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The goal of this clinical trial is to investigate drinking effect of electrolyzed hydrogen-rich alkaline reduced water (EHARW) in chronic constipation patients. The main question is that drinking EHARW will improve the symptoms of chronic constipation for 4 weeks.
Participants will drink EHARW (20 mL/kg of body weight/day) generated from the experimental device for 4 weeks.
Patients diagnosed with constipation will be recruited and screened according to the inclusion and exclusion criteria after sign in the informed consent form. The selected patients will be enrolled. The experimental device (BTM-1200, Bion-Tech, Gyeonggi-do, Korea) will be installed at each patient's house. The researcher will instruct patients drinking method. The patients will drink a total of 20 mL/kg of body weight/day of EHARW (pH 9.5) in 3-different times, and drink directly from the device on an empty stomach for 4 weeks. The clinical trial is conducted in a single group without a control group, and the efficacy is evaluated by comparing the symptoms of constipation pre- and post-intervention. The primary outcome is the proportion of responders based on frequency of complete complete spontaneous bowel movement (CSBM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EHARW Treatment group | Experimental | The experimental group will drink a total amount of 20 mL/ kg body weight/day of EHARW for 4 weeks on an empty stomach according to the researcher's instruction. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electrolyzed Alkaline Ionizer | Device | Patients will drink EHARW calculated by 20 mL/kg body weight/day which can be divided into several times a day for drinking. The patient is recommended to drink water in an empty stomach and to drink water generated from the device as soon as possible. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete spontaneous bowel movement (CSBM) frequency | CSBM is used to access the frequency of bowel movement. This indicates the efficacy of EHARW (pH 9.5) after 4-weeks of treatment in chronic constipation patients. | 4 weeks treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Bristol stool scale score | Fecal form is accessed by using Bristol stool scale. Fecal form indicate hardness of stool. Higher score present improvement of constipation symptoms. Similarly other questionnaires using self observation diary was also assessed including straining at defecation, stiffness of the stool, sensation of incomplete evacuation, and sensation of obstruction. | 4 weeks treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyu-Jae Lee, Ph.D. | Department of Convergence Medicine, Wonju College of Medicine, Yonsei University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wonju College of Medicine | Wŏnju | Ganwon-do | 26426 | South Korea |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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comparison between baseline and post-treatment in single group
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No need of blinding
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| Patient assessment of constipation-symptoms (PAC-SYM) Questionnaire | PAC-SYM is used to access constipation symptoms of patient before and after the intervention. This tool is categorized into 3 (abdominal, rectal, stool), and includes total 12 questions. Higher score present improvement of constipation symptoms. | 4 weeks treatment |
| Patient assessment of constipation-quality of life (PAC-QOL) Questionnaire | PAC-QOL is used to access constipation-related quality of life before and after the intervention. This tool is categorized into 4: physical discomfort, psychological discomfort, worries and satisfaction, and consists of 28 questions. Higher score present improvement of constipation symptoms. | 4 weeks treatment |