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Clinical application and mechanism of niacin skin flushing in chronic constipation

Clinical application and mechanism of niacin skin flushing in chronic constipation

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200061037
Enrollment
Unknown
Registered
2022-06-15
Start date
2022-06-01
Completion date
Unknown
Last updated
2023-03-26

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

Conditions

chronic constipation

Interventions

Case series:None

Sponsors

Jiangsu Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Observation group: 1. Aged 18-75 years; 2. Patients consistent with the diagnosis of chronic constipation: (1) Reduced frequency of defecation, dry and hard stool and/or constipated stool. Reduced bowel movements: fewer than 3 bowel movements per week; Difficult defecation: laborious defecation, difficult discharge, undrained feeling, time-consuming defecation and manual assistance; (2) Symptoms of constipation have been present for at least 6 months; (3) Supplementary diagnostic criteria for non-depression: Subjects underwent PHQ-9 depression screening scale, if >= 5 points to psychological outpatient department, and Hamilton Depression Scale, if >= 7 points, will not be included. Healthy control group: 1. Aged 18-75 years; 2. No symptoms of constipation; 3. The weight of male subjects should not be less than 50kg, and that of female subjects should not be less than 45kg. Body mass index (BMI) = weight (kg)/height 2 (m2), BMI within the range of 18-28 kg/m2 (including the critical value); 4. Normal or abnormal physical examination and vital signs have no clinical significance.

Exclusion criteria

Exclusion criteria: 1. Vitamin drug allergy; 2. Gastrointestinal tumor, inflammatory bowel disease, history of abdominal surgery, diseases of endocrine system; 3. Depression, anxiety and other mental diseases, brain trauma, brain tumors; 4. Alcohol, smoking or drug addiction; 5. Oral administration of non-steroidal anti-inflammatory drugs, steroids, probiotics or prebiotics and antibiotics within two weeks; 6. Severe allergies, autoimmune diseases, severe skin diseases; 7. Pregnancy or lactation; 8. The Investigator believes that there are any other reasons why the subject is not suitable for the study.

Design outcomes

Primary

MeasureTime frame
niacin skin flushing;

Countries

China

Contacts

Public ContactFeng Ye

Department of Gastroenterology, the First Affiliated Hospital of Nanjing Medical University

fengye@njmu.edu.cn+86 13815897873

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026