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IRCT2016100825031N5 IRCT 2016-11-08 Arak University of Medical Sciences Effect of Ginger (Zingiber Officinale) and Chamomile Mixed Sachet with Honey in The Treatment of Primary Dysmenorrhea Comparison of the Efficacy of Ginger-Chamomile Mixed Sachet and Honey with Mefenamic Acid in The Treatment of Primary Dysmenorrhea and Associated Symptoms of Female Students that Living in the Arak University of Medical Sciences Dormitory: Randomized Controlled Clinical Trial 2016-10-22 anticipated 280 Complete https://irct.ir/trial/21012 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For Blindness and randomization will be used from numbered closed envelopes and block sampling, Blinding description: For Blindness will be used from numbered closed envelopes. Patients, researcher, physicians and statistical adviser do not know about the type of drug and groupings. N/A Primary dysmenorrhoea. Intervention 1: Group 1: sachet containing 1000 mg of ginger root powder and 5000 mg of chamomile with a teaspoonful of honey; 3 time a day, from 2 day before the beginning of menstrual cycle until 5 day. Intervention 2: Group 2: sachet that contain 1000 mg of ginger root powder with a teaspoonful of honey; 3 time a day, from 2 day before the beginning of menstrual cycle until 5 day. Intervention 3: Group 3: sachet that contain 5000 mg of chamomile with a teaspoonful of honey; 3 time a day, from 2 day before the beginning of menstrual cycle until 5 day. Intervention 4: Group 4: 250 mg mefenamic acid capsule manufactured by Raha pharmaceutical company; 3 time a day, from 2 day before the beginning of menstrual cycle until 5 day. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Fatemeh Shabani
Nursing Faculty, Arak University of Medical Sciences, Arak, Iran
Arak Iran (Islamic Republic of) 3819693345 +98 86 3417 3524 f.shabani@arakmu.ac.ir Arak University of Medical Sciences scientific Dr. Fatemeh Nejatbakhsh
Traditional Medicine Faculty, Tehran University of Medical Sciences, Tehran, Iran
Tehran Iran (Islamic Republic of) 1417733161 +98 21 8899 0837 nejatbakhsh@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Between 18 to 30 years old Unmarried The menstruation pain is started before 20 years old Regular menstrual cycles between 21 to 35 days Menstrual bleeding without passing clots Menstrual pain start a few hours before menstrual bleeding and to continue for 5 days Lack of chronic diseases Without peptic ulcer or duodenal ulcer Do not consume anticoagulant drugs Lack of burning, itching and abnormal vaginal discharge Without history of allergy to medicinal plants Lack of stress in the past two months Do not have to take medicine or special diet and smoking Without history of pelvic inflammatory disease Without history of gynecologic surgery Do not transfer or relocation during the next 6 months Do not have pain in all the time of menstrual bleeding Do not consume oral contraceptives Do not consume drugs class of benzodiazepines, barbiturates, narcotics and some antidepressants, such as fluoxetine Avoiding to use alcohol, aspirin, warfarin and heparin Without having specific diseases of liver, kidney and diagnosed depression 18 years 30 years Female Patient's refusal to participate in the study Consume drugs irregularly The incidence of significant stress factors during the study The incidence of any disease that requires to consume drugs, nutritional supplements or vitamins for long-term Doing any type of surgery during the study Marriage or change location Do not fill out the questionnaire Unwillingness to continue consume their medication by patients Avoiding the consume of medication as a single dose N94.4 Primary dysmenorrhoea Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Group 1: sachet containing 1000 mg of ginger root powder and 5000 mg of chamomile with a teaspoonful of honey; 3 time a day, from 2 day before the beginning of menstrual cycle until 5 day Group 2: sachet that contain 1000 mg of ginger root powder with a teaspoonful of honey; 3 time a day, from 2 day before the beginning of menstrual cycle until 5 day Group 3: sachet that contain 5000 mg of chamomile with a teaspoonful of honey; 3 time a day, from 2 day before the beginning of menstrual cycle until 5 day Group 4: 250 mg mefenamic acid capsule manufactured by Raha pharmaceutical company; 3 time a day, from 2 day before the beginning of menstrual cycle until 5 day The severity of bleeding. Timepoint: Before intervention and after the first and third menstrual cycle. Method of measurement: (PBACs) Pictorial Blood Loss Assessment Chart. Duration of bleeding. Timepoint: Before intervention and after the first and third menstrual cycle. Method of measurement: Measuring time. The severity of pain. Timepoint: Before intervention and after the first and third menstrual cycle. Method of measurement: Visual analog scale. Symptoms of dysmenorrhea. Timepoint: Before intervention and after the first and third menstrual cycle. Method of measurement: Verbal scale Anthresh - Mylsum. Arak University of Medical Sciences Approved 2016-07-25 Ethics Committe of Arak University of Medical Sciences Arak University of Medical Sciences, Basij Square, Sardasht, Arak, Iran Arak Markazi Iran (Islamic Republic of)