Studying and comparing the effectiveness of nano-curcumin to curcumin in the pain of primary dysmenorrhea
Design
A placebo controlled, parallel group, double blind, in three randomised controlled groups, phase 3 clinical trial
Settings and conduct
In this double blind experiment, qualified models will be chosen by questionnaire at the universities and Shohadaye Tajrish Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
having primary dysmenorrhea
age of 18-27
Informed consent
Exclusion criteria:
pregnancy and lactation
hypersensitivity to the Curcumin products
using other drugs
asthma, GI tract diseases, cholelithiasis and obstruction of gull duct
intolerance of NSAIDs
using anti-coagulant agents
developing ovarian cysts
using OCPs
Intervention groups
Patients enter in 3 groups which two of them will be treatment group and the other group will be a control group. All three groups will receive mefenamic acid for the control of menstural pain. Control group will receive mefenamic acid and placebo for three consecutive menstural periods. Nano-curcumin group will receive mefenamic acid and nano-curcumin for three consecutive menstural periods. Curcumin group will receive mefenamic acid and curcumin for three consecutive menstural periods.
Main outcome variables
Pain severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160813029327N11
Registration date:2018-05-27, 1397/03/06
Registration timing:registered_while_recruiting
Last update:2018-05-27, 1397/03/06
Update count:0
Registration date
2018-05-27, 1397/03/06
Registrant information
Name
Ramin Abrishami
Name of organization / entity
Islamic Azad University, Pharamceutical sciences branch
Country
Iran (Islamic Republic of)
Phone
+98 21 2264 1889
Email address
r_abrishami@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-15, 1397/01/26
Expected recruitment end date
2018-09-17, 1397/06/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of nano-Curcumin with Curcumin and control group on primary dysmenorrhea among 18-27 years old women
Public title
ُStuding the effect of Nano-curcumin and curcumoup in primary dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
having primary dysmenorrhea
age of 18-27
Informed consent
Exclusion criteria:
pregnancy and lactation
hypersensitivity to the Curcumin products
using other drugs
asthma, GI tract diseases, cholelithiasis and obstruction of gull duct
intolerance of NSAIDs
using anti-coagulant agents
developing ovarian cysts
using OCPs
Age
From 18 years old to 27 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Random number table: based on Random Sequence Generator via random.org website three groups were made. Patients were allocated in one of three groups based on their entry sequence.
Blinding (investigator's opinion)
Double blinded
Blinding description
This is a double blind study in which both researcher and patients don't know that which drug the patient have been used. Drugs will be dispensed by a third person in uniform packages with codes. Instructions on the number of consumption will not be seen by the prescriber.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee ofَ Islamic Azad University of Tehran Medical Science
Street address
Shariati Ave, Yakhchal Street, Tehran.
City
Tehran
Province
Tehran
Postal code
1941933111
Approval date
2017-08-27, 1396/06/05
Ethics committee reference number
IR.IAU.PS.REC.1396.143
Health conditions studied
1
Description of health condition studied
Dysenorrhea
ICD-10 code
N94.4
ICD-10 code description
Primary dysmenorrhoea
Primary outcomes
1
Description
Intensity of pain in primary dysmenorrhea
Timepoint
The measurement of intensity of pain, in first 3 days of 4 consecutive menstural period
Method of measurement
Visual Analogue Scale and quality of life questionnaire
Secondary outcomes
1
Description
Quantity of Mefenamic acid
Timepoint
Patients in first month will just use Mefenamic acid and in three following months will use mefenamic acid besides study drugs if it is necessary.
Method of measurement
By questionnaire.
Intervention groups
1
Description
Intervention group 1: first intervention group is nano-curcumin group. This medicine in the form of 80 mg soft gelatin capsule will be consumed once daily by oral route for the first three days of menstruation for 3 consecutive months. Nano-Exir Sina is the manufacturer of this drug.
Category
Treatment - Drugs
2
Description
Control group: patients in this group will receive one 80 mg of placebo capsule daily by oral route for the first three days of menstruation for 3 consecutive months.
Category
Placebo
3
Description
Intervention group: Group 2 receives curcumin 500 mg tablets, tablets are manufactured by Dineh, Tehran, Iran. Tablets will be consumed twice daily by oral route for the first three days of menstruation for 3 consecutive months.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Tajrish Hospial, Islamic Azad university of Medical Sience
Full name of responsible person
Ramin Abrishami
Street address
Shariati Ave, Yakhchal Street, Tehran.
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0051
Fax
+98 21 2260 2059
Email
r_abrishami@iaups.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Yalda Ahmadnia
Street address
Shariati Ave, Yakhchal Street, Tehran.
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0051
Email
Yaldaa.am.nia@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
1
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ramin Abrishami
Position
associated professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Shariati Ave, Yakhchal Street, Tehran.
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 1889
Fax
+98 21 2264 1889
Email
r_abrishami@iaups.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ramin Abrishami
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Shariati Ave, Yakhchal Street, Tehran.
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 1889
Fax
+98 21 2264 1889
Email
r_abrishami@iaups.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ramin Abrishami
Position
Ramin Abrishami
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Shariati Ave, Yakhchal Street, Tehran.
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 1889
Fax
+98 21 2264 1889
Email
r_abrishami@iaups.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Unidentified demographic and variables will be shared.
When the data will become available and for how long
After publication upto three years
To whom data/document is available
Academics
Under which criteria data/document could be used
Academic and/or clinical use
From where data/document is obtainable
via email to corresponding author
What processes are involved for a request to access data/document