Back to resultsThe Effect of Turmeric on New Onset Primary Dysmenorrhea
Primary Purpose
Primary Dysmenorrhea
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Naproxen
Turmeric
Sponsored by
About this trial
This is an interventional treatment trial for Primary Dysmenorrhea focused on measuring new onset primary dysmenorrhea, turmeric, naproxen
Eligibility Criteria
Inclusion Criteria:
- Early-onset primary dysmenorrhea (Definition: Pain that begins in less than 6 months, is not accompanied by infection, begins on the first day of menstruation and ends on the last day of menstruation)
- Non-pregnant and breastfeeding patients
- Between 16-35 years old
- No anatomic pathology or disease
- Lack of active infection
- No history of drug use
- BMI is less than 25
- Those who wish to participate in the study signed the consent form
- Smoking, non-alcoholic patients
- Patients who completed their treatment and came to the control
- Regular menstruation
Exclusion Criteria:
- Presence of vaginal infection such as Trichomonas vaginalis and candida albicans
- Patients who do not want to participate in the study
- Pregnant and nursing patients
- Be under 16 years or older than 30 years
- Systemic disease
- Smoking, alcohol consumption
- BMI higher than 25
- People with organic pelvic pathology (ovarian cyst, fibroids, polyps)
- People with a history of drug use
- Patients who discontinue treatment and do not come to control
- Irregular menstruation
- Any history of contraindication to naproxen
- Turmeric allergy history
Sites / Locations
- Batman Maternity and Child's health Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1/NSAI(nonsteroidal anti-inflammatory agent) group
2/NSAI+ Turmeric (1 gram oral powder formula per day )
Arm Description
Patients with naproxen drug therapy for early onset dysmenorrhea.
NSAI(nonsteroidal anti-inflammatory agent) + Turmeric for early onset dysmenorrhea (1 gram oral powder formula in mens time)
Outcomes
Primary Outcome Measures
the effect of turmeric on visual analog scala at new onset primary dysmenorrhea
To determine the effect of turmeric use on pain severity in early onset primary .The minimum pain score for dysmenorrhea is defined as 1 maximal pain score of 10 and a significant difference is planned if there is a significant difference between pretreatment scores and post-treatment scores if at least 50 percent reduction in turmeric use is achieved.It is predicted that there is no significant difference in visual analog scale scoring less than 50 percent and treatment is not effective.
Before and after the treatment of turmeric effect on visual analog scores will be compared and a significant difference will be observed if at least 50 percent improvement is detected.dysmenorrhea using visual analogue scoring.
The percentage of reduction in visual analog scores will be calculated in all patients using turmeric.
Secondary Outcome Measures
Full Information
NCT ID
NCT04183556
First Posted
November 24, 2019
Last Updated
April 22, 2020
Sponsor
Batman Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04183556
Brief Title
The Effect of Turmeric on New Onset Primary Dysmenorrhea
Official Title
The Effect of Turmeric on New Onset Primary Dysmenorrhea
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
November 15, 2019 (Actual)
Primary Completion Date
April 23, 2020 (Actual)
Study Completion Date
April 23, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Batman Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study was planned as 150 patients. Patients who met early-onset dysmenorrhea criteria and who met the inclusion criteria; 150 patients were divided into 2 equal groups, and NSAID during the menstrual cycle, nsai + turmeric 1 gr oral powder form treatment was planned to be started in the other group. The pain frequency and severity before and after treatment were evaluated by visual analog scale and the two groups were compared.
Detailed Description
There are scientific publications on the use of turmeric, which constitutes the hypothesis of our study, in branches such as cardiology, neurology, infertility and chest diseases due to its anti-inflammatory, anti-aging properties.
The data are planned to be evaluated by the researchers using the SPSS(Statistical Package for the Social Sciences ) 17.0 program on computer. The responses of all groups to the VAS scores are planned to be entered into the system by using the SPSS program before and after treatment. statistics (number, percentage, mean, standard deviation), chi-square and logistic regression analysis are used to compare categorical variables. Chi-square test and Mann Whitney-U test are planned to be used in comparison between groups.When examining the difference between the groups, if the p value is less than 0.05, it is planned as a proof of significant difference.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea
Keywords
new onset primary dysmenorrhea, turmeric, naproxen
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1/NSAI(nonsteroidal anti-inflammatory agent) group
Arm Type
Active Comparator
Arm Description
Patients with naproxen drug therapy for early onset dysmenorrhea.
Arm Title
2/NSAI+ Turmeric (1 gram oral powder formula per day )
Arm Type
Placebo Comparator
Arm Description
NSAI(nonsteroidal anti-inflammatory agent) + Turmeric for early onset dysmenorrhea (1 gram oral powder formula in mens time)
Intervention Type
Drug
Intervention Name(s)
Naproxen
Other Intervention Name(s)
NSAI(nonsteroidal anti-inflammatory agent)
Intervention Description
use of naproxen twice a day orally in mens time
Intervention Type
Dietary Supplement
Intervention Name(s)
Turmeric
Intervention Description
Use of turmeric orally (1 gram powder formula) in mens time
Primary Outcome Measure Information:
Title
the effect of turmeric on visual analog scala at new onset primary dysmenorrhea
Description
To determine the effect of turmeric use on pain severity in early onset primary .The minimum pain score for dysmenorrhea is defined as 1 maximal pain score of 10 and a significant difference is planned if there is a significant difference between pretreatment scores and post-treatment scores if at least 50 percent reduction in turmeric use is achieved.It is predicted that there is no significant difference in visual analog scale scoring less than 50 percent and treatment is not effective.
Before and after the treatment of turmeric effect on visual analog scores will be compared and a significant difference will be observed if at least 50 percent improvement is detected.dysmenorrhea using visual analogue scoring.
The percentage of reduction in visual analog scores will be calculated in all patients using turmeric.
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Early-onset primary dysmenorrhea (Definition: Pain that begins in less than 6 months, is not accompanied by infection, begins on the first day of menstruation and ends on the last day of menstruation)
Non-pregnant and breastfeeding patients
Between 16-35 years old
No anatomic pathology or disease
Lack of active infection
No history of drug use
BMI is less than 25
Those who wish to participate in the study signed the consent form
Smoking, non-alcoholic patients
Patients who completed their treatment and came to the control
Regular menstruation
Exclusion Criteria:
Presence of vaginal infection such as Trichomonas vaginalis and candida albicans
Patients who do not want to participate in the study
Pregnant and nursing patients
Be under 16 years or older than 30 years
Systemic disease
Smoking, alcohol consumption
BMI higher than 25
People with organic pelvic pathology (ovarian cyst, fibroids, polyps)
People with a history of drug use
Patients who discontinue treatment and do not come to control
Irregular menstruation
Any history of contraindication to naproxen
Turmeric allergy history
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
erhan okuyan
Organizational Affiliation
Batman Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Batman Maternity and Child's health Hospital
City
Batman
ZIP/Postal Code
72000
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Turmeric on New Onset Primary Dysmenorrhea
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