Efficacy, safety and economic evaluation of Dangguijagyak-san for primary dysmenorrhea; a randomized, double-blind, parallel-group, multi-center, investigator-initiated clinical trial

Kyung Hee University Oriental Medicine Hospital at Gangdong0 个研究点目标入组 240 人开始时间: 待定最近更新: 2019年11月5日

适应症

试验速览

暂无简介。

•The inclusion criteria are: (1) reproductive-age female aged = 18 and = 40 years; (2) suffering from primary dysmenorrhea; (3) suffering from menstrual pain within recent three consecutive months and average VAS = 50 mm during run-in period; (4) being provided with the details of this trial, understanding the details completely, willing to participate voluntarily, and being offered written informed consent to follow the precautions.

•The exclusion criteria are: (1) women suffering from secondary dysmenorrhea due to pelvic pathology such as uterine fibroids, adenomyosis, endometriosis, or pelvic inflammatory diseases; (2) lactating, being pregnancy, intend to be pregnant, or have possibility of pregnancy (human chorionic gonadotropin test positive); (3) with intrauterine devices; (4) metrorrhagia with menstrual cycles less than 21 days or oligomenorrhea with cycles over 40 days; (5) have administered oral contraceptives or other hormonal treatments within recent three months; (6) twice higher liver enzymes (alanine transaminase or aspartate transaminase) than the reference values of study sites; (7) 1.5 times higher blood urea nitrogen or creatinine than the reference values of study sites; (8) have depressive or anxiety disorders, or administrating psychiatric medications such as antidepressants; (9) have participated in other clinical trials within recent one month; (10) have been treated with Chinese herbal medicines or alternative therapies for primary dysmenorrhea within recent three months; (11) judged inadequate by investigators.

发起方

Kyung Hee University Oriental Medicine Hospital at Gangdong