]>
IRCT20250803066739N1 IRCT 2025-09-19 Shahre-kord University of Medical Sciences The effect of Pelargonium graveolens Capsules on the severity of menstrual pain in female students. "Investigating the Effects of Pelargonium graveolens Soft Capsules on the Severity of Primary Dysmenorrhea in Students of Islamic Azad University, Shahrekord: A Randomized Clinical Trial 2025-09-06 anticipated 72 Complete https://irct.ir/trial/85317 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Blinding will be performed in a triple-blind manner, with blinding of participants, the research team, and individuals involved in data analysis. The geranium and placebo capsules will be identically prepared by Barich Essential Oils Company and will be labeled A and B. Due to the blinding of the study, the contents of A and B will remain unknown to the research team, the study samples, and the data analyst until the study is completed, and they will not know the nature of the capsules. A limited random allocation method will be used for randomization. For this purpose, 36 cards labeled A and 36 cards labeled B will be mixed together and placed in an envelope, and one card will be drawn at random for each research unit. The label of the drawn card will indicate the treatment intervention group and will be recorded, Blinding description: Blinding will be performed in a triple-blind manner, with blinding of participants, the research team, and individuals involved in data analysis. The geranium and placebo capsules will be identically prepared by Barich Essential Oils Company and will be labeled A and B. Due to the blinding of the study, the contents of A and B will remain unknown to the research team, the study samples, and the data analyst until the study is completed, and they will not know the nature of the capsules. 3 Primary dysmenorrhea. Intervention group: The intervention group received 50 mg soft capsules of fragrant geranium essential oil standardized based on 15 to 22 mg of citronellol (manufactured by Barich Essential Oils) twice a day after meals for 2 consecutive cycles (76). The control group also received placebo capsules containing base oil (in the same shape and packaging as the fragrant geranium soft capsules) and ordered from Barich Essential Oils. Participants in both groups were given 250 mg capsules of mefenamic acid and were instructed to use mefenamic acid capsules every 8 hours if pain was not controlled by geranium and placebo capsules and to record the number of capsules consumed in a daily checklist.. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information available.
public Faranak Safdari
Rahmatieh Shahrekord University of Medical Sciences
Shahrekord Iran (Islamic Republic of) 8813833435 +98 38 3334 1216 faranaksafdari@gmail.com Shahre-kord University of Medical Sciences scientific Azam Motamedi
Rahmatieh Shahrekord University of Medical Sciences
Shahrekord Iran (Islamic Republic of) 8813833435 +98 38 3334 1216 Azam.mtmd@gmail.com Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Having moderate to severe primary dysmenorrhea (score equal to or greater than 4 on the visual analog scale), being single, being students between 18 and 25 years old (the age group with the highest incidence of PD and the most severe clinical manifestations), having a regular menstrual cycle of 21 to 35 days, and willingness to participate in the study. 18 years 25 years Female Medical students at Shahrekord Azad University with primary dysmenorrhea, a history of regular exercise, consumption of any herbal tea, any known physical disease, any known psychological disease, consumption of any medication (chemical or herbal and hormonal), addiction to cigarettes, alcohol and similar things, allergy to medicinal herbs. N94.4Prima Pain and other conditions associated with female genital organs and menstrual cycle Treatment - Other Intervention group: The intervention group received 50 mg soft capsules of fragrant geranium essential oil standardized based on 15 to 22 mg of citronellol (manufactured by Barich Essential Oils) twice a day after meals for 2 consecutive cycles (76). The control group also received placebo capsules containing base oil (in the same shape and packaging as the fragrant geranium soft capsules) and ordered from Barich Essential Oils. Participants in both groups were given 250 mg capsules of mefenamic acid and were instructed to use mefenamic acid capsules every 8 hours if pain was not controlled by geranium and placebo capsules and to record the number of capsules consumed in a daily checklist. Percentage of students with severe primary dysmenorrhea in the two groups. Timepoint: Before the start of the intervention, one month after the end of the intervention, and two months after the end of the intervention. Method of measurement: Visual Analogue Pain Scale. Quality of primary dysmenorrhea in two groups. Timepoint: Before the start of the intervention, one month after the end of the intervention, and two months after the end of the intervention. Method of measurement: McGill Pain Questionnaire Short Form. Shahre-kord University of Medical Sciences Approved 2025-06-29 Ethics Committee of Shahrekord University of Medical Sciences Research and Technology Deputy, Shahrekord University of Medical Sciences, Kashani Street, Shahrekord, Iran Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)