Efficacy and Safety of nF1; A 8 week, Multi center, Randomized, Double-blind, Placebo-Controlled Clinical Trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0002867

Enrollment

111

Registered

2018-05-15

Start date

2018-03-13

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : Subjects will be randomized to receive nF1 40mg or nF1 100mg or placebo. Subjects will orally self-adminster nF1 40mg or nF1 100mg or placebo twice, 2 packs per day for 8weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) All men and women aged between 20 and 75 years 2) The subject, whose symptoms of the disease manifested before at least 6 month, in the last 3 months. Also, more than two of the followings that apply to oneself. ? Straining during more than 25% of defecations ? Lumpy or hard stools in more than 25% of defecations ? Sensation of incomplete evacuation for more than 25% of defecations ? Sensation of anorectal obstruction/blockage for more than 25% of defecations ? Manual maneuvers to facilitate more than 25% of defecations (e.g., digital evacuation, support of the pelvic floor) ? Fewer than three defecations per week

Exclusion criteria

Exclusion criteria: 1) Subjects who underwent abdominal surgery (except, appendectomy, Caesarian section, herniotomy) 2) IBS-C: irritable bowel syndrome with constipation(According to Rome IV diagnostic criteria)

Design outcomes

Primary

Measure	Time frame
Number of defecation and stool type	—

Secondary

Measure	Time frame
Calprotectin;Adverse Event	—

Countries

Korea, Republic of

Contacts

Public ContactJoo Kim

Seoul National University Hospital

jooskim@snuh.org+82-2-2072-2156

Outcome results