with varying intensity, are randomly divided into two groups each receiving one 100 mg capsule of MC or MA 250 mg three times daily from 21st day of menstrual cycle till the beginning of the next. Inclusion criteria are as follows: Single students of 18-35 years of age, with regular menstruation and confirmed diagnosis of PMS but without any physical or psychological diseases, using no hormonal drugs, vitamins and herbal ones. Exclusion criteria include sensitivity to drugs, incorrect use of capsules, specific disease and taking medications during the study. The main Outcome measures including severity of psychological, physical and total symptoms of PMS are assessed before (two screening cycles) and after treatment (two treatment).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201201258801N2
Registration date: 2012-03-19, 1390/12/29
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-03-19, 1390/12/29
Registrant information
Name
Masoumeh Simbar
Name of organization / entity
Shahid Beheshti University for Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 2517
Email address
msimbar@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
The International Branch of Shahid Beheshti University of Medical Sciences and Health Services
Expected recruitment start date
2011-12-22, 1390/10/01
Expected recruitment end date
2012-06-19, 1391/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effect of Matricaria Chamomilla Extract and Mefenamic Acid on intensity of premenstrual syndrome
Public title
Comparison of the Effect of Matricaria Chamomilla Extract and Mefenamic Acid on intensity of premenstrual syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Single students; 18-35 years old; With normal body mass index (19.8 -26) ; No smoking; Regular menstrual cycles( 21-35 days) ; No physical disease (digestive problems like ulcers, diabetes, seizure disorders, hypothyroidism and endometriosis, and ...)and no known mental illnes; At least 5 symptoms of premenstrual syndrome symptoms in a temporary form of DSMIV with necessarily one symptoms from first to fourth (1 - Markedly depressed, mood and feelings of hopelessness, 2 - Significant anxiety, tension, feelings of impatience and anxiety, 3- Significant mood instability, such as sudden sadness, 4 - Continuous and apparent anger or irritability or increased interpersonal conflicts); lack of depression based on the Beck Depression questionnaire ; no history of consumption of Certain drugs (hormones, vitamins, antidepressants, herbal medicines, aspirin, warfarin); No allergy to herbal medicines; no sad event such as death of close relatives and surgery in the past six months; Not being professional athlete. Exclusion criteria: Sensitivity to drugs; Incorrect use of capsules (two capsules daily, if not, the person is excluded); Married during the study; Having specific disease and to take medications during the study; Occurrence of a sad event such as death of close relatives and surgery; To exercise professionally.
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The international Branch of Shahid Beheshti University of Medical Siences and Health Services
Street address
No 19, Shahid Abaspoor St, Next to Shahib Hemmat Bridge, Valiasr Ave
City
Tehran
Postal code
14155-3693
Approval date
2011-12-13, 1390/09/22
Ethics committee reference number
116/3742

Health conditions studied

1

Description of health condition studied
premenstural syndrom
ICD-10 code
N94.3
ICD-10 code description
Premenstrual tension syndrome

Primary outcomes

1

Description
The severity of physical symptoms of premenstrual syndrome
Timepoint
pre intervention, first month after intervention, second month after intervention
Method of measurement
Daily form of severity of premenstrual syndrome

2

Description
The severity of psychological symptoms of premenstrual syndrome
Timepoint
pre intervention, first month after intervention, second month after intervention
Method of measurement
Daily form of severity of premenstrual syndrome

3

Description
The severity of symptoms of premenstrual syndrome
Timepoint
pre intervention, first month after intervention, second month after intervention
Method of measurement
Daily form of severity of premenstrual syndrome

Secondary outcomes

1

Description
side effects of chamomile
Timepoint
first month after intervention, second month after intervention
Method of measurement
Questionnaire of effects and side effects of medication

2

Description
side effects of mefanamic acid capsule
Timepoint
first month after intervention, second month after intervention
Method of measurement
Questionnaire of effects and side effects of medication

Intervention groups

1

Description
chamomile extract, 100 mg capsule oral، 21st day till the beginning of next cycle one capsule three times daily
Category
Treatment - Drugs

2

Description
Mefenamic Acid capsules, 250 mg capsule oral , 21st day till the beginning of next cycle one capsule three times daily
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Fatemieh and Kosar Girls dormitories at Islamic Azad University, Kazerun Branch
Full name of responsible person
Girls dormitory residents
Street address
Islamic Azad University Kazerun Branch
City
Kazerun

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The international Branch of Shahid Beheshti University of Medical Siences and Health Services
Full name of responsible person
Dr. Ali Haeri
Street address
No 19, Shahid Abaspoor St, Next to Shahib Hemmat Bridge, Valiasr Ave
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The international Branch of Shahid Beheshti University of Medical Siences and Health Services
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
The international Branch of Shahid Beheshti University Of Medical Siences and Health Services
Full name of responsible person
Farangis Sharifi
Position
Master student of midwifery
Other areas of specialty/work
Street address
No 19, Shahid Abaspoor St, Next to Shahib Hemmat Bridge, Valiasr Ave
City
Tehran
Postal code
141553699
Phone
+98 218822090
Fax
Email
f_sharifi44@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Siences and Health Services
Full name of responsible person
Masoumeh Simbar
Position
PhD
Other areas of specialty/work
Street address
Faculity of Nursing and Midwifery, Valiasar street, Niayesh Ave.
City
Tehran
Postal code
Phone
+98 21 8820 2516
Fax
Email
msimbar@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
The international Branch of Shahid Beheshti University Of Medical Siences and Health Services
Full name of responsible person
Farangis Sharifi
Position
Master Student of Midwifery
Other areas of specialty/work
Street address
No 19, Shahid Abaspoor St, Next to Shahib Hemmat Bridge, Valiasr Ave
City
Tehran
Postal code
141553693
Phone
+98 21 8820 9020
Fax
Email
f_sharifi44@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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