KCT0003005
Recruiting
未知
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 sites240 target enrollmentTBD
ConditionsDiseases of The genitoruinary system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of The genitoruinary system
- Sponsor
- Kyung Hee University Oriental Medicine Hospital at Gangdong
- Enrollment
- 240
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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