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Clinical Trials/KCT0003005
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

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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
6 years ago
Study Type
Interventional Study
Sex
Female

Investigators

Sponsor
Kyung Hee University Oriental Medicine Hospital at Gangdong

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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