Objective: determine the effect of cumminum cyminum capsule on dysmenorrhea and menstrual bleeding in IUD users. This is a triple-blind, multi-central, randomized clinical trial and cross over study. Method: inclusion criteria: contraceptive method is cupper T380 IUD; 6 months up to 3 years passed after the IUD insertion; with moderate or severe dysmenorrhea assessed by verbal multi-dimensional scoring system; absence of known gastrointestinal, hepatic, thyroid, nephrogenic and cardiovascular disease; absence of NSAIDS and cumin sensitivities.
Exclusion criteria: using the capsules not according to medical prescription; taking any kind of medical or herbal analgesic or hormonal drugs during intervention ans removal of IUD. 100 IUD users participate in this study after being informed and signing the written consent. In the first month, pain intensity and menstrual bleeding will be assessed by VAS and Higham chart, then they are randomly allocated in two groups. Each group take their medication 3 times a day for 7 days from the start of their menstrual period. In the control group, women receive two capsules containing 250 mg mefenamic acid. The intervention group women receive two capsules containing 500 mg cumin powder. They receive this drugs for two menstrual period. The capsules in all groups are similar in shape and package. Then each research unit receive the same treatment of the opposite group with the same characteristics. Duration of this stage is two menstrual period. Total sample size will be 200 and VAS and Higham chart will be completed during this five months research period.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201208106284N4
Registration date:2012-08-15, 1391/05/25
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-08-15, 1391/05/25
Registrant information
Name
Maryam Modarres
Name of organization / entity
Tehran university of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6656 8142
Email address
modarres@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences,vice chancellor for research
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2012-10-22, 1391/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation effect of cumminum cyminum capsule on dysmenorrhea and menstrual bleeding in IUD users.
Public title
Effect of cumminum cyminum capsule on dysmenorrhea and menstrual bleeding in IUD users.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: contraceptive method is cupper T380 IUD; 6 months up to 3 years passed after the IUD insertion; with moderate or severe dysmenorrhea assessed by verbal multi-dimensional scoring system; absence of known gastrointestinal, hepatic, thyroid, nephrogenic and cardiovascular disease; absence of NSAIDS and cumin sensitivities.
Exclusion criteria: using the capsules not according to medical prescription; taking any kind of medical or herbal analgesic or hormonal drugs during intervention ans removal of IUD.
Age
From 15 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
floor6,central organization of university , qods street,keshavarz blv
City
Tehran
Postal code
Approval date
2012-07-01, 1391/04/11
Ethics committee reference number
د/130/579/91
Health conditions studied
1
Description of health condition studied
Secondary dysmenorrhoea in IUD users
ICD-10 code
N94.5
ICD-10 code description
Secondary dysmenorrhoea
2
Description of health condition studied
Menstrual bleeding in IUD users
ICD-10 code
N92
ICD-10 code description
Excessive and frequent menstruation with regular cycle,Excessive and frequent menstruation with irregular cycle
Primary outcomes
1
Description
Severity of dysmenorrhea
Timepoint
At the start of menstrual bleeding,24 hours,48hours,72hours and 7 days after starting menstrual bleeding ,before and after interven tion
Method of measurement
Visual analgue scale (VAS)
2
Description
Menstrual bleeding
Timepoint
During the menstrual bleeding, before and after intervention
Method of measurement
Pictorial blood loss assessment chart(higham chart)
Secondary outcomes
1
Description
Severity of physical symptom of dysmenorrhea
Timepoint
At the end of first month,third month and fifth month of research
Method of measurement
Check list of physical symptom of dysmenorrhea
Intervention groups
1
Description
Cumminum cyminum powder, 500 mg capsule oral, 7days from starting menstrual bleeding , two capsule three times daily
Category
Treatment - Drugs
2
Description
Mefenamic Acid capsules,250 mg capsule,7 days from starting menstrual bleeding,two capsules three times daily,similar in shape and package as same as intervention group