A randomized, double blind, placebo-controlled, crossover study to evaluate the effectiveness of topical application of Go-Go YIN oil blend on relieving the symptoms of Primary dysmenorrhea

GODS OWN STORE0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Participants must be single females, aged 18-20 years old with regular cycles lasting three to seven days. Subjects must have a negative pregnancy test. Pregnant patients or individual with history of pregnancy will be excluded from the study.
•2.Subjects suffering from primary dysmenorrhea with a pain level >5 (severe pain) on a visual analogue scale and are not undergoing treatment for the pain.
•3.The menstrual discomfort experienced should not be due to secondary dysmenorrhea and the Subjects should not be suffering from any systemic or gynaecologic disorders.
•4.Participants should be willing to sign a written consent for participation in the study and undergo a baseline interview.
•5.Participants must be willing to commit to medication dosing and assessment visits for evaluation.
•6.Participants must be willing to refrain from taking analgesics from the outset of the study until second phase evaluation (if patient force to take allopathic medicine, subject will be dropped from the study).
•7.Participants must agree that during the study they will refrain from taking any new herbal supplement and prescription or non-prescription medications without prior approval of the research team.
•8.Participants must agree to take healthy diet and life style

•1.Participants with known or suspected secondary dysmenorrhea (major abdominal or pelvic surgery, endometriosis, pelvic inflammatory disease (PID), ovarian cysts, pathological vaginal secretion, chronic abdominal pain, inflammatory bowel disease, and irritable bowel syndrome).
•2.Single or married subjects who are pregnant or have borne children.
•3.Participants with a history of or current any kind of hormonal therapy during the last 6 months.
•4.Participants with evidence or history of significant systemic or gynecological disorder. (People with hypothyroidism who are on adequate and stable thyroid replacement will not be excluded).
•5.Participants weighing less than 50 kg and malnourished.
•6.Patients reporting use of analgesics during the study period.
•7.Participant with known allergies to the main components of the test product or placebo.
•8.Any participant who is not able to give adequate informed consent.

发起方

GODS OWN STORE