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Clinical Trials/KCT0006050
KCT0006050
Completed
未知

Metabolomics approach for evaluating effect of herbal medicines for female infertility (subtitle: Metabolic alterations after Dangguijakyaksan administration in women with mild menstrual pain)

Daegu Haany University0 sites36 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
Daegu Haany University
Enrollment
36
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
April 27, 2021
Last Updated
4 years ago
Study Type
Interventional Study
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • 1\) Women of childbearing age over 19
  • 2\) Those who are within 20% of the ideal weight calculated by Broca's formula
  • 3\) Those with regular menstrual cycles (within 28 days ± 7 days)
  • 4\) Those who complain of primary dysmenorrhea with mild (visual analog scale (VAS) less than 40mm) for at least 6 months during screening
  • 5\) Medically without congenital or chronic disease
  • 6\) Those who are judged to be suitable for the subject through medical examination (typical items such as interview, blood pressure, physical examination, blood test, blood chemistry test, urine test, serum test, etc.)
  • 7\) Among applicants who are highly likely to become pregnant, those who are not pregnant by the pregnancy test at the time of medical examination, and those who use medically acceptable contraception other than hormonal contraception until the end of the study
  • 8\) Applicants who can participate in the entire clinical trial process
  • 9\) A person who has fully explained the purpose, content, and drug of the clinical trial for this clinical trial, and a person who decides to participate in the clinical trial and gives written consent.

Exclusion Criteria

  • 1\) Those who refuse written consent or do not have the ability to consent in writing
  • 2\) Pregnant or lactating women
  • 3\) Persons who use hormonal contraception among medically acceptable birth control methods (e.g., implanon, intrauterine device insertion (e.g., mirena), oral contraceptives)
  • 4\) Those who have undergone gastric acid secretion suppression surgery or gastric or esophageal surgery that may affect the absorption of clinical trial drugs (except for simple perforation, appendectomy, and cholecystectomy)
  • 5\) Those with gastrointestinal diseases (Crohn's disease, ulcers, acute/chronic pancreatitis) that may affect the absorption of investigational drugs
  • 6\) Those who have been diagnosed with clinically significant systemic diseases (liver, kidney, nervous system, respiratory system, cardiovascular system, urinary system, endocrine system), malignant tumor, or mental illness.
  • 7\) Those who fall under frequent menstruation (period less than 21 days) or rare menstruation (period exceeding 35 days)
  • 8\) Those who showed clinical abnormalities in the screening test, especially those who showed the following test results
  • Hemoglobin \<11\.0 g/dL
  • AST or ALT value exceeds 1\.5 times the upper limit of the laboratory's normal range

Outcomes

Primary Outcomes

Not specified

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