Evaluation effectiveness of topical ginger oil pad in dysmenorrhea: Triple blind-placebo-controlled Randomized Clinical Trial

Evaluation of the effectiveness of topical ginger oil pad in dysmenorrhea

Triple-blind randomized clinical trial, with control group, parallel, phase 3 on 30 patients, Permuted Block Randomization method

The location of the project will be Ahmadieh Health Center affiliated with the Faculty of Persian Medicine of Tehran University of Medical Sciences. After finding eligible cases, and taking a written consent form, all participants will be assigned to two study groups, intervention, and control, using a random allocation method. In the following, similar pockets containing the pad will be given to each group. Researchers, volunteers, outcome assessors, and statistical data analysts do not have any information about drugs and placebo groups

Inclusion criteria: Age 15 to 45 years old, BMI(body mass index)≤35, regular menstruation at intervals of 21 to 35 days and regular bleeding for 3 to 10 days at least in the last 3 months, moderate and severe dysmenorrhea؛ Exclusion criteria: Pregnancy, history of secondary dysmenorrhea, history of abdominal or pelvic surgery, taking other medications, history of skin allergies to ginger

Intervention group: Receive 3 pads containing ginger oil in each menstrual cycle (2 cycles), change the pad every 48 hours, place the pad under the umbilicus and above the pubic area, take one mefenamic acid capsule if they have pain no later than one hour after Use the pad. control group: Receive 3 placebo pads in each menstrual cycle (2 cycles), change the pad every 48 hours, place the pad under the umbilicus and above the pubic area, take one mefenamic acid capsule if they have pain at most one hour after using the pad.

pain intensity؛ pain duration؛ Patient satisfaction with treatment؛ Physician satisfaction with treatment

The study subjects are assigned to one of the intervention and control groups by Permuted Block Randomization method by random sampling method from one of the numbers 1 to 6 using SPSS software. Numbers 1 to 6 are specific codes of each sequence BBAA, AABB, ABAB, BABA ABBA, BAAB. according on selected sequence, each group of four-subject receives one of the intervention and control methods.

The medicine and placebo group will receive similar pads in shape and size and in the same packages labeled with codes A and B. The patient and the researcher prescribing the drug and analyzing the data are not aware of the meaning of the codes. The results of the study are reviewed by a researcher who is not aware of the grouping and is blind to the groups and the type of drug.