Protocol summary

Summary
This study investigated the effect of Melissa officinalis and Salvia officinalis on primary dysmenorrhea. This study was a clinical trial study and was performed on 120 single girls attending primary dysmenorrhea that Referred to Fatemieh hospital. That Experimental group used Melissa officinalis and Salvia officinalis five days before menstruation until five days during the menstruation and continue to next duration. 50 samples selected from Experimental group that were suitable and continued using medicinal plants till end of tow durations. Pain intensity, pain duration, blooding duration and gastrointestinal complications during the two cycles are measured with a questionnaire

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013012612278N1
Registration date: 2013-11-30, 1392/09/09
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-11-30, 1392/09/09
Registrant information
Name
Mosen Rajabi
Name of organization / entity
Applied Scientific University of Jihad-Agriculture
Country
Iran (Islamic Republic of)
Phone
+98 81 3437 3587
Email address
m.rajabi@areo.ir
Recruitment status
Recruitment complete
Funding source
Applied Sientific University of Jihad-Agriculture, Hamedan
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2013-07-23, 1392/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Salvia officinalis and Melissa officinalis on primary dysmenorrhea
Public title
The effect of Salvia officinalis and Melissa officinalis on primary dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Single girls; 13-30 years old; Have primary dysmenorrhea; Exclusion criteria: Those who were forced to use a particular drug; People who had a history of underlying disease (diabetes, etc) ; People with a history of pelvic inflammatory disease, fibroids, tumors, etc; People that faced stressors in the past six months; age was 31 and upper or lower than 13.
Age
From 13 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Hamedan University of Medical Science
Street address
Shahid Fahmideh Street, Hamedan University of Medical Science, Hamedan. Iran
City
Hamedan
Postal code
65178
Approval date
2013-05-05, 1392/02/15
Ethics committee reference number
332/9/35/16/پ/د

Health conditions studied

1

Description of health condition studied
Primary dysmenorrhoea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhoea

Primary outcomes

1

Description
Primary dysmenorrhoea
Timepoint
at the First study, third day, 6th day
Method of measurement
visual analogue scale

Secondary outcomes

1

Description
Blooding duration
Timepoint
30 days
Method of measurement
Questionnaire

Intervention groups

1

Description
Medicinal plants in packs of 25 gram, usage of the tail, 25 grams per day, 5 days befor dysmenorrhea untill 5 days after dysmenorrhea, twice a day for two months
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Hamedan Fatemieh Hospital
Full name of responsible person
Dr. Shoreh Alimohammadi
Street address
Pasdaran Street, Fatemieh Hospital, Hamedan, Iran
City
Hamedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Applied Scientific University of Jihad-Agriculture
Full name of responsible person
mohsen Rajabi
Street address
5 Km of Tehran Road, Opposite of Joraghan City, Applied Scientific University of Jihad-Agriculture
City
hamedan
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Applied Scientific University of Jihad-Agriculture
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
Applied Scientific University of Jihad-Agriculture
Full name of responsible person
Mohsen Rajabi
Position
University Teacher
Other areas of specialty/work
Street address
6 Km of Tehran Road, Opposite of Joraghan City, Applied Scientific University of Jihad-Agriculture, Hamedan, Iran
City
Hamedan
Postal code
6519631169
Phone
+98 81 1437 2802
Fax
+98 81 1437 2805
Email
m.rajabi@areo.irmhsnrajabi11278@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Agriculture and Natural Resources Research Center
Full name of responsible person
Ramezan Kalvandi
Position
Doctora Degree, Faculty Member
Other areas of specialty/work
Street address
5 Km of Tehran Road, Opposite of Organizational Departments of Gaz Company, Agriculture and Natural Resources Research Center
City
Hamedan
Postal code
Phone
+98 81 1437 3588
Fax
+98 81 1437 3592
Email
rkalvandi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Applied Scientific University of Jihad-Agriculture
Full name of responsible person
Mohsen Rajabi
Position
University Teacher
Other areas of specialty/work
Street address
5 Km of Tehran Road, Opposite of Joraghan City, Applied Scientific University of Jihad-Agriculture, Hamedan, Iran
City
Hamedan
Postal code
6519631169
Phone
+98 81 1437 2802
Fax
+98 81 1437 2805
Email
m.rajabi@areo.ir
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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