A double blind, cross over, placebo controlled study of standardized hydro-alcoholic extract of stachys lavandulifolia on primary dysmenorrhea symptoms
Primary dysmenorrhea is one of the most frequent gynecological disorders in young women. As reported in literatures it has many economical and social impacts. According to past pharmacological studies it was confirmed that components of stachys may have some anxiolytic, anti-inflammatory, analgesic and spasmolytic effects. After preparation of standardized capsule formulation of hydro alcoholic extract of stachys lavandulifollia base on thymol, 30 women aged 18 to 45 years with diagnosis of primary dysmenorrhea were enrolled in this double blind randomized cross-over clinical trial. After control cycle and consumption of mefenamic acid in one cycle, each patient received either herbal capsules or placebo randomly. In next cycle placebo and herbal capsules were switched in a cross over manner. At the end of each cycle intensity of pain was evaluated by McGill pain questionnaire and visual analogue scale (VAS). Finally improvement rate and consumption of mefenamic acid capsules and probable side effects of drug were assessed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138904133106N2
Registration date:2010-12-19, 1389/09/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-12-19, 1389/09/28
Registrant information
Name
Farshad Hashemian
Name of organization / entity
Pharmaceutical Sciences Branch, Islamic Azad University (IAU)
Country
Iran (Islamic Republic of)
Phone
+98 21 2260 0037
Email address
hashemian.f@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
1- Pharmaceutical Sciences branch of Islamic Azad University, 2- investigators financial sources
Expected recruitment start date
2010-02-01, 1388/11/12
Expected recruitment end date
2013-06-01, 1392/03/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A double blind, cross over, placebo controlled study of standardized hydro-alcoholic extract of stachys lavandulifolia on primary dysmenorrhea symptoms
Public title
The effect of stachys lavandulifolia extract on the symptoms of primary dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria : 1-age of 18-45 years, 2- diagnosis of primary dysmenorrheal, 3- existence of dysmenorrhrea in most of cycles. Exclusion criteria: 1-pregnancy, 2- lactation, 3-abnormal vaginal bleeding, 4-moderate to sever menorrhagia, 5-BMI more than 30, 6-OCP and other hormonal drugs consumption.
Age
From 18 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Pharmaceutical science branch of Islamic azad university
Street address
No.99, Yakhchal street, Dr. Shariati Avenue
City
Tehran
Postal code
Approval date
2010-07-05, 1389/04/14
Ethics committee reference number
4113
Health conditions studied
1
Description of health condition studied
Primary dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhea
Primary outcomes
1
Description
severity of pain
Timepoint
at the end each cycle up to three cycles
Method of measurement
macgill pain questionnaire
2
Description
severity of pain
Timepoint
at the end each cycle up to three cycles
Method of measurement
visual analogue scale (VAS)
Secondary outcomes
1
Description
side effects
Timepoint
at the end each cycle up to three cycles
Method of measurement
questionnaire
Intervention groups
1
Description
Placebo: In case of existence of dysmenorrheal pain, 24 hours before initiation of approximate cycle time till 48 hours after, patients should take 1 capsule and repeat it each 4-6 hours if needed.
Category
Placebo
2
Description
Herbal capsule: In case of existence of dysmenorrheal pain, 24 hours before initiation of approximate cycle time till 48 hours after, patients should take 1 capsule and repeat it each 4-6 hours if needed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Buali hospital
Full name of responsible person
Fatemeh Mohammadyari
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Pharmaceutical science branch of Islamic Azad university
Full name of responsible person
Dr. Orkideh Ghorban dadras
Street address
No.99, Yakhchal street, Dr. Shariati Avenue
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Pharmaceutical science branch of Islamic Azad university
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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Pharmaceutical science branch of Islamic azad university
Full name of responsible person
Dr. Farshad Hashemian
Position
Assistant professor / Head of Department
Other areas of specialty/work
Street address
No.99, Yakhchal street, Dr. Shariati Avenue
City
Tehran
Postal code
Phone
+98 21 2264 0051
Fax
+98 21 8857 7961
Email
hashemian.f@iaups.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)