None listed
Conditions
Interventions
Drug : Test drug (Good Morning S granule)
1) Product name and manufacturer: Good Morning S granule, Han-poong Pharmaceutical Co., Ltd.
2) Appearance: Brown granule
3) Content: 4.8 g/pouch
4) Usage and
Sponsors
Hanpoong Pharm & Foods
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Men and women aged 19 or older and under 75 years of age; (2) A person with symptoms of functional constipation in accordance with the ROME IV (2016) criteria; 1) If the following symptoms are at least 6 months in advance and there are more than 2 symptoms in the last 3 months (ROME IV criteria) ? Excessive force cycle during bowel movements is at least 25% of the total number of bowel movements. ? A lumpy or hard stool has more than 25% of the total number of defecations. ? If there is more than 25% of the total number of bowel movements after bowel movements. ? In case of bowel movement, the sense of anus closure is greater than 25% of the total number of bowel movements. ? If manual manipulation is required to help defecate, there is at least 25% of the total number of defecation cases. ? bowel movements less than three times a week 2) Little dilute bowel movement (3) A person who takes and takes constipation pills and has experienced abdominal pain; (4) A person who has agreed to participate in this clinical trial and has signed a written consent form prior to the commencement of the examination;
Exclusion criteria
Exclusion criteria: (1) Those who have a history of severe malignant tumors, nervous system diseases, kidney diseases, cerebrovascular diseases (brain infarction, cerebral hemorrhage), heart disease (sympathy, myocardial infarction, heart failure, arrhythmia, and arrhythmia requiring treatment) may participate in the test according to the tester's judgment. (2) A person with acute abdominal disease (a appendicitis, intestinal hemorrhage, ulcerative colitis), intestinal obstruction, intestinal adhesion, or severe gastrointestinal symptoms; (3) A person who has any warning symptoms or signs of warning of enteritis or a substrate disease; (Warning symptoms: ? First symptom since age 50, ? accompanied by weight loss, ? hematuria, ? fever, ? night symptoms (sleeping), ? progressive swallowing Gonnan, ? colon cancer, family history of inflammatory bowel disease, ? sustained diarrhea, ? severe chronic constipation) (Warning Signs: ? Proof of Bloodlust, ? Anemia, ? Abdominal mass, ? Signs of intestinal obstruction, ? Signs of Absorption Disorder, ? Signs of thyroid dysfunction, ? Active Arthritis, ? Dermatitis Herpetiformis or Pyoderma gangrenosis skin lesions) (4) A person with constipation (Parkinson's disease, multiple sclerosis, diabetes, etc.) due to underlying diseases; (5) A person who has a history of abdominal surgery except appendectomy, hernia surgery, cholecystectomy, and caesarean section. (6) A person who has genetic problems such as galactose intolerance, Lap galactose intolerance, Lap lactase deficiencies, or glucose ·galactose malabsorptivity, etc. (7) Unregulated thyroid disease patients (8) Patients with unregulated high blood pressure (at least 160mmHg of retractor blood pressure or at least 100mmHg of relaxation period blood pressure, after 10 minutes of stabilization of clinical trial) (9) A person who is pregnant, breast-feeding, or planning to conceive within three months; (10) A person who has participated in another interventional clinical trial (including a human application test) or plans to participate in another interventional clinical trial (including a human application test) since the beginning of this clinical trial within one month of visit 1. (11) A person allergic to the ingredients of this clinical trial clinical trial medication. (12) Those who had no effect when taking constipation drugs, such as dietary fiber, volumetric laxatives, or fecal softener, etc. (13) A person who the tester deems inappropriate for this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number and form of defecation | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of stomachaches, strength, and duration;Clinical symptoms (abdominal spasms, abdominal pain, abdominal cramps, borborygmus, feeling residual after defecate, inclination for stool, number of farts;the time from the first dose to the first bowel movement;Short Form-36;improvement assessment;improvement rate;elimination rate;adverse event;vital sign(blood pressure, pulse);body measurement(body weight) | — |
Countries
Korea, Republic of
Contacts
Public ContactDONGHO LEE
Seoul National University Bundang Hospital
Outcome results
None listed