Comparison Efficacy of hydroalcholic extract of combined potions of 5 plants of Matricaria Chamomile, Cinnamon zeylanicum, Foeniculum vulgare, Cuminum cyminum and with Mefenamic acid in treatment of moderate to severe Dysmenorrhea in 15-45 year old women
Comparing effect of hydroalcholic extract of combined plants of Matricaria Matricaria chamomile, Cinnamon zeylanicum, Foeniculum vulgare, Cuminum cyminum and Zataria multiflora with Mefenamic acid in treatment of moderate and severe Dysmenorrhea
Design
In this non blinded randomized parallel clinical trial, 80 Patients are allocated randomly with simple sequential allocation in one of the two groups (herbal extract or mefenamic) and receive the intervention of that group.
Settings and conduct
Women aged 15-45 years old referring to Shahid Mofateh clinic of Yasuj suffering from severe dysmenorrhea allocated in one of two groups. the first group will received combined extract of 5 herbs provided in form of capsule ,then 2 day before onset of menstrual cycle till 3 days after one capsule prescribed with for two consecutive cycle. In second group mefenamic capsule 250 mg is prescribed every 8 hour same as first group. pain severity of patients(by Visual analogue scale (VAS) and changes in time and volume of menstrual bleeding will be checked and recorded by questionnaire during treatment and two weeks after that .
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women aged 15-45 years old with moderate to severe Dysmenorrhea, having informed consent form
Exclusion criteria: Patients with coagulation disorders, vaginal infection, pregnant women and those with a history of herbal or medicinal allergy.
Intervention groups
Combined extract of 5 herbs provided in form of capsule, then 2 day before menstrual cycle till 3 days after every 12 hours one capsule prescribed after meal with one glass of water for two sequential cycle.
In control group 250 mg mefenamic capsule is prescribed every 8 hour same as first group.
Main outcome variables
Severity of pain according to Visual analogue scales (VAS) and change in menstrual cycle by questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20081011001323N24
Registration date:2019-12-10, 1398/09/19
Registration timing:registered_while_recruiting
Last update:2019-12-10, 1398/09/19
Update count:0
Registration date
2019-12-10, 1398/09/19
Registrant information
Name
Sadrollah Mehrabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3334 6070
Email address
dr.mehrabi@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-01, 1398/08/10
Expected recruitment end date
2020-08-22, 1399/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison Efficacy of hydroalcholic extract of combined potions of 5 plants of Matricaria Chamomile, Cinnamon zeylanicum, Foeniculum vulgare, Cuminum cyminum and with Mefenamic acid in treatment of moderate to severe Dysmenorrhea in 15-45 year old women
Public title
effect of combined extract of Matricaria Chamomile, Cinnamon zeylanicum, Foeniculum vulgare, Cuminum cyminum and Zataria multiflora in treatment of Dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Childbearing women of 15-45 years old
Suffering from moderate to severe Dysmenorrhea
Having informed consent form to enter the study
Exclusion criteria:
Presence of vaginal infection
Presence of pelvic inflammation
Presence of benign or malignant pelvic tumor
Coagulopathy
Pregnancy
Allergy to medical or herbal drugs
Suffering from cardiopulmonary disease
Suffering from renal or hepatic disorder
Age
From 15 years old to 45 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are allocated randomly with simple random allocation method by use of random number table to one of each group combined herbal extract or mefenamic acid) and received the intervention of that group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yasuj University of Medical Sciences
Street address
Yasuj University of Medical Sciences, Mottahari srteet, Yasuj, Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741414
Approval date
2019-10-26, 1398/08/04
Ethics committee reference number
IR.YUMS.REC.1398.113
Health conditions studied
1
Description of health condition studied
Treatment of primary dysmenorrhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhea
Primary outcomes
1
Description
Pain intensity in dysmenorrhea
Timepoint
Before and during first 5 day of menstrual cycle in two consecutive cycle
Method of measurement
Visual Analogue Scale(VAS)
Secondary outcomes
1
Description
Changes in time and volume of menstrual bleeding
Timepoint
During treatment and two weeks after in two consecutive menstrual cycle
Method of measurement
By questionnaire and reports of patients
Intervention groups
1
Description
Intervention group: Combined extract of 5 herbs provided in form of capsule ,then 2 day before onset of menstrual cycle till 3 days after every 12 hours one capsule prescribed with one glass of water for two consecutive cycle.
Category
Treatment - Drugs
2
Description
Control group: Mefenamic capsule 250 mg is prescribed every 12 hour with one glass of water 2 day before onset of menstrual cycle till 3 days after it for two consecutive cycle.