None listed
Conditions
Interventions
Drug : The selected subjects visit within 2 weeks of the screening visit and are randomly assigned to either the Eulja-tang group or the
Daehwangmokdanpitang group at a 1:1 ratio.
Randomly assigned
Sponsors
Daejeon Korean Medicine Hospital of Daejeon University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men and women between the ages of 19 and 65 2) Patients diagnosed with functional constipation according to Rome IV diagnostic criteria 3) Patients with grade 1 or grade 2 according to Goliger classification 4) Those who voluntarily agreed in writing to participate in this clinical trial
Exclusion criteria
Exclusion criteria: 1) Those with a history of using constipation treatment drugs (bulking laxatives, stool softeners, dietary fiber products, etc.), constipation-inducing drugs, enemas and suppositories, and hemorrhoids ointment within the last 2 weeks 2) Those who have received oriental medical treatment such as acupuncture, moxibustion, cupping, or herbal medicine for the purpose of treating constipation or hemorrhoids within the last 2 weeks 3) Those with a Sodergren score of 6 or higher or those with a grade 3 or higher according to Goligher's classification which are eligible for surgery 4) Metabolic disease (hypothyroidism, diabetes, hypercalcemia, etc.), myopathy (amyloidosis), nervous system disease (Parkinson's disease, multiple sclerosis, spinal cord injury, etc.), constipation or drug-induced constipation due to underlying diseases such as depression is suspected one who becomes 5) In case of acute abdominal disease (appendicitis, intestinal bleeding, ulcerative colitis, etc.), intestinal obstruction, intestinal stenosis, or severe gastrointestinal symptoms, or an anal disease accompanied by dentition, fistula, perianal abscess, anal pruritus, anal Crohn's disease, etc. 6) Those who have been diagnosed with inflammatory bowel disease or an organic disease (colon cancer, etc.) within 6 months or have the following warning symptoms or signs within 3 months: Bloody stools accompanied by anemia not considered to be the cause of hemorrhoids or hemorrhoids, recently those who have lost 5% or more of their total body weight in 3 months, constipation within 3 months 7) Those with a history of abdominal surgery (except for appendectomy, hernia surgery, cholecystectomy, cesarean section) 8) Those who have had hemorrhoid surgery within 12 months prior to screening 9) Clinically significant diseases and disorders in the liver, kidney, cardiovascular system, respiratory system, endocrine system, and central nervous system in physical examination and clinical examination, or cerebrovascular disease (cerebral infarction, cerebral hemorrhage) within 6 months before screening; Those with a history of heart disease (angina pectoris, myocardial infarction, heart failure, etc.), severe nervous system disease, kidney disease, immunodeficiency disease, active hepatitis B or C, active tuberculosis, asthma, COPD, malignancy or mental illness 10) Patients with hepatic and renal dysfunction (at screening, ALT, AST, r-GTP = 3 times the upper limit of normal, blood creatinine = 2 times the upper limit of normal) 11) Uncontrolled diabetic patients (glycated hemoglobin level 9% or higher or fasting blood sugar 160mg/dL or higher at screening) 12) With abnormal Free T4 on the thyroid function test, TSH 5.1 uIU/ml at screening 13) Those who have a history of hypersensitivity to the components of the drug for clinical trials 14) Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 15) A person with a history of alcoholic or drug abuse 16) Pregnant, lactating, or planning to become pregnant within 3 months 17) Those who participated in other clinical trials taking clinical investigational drugs within 30 days before participation in this clinical trial (based on the date of written consent) 18) In case the investigator judges that it is not suitable for the clinical trial for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of bleeding | — |
Secondary
| Measure | Time frame |
|---|---|
| Bleeding severity score | — |
Countries
Korea, Republic of
Contacts
Public ContactHesol Lee
Daejeon Korean Medicine Hospital of Daejeon University
Outcome results
None listed