]>
IRCT20240506061675N1 IRCT 2024-05-26 Shahid Beheshti University of Medical Sciences Investigating the effect of Oral capsule of Ziziphora tenuior plant extract on Primary Dysmenorrhoea Investigating the effect of Oral capsule of Ziziphora tenuior plant extract on Primary Dysmenorrhoea 2024-06-08 anticipated 94 Complete https://irct.ir/trial/76707 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Quota sampling will be done based on the number of students from the dormitories (Al-Zahra, Hazrat Zainab, Somayeh, Gol Narges and Sarshar). The sampling method is available, but the allocation of random samples will be simple using the random numbers function of Excel software. The samples will be divided into two groups of case and control by simple random and using the function of random numbers of Excel software, Blinding description: This is a Triple blind clinical trial study in which both the participants, the researcher and the Data Safety and Monitoring Committee, are not aware of the type of drug used. For the purpose of blinding, the pharmacist will put the drugs in two separate categories with completely identical appearance and coded A and B without the knowledge of the researcher. Then each of the samples will be given an envelope with a specific code and in similar packaging. 3 Primary dysmenorrhea. Intervention 1: Intervention group: In this study, the intervention group consumes the oral capsule of Ziziphora tenuior plant extract. In this research, the Ziziphora tenuior plant was collected from the authentic perfumers of Bojnoord city, North Khorasan province, and it was confirmed by the respected botanist of the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences. Half a gram of extract is obtained from every 10 grams of dried leaves of this plant, and each capsule contains 350 milligram of Ziziphora tenuior extract. The capsule will be prepared in collaboration with the pharmacology specialist of the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences, which is prescribed in two cycles and in three divided doses every 8 hours during the menstrual cycle. Intervention 2: Control group: In this study, the control group consumes placebo. In this research, placebo refers to placebo capsules containing 350 milligram of dry bread, which are three daily during the first three days of menstruation that These capsules were prepared in the Faculty of Pharmacy, which were similar to the capsules of the Ziziphora tenuior plant extract in terms of color, smell, shape and size and the capsule of Ziziphora tenuior plant extract and the placebo capsule are both placed next to each other due to the similarity of the smell and will be provided to the samples in the same packaging. 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 further information.
public Fateme Azarialikhanghaleh
Niayesh Campus Dormitory (Al-Zahra), in front of Shahid Rajaei Hospital, Niayesh Intersection, Valiasr Street
Tehran Iran (Islamic Republic of) 1996835119 +98 21 8877 9546 fateme.azari@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Fateme Azarialikhanghaleh
Niayesh Campus Dormitory (Al-Zahra), in front of Shahid Rajaei Hospital, Niayesh Intersection, Valiasr Street
Tehran Iran (Islamic Republic of) 1996835119 +98 21 8877 9546 fateme.azari@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Have no children Participants must be between the ages of 18 and 30. Be Iranian According to the statement of the person suffering from a known chronic disease such as Diabetes, Hypertension, Underlying heart disease, Infectious disease, liver disease, kidney disease, Epilepsy and Malignancy She has not taken any medication since three months before the intervention. Do not use special drugs or supplements According to the person's statement, she does not have any symptoms such as burning, itching or abnormal secretions from the Vagina and Cervix Have regular cycles from 22 to 35. Body mass index should be between 19.8 and 26. Have a history of primary dysmenorrhoea according to the Visual analog scale during the last 6 months Students living in Shahid Beheshti Medical Sciences student dormitories in Tehran The amount of bleeding should be between 3 and 7 days No bleeding between periods. There should be no stressful events such as the death of relatives and surgery in the last 6 months. Do not smoke or drink alcohol. There is no history of Uterine disorders (Myoma, Bicornuate uterus, Polyps), Ovarian disorders (Ovarian Cyst and Polycystic ovary) or Endometrial hypertrophy and Endometriosis according to recent ultrasounds. 18 years 30 years Female Take any herbal medicine while studying. Participants do not want to continue treatment. Kidney or liver disease or cases that, according to the doctor's opinion, should stop treatment, appear during the research. Failure to correctly use Ziziphora tenuior capsules or placebo, less than 7 capsules in the first three days of menstruation. Treatment - Drugs Placebo Intervention group: In this study, the intervention group consumes the oral capsule of Ziziphora tenuior plant extract. In this research, the Ziziphora tenuior plant was collected from the authentic perfumers of Bojnoord city, North Khorasan province, and it was confirmed by the respected botanist of the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences. Half a gram of extract is obtained from every 10 grams of dried leaves of this plant, and each capsule contains 350 milligram of Ziziphora tenuior extract. The capsule will be prepared in collaboration with the pharmacology specialist of the Faculty of Pharmacy of Shahid Beheshti University of Medical Sciences, which is prescribed in two cycles and in three divided doses every 8 hours during the menstrual cycle. Control group: In this study, the control group consumes placebo. In this research, placebo refers to placebo capsules containing 350 milligram of dry bread, which are three daily during the first three days of menstruation that These capsules were prepared in the Faculty of Pharmacy, which were similar to the capsules of the Ziziphora tenuior plant extract in terms of color, smell, shape and size and the capsule of Ziziphora tenuior plant extract and the placebo capsule are both placed next to each other due to the similarity of the smell and will be provided to the samples in the same packaging. Primary dysmenorrhea. Timepoint: before the intervention and after the end of the intervention, after each menstrual cycle in two consecutive cycles. Method of measurement: Visual Analogue Scale. Systemic symptoms associated with primary dysmenorrhea. Timepoint: Before the intervention and after the end of the intervention, after each menstrual cycle in two consecutive cycles. Method of measurement: Verbal multidimensional scoring system. Shahid Beheshti University of Medical Sciences Approved 2024-04-29 Research Ethics Committees of School of Pharmacy and Nursing & Midwifery of Shahid Beheshti Universi Faculty of Nursing and Midwifery, in front of Shahid Rajaei Heart Hospital, Niayesh Intersection, Waliasr Street Tehran Tehran Iran (Islamic Republic of)