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The Effect of Turmeric on New Onset Primary Dysmenorrhea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04183556
Recruitment Status : Completed
First Posted : December 3, 2019
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Erhan Okuyan,M.D, Batman Maternity and Child's Health Hospital

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.

Condition or disease Intervention/treatment Phase
Primary Dysmenorrhea Drug: Naproxen Dietary Supplement: Turmeric Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Turmeric on New Onset Primary Dysmenorrhea
Actual Study Start Date : November 15, 2019
Actual Primary Completion Date : April 23, 2020
Actual Study Completion Date : April 23, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Period Pain

Arm Intervention/treatment
Active Comparator: 1/NSAI(nonsteroidal anti-inflammatory agent) group
Patients with naproxen drug therapy for early onset dysmenorrhea.
Drug: Naproxen
use of naproxen twice a day orally in mens time
Other Name: NSAI(nonsteroidal anti-inflammatory agent)

Placebo Comparator: 2/NSAI+ Turmeric (1 gram oral powder formula per day )
NSAI(nonsteroidal anti-inflammatory agent) + Turmeric for early onset dysmenorrhea (1 gram oral powder formula in mens time)
Drug: Naproxen
use of naproxen twice a day orally in mens time
Other Name: NSAI(nonsteroidal anti-inflammatory agent)

Dietary Supplement: Turmeric
Use of turmeric orally (1 gram powder formula) in mens time




Primary Outcome Measures :
  1. the effect of turmeric on visual analog scala at new onset primary dysmenorrhea [ Time Frame: 6 months ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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)
  2. Non-pregnant and breastfeeding patients
  3. Between 16-35 years old
  4. No anatomic pathology or disease
  5. Lack of active infection
  6. No history of drug use
  7. BMI is less than 25
  8. Those who wish to participate in the study signed the consent form
  9. Smoking, non-alcoholic patients
  10. Patients who completed their treatment and came to the control
  11. Regular menstruation

Exclusion Criteria:

  1. Presence of vaginal infection such as Trichomonas vaginalis and candida albicans
  2. Patients who do not want to participate in the study
  3. Pregnant and nursing patients
  4. Be under 16 years or older than 30 years
  5. Systemic disease
  6. Smoking, alcohol consumption
  7. BMI higher than 25
  8. People with organic pelvic pathology (ovarian cyst, fibroids, polyps)
  9. People with a history of drug use
  10. Patients who discontinue treatment and do not come to control
  11. Irregular menstruation
  12. Any history of contraindication to naproxen
  13. Turmeric allergy history

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04183556


Locations
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Turkey
Batman Maternity and Child's health Hospital
Batman, Turkey, 72000
Sponsors and Collaborators
Batman Maternity and Child's Health Hospital
Investigators
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Principal Investigator: erhan okuyan Batman Maternity and Child's Health Hospital
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Responsible Party: Erhan Okuyan,M.D, Obstetrician and gynaecologist, Batman Maternity and Child's Health Hospital
ClinicalTrials.gov Identifier: NCT04183556    
Other Study ID Numbers: BatmanMCHH
First Posted: December 3, 2019    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Erhan Okuyan,M.D, Batman Maternity and Child's Health Hospital:
new onset primary dysmenorrhea
turmeric
naproxen
Additional relevant MeSH terms:
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Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Neurologic Manifestations
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action