Study of the effect of Curcumin in patients with Primary Dysmenorrhea
Design
Randomized,paralled group,not blinded clinical trial design include 80 patients,phase 3.
Settings and conduct
This study is a clinical trial on 80 patients with primary dysmenorrhea .The severity of dysmenorrhea measured by visual analog scale(VAS) and the need of non steroidal anti inflammatory drugs (NSAIDs) will be studied at begining of the study and two months after the intervention.Patients will be randomly divided into two groups of 40 patients(intervention group and control group).intervention group will receive two tablets of 500mg curcuma daily for two days before mensturation and three days after mensturation for two successive cycles.Data will be analyzed with SPSS version 23.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients with primary dysmenorrhea aged 18 to 30 years old, having
at least four recent consecutive painful menstrual cycles during
the past six months, bleeding of 3 to 7 days. Exclusion criteria:Taking contraceptives within the past two months, using intra-uterine device or drugs containing Curcumin within the past six
months, smoking and alcohol consuption, history of renal stones, granulomatous
disease, hyperparathyroidism, and any malignancy.
Intervention groups
intervention group will receive two tablets of 500mg curcuma daily for two days before mensturation and three days after mensturation for two successive cycles.control group will receive routine treatment which includes non steroidal anti inflammatory drugs (NSAIDs)
Main outcome variables
pain,the number of non steroidal anti inflammatory drugs (NSAIDs) used
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180404039187N8
Registration date:2020-10-07, 1399/07/16
Registration timing:registered_while_recruiting
Last update:2020-10-07, 1399/07/16
Update count:0
Registration date
2020-10-07, 1399/07/16
Registrant information
Name
Elnaz Shaseb
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 1337 2250
Email address
shasebe@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-11, 1399/05/21
Expected recruitment end date
2021-01-10, 1399/10/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of Curcumin in patients with Primary Dysmenorrhea
Public title
Evaluation effect of Curcumin in patients with Primary Dysmenorrhea
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Primary Dysmenorrhea
Aged 18 to 35 years old
Having at least four recent consecutive painful menstrual cycles during the past six months
Bleeding of 3 to 7 days during the menstruation
Exclusion criteria:
Taking contraceptives within the past two months
Using intra-uterine device or drugs containing Curcumin within the past six months
Smoking an alcohol consumption
Malignancy
Age
From 18 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Arrangement of the randomization process:
1) Determining the volume of each block (quadruple blocks)
2) Preparing the list of the blocks and assigning a number to each of them
AABB(1) ABAB(2) ABBA(3) BBAA(4) BABA(5) BAAB(6)
3) Choosing random numbers between 1 and 6
4) Defining the treatment assignment list
For example: AABB(1)_BBAA(4)_ABAB(2)_BABA(5)
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 Tabriz University of Medical Sciences
Street address
Research & Technology Dept, Central Building No. 2, Third Floor, Tabriz University of Medical Sciences, Golghast St, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2020-01-06, 1398/10/16
Ethics committee reference number
IR.TBZMED.REC.1398.1091
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 during menstruation
Timepoint
before intervention and 1, 2 months after intervention
Method of measurement
visual analogue scale
2
Description
needs of NSAIDs
Timepoint
before intervention and 1, 2 months after intervention
Method of measurement
DN4 Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:curcuma 500 mg twice daily from 2 days before menstruation until third day of mensuration for 2 months
Category
Treatment - Drugs
2
Description
Control group: routine treatment which includes non steroidal anti inflammatory drugs (NSAIDs)