Chronic constipation
Conditions
Interventions
Aurantii fructus immaturus flavonoid extract tablets 3-tablet (t.i.d.) Group:Three tablets of aurantii fructus immaturus flavonoid extract tablets were administered orally, three times daily, with war
Aurantii fructus immaturus flavonoid extract tablets 6-tablet (t.i.d.) Group:Six tablets of aurantii fructus immaturus flavonoid extract were administered orally, three times daily, with warm water ha
Aurantii fructus immaturus flavonoid extract tablets 6-tablet (b.i.d.) Group:Six tablets of aurantii fructus immaturus flavonoid extract were administered orally, twice daily, with warm water half an
Sponsors
The First Hospital of Hunan University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1.Voluntary participation with signed informed consent. 2. Male or female subjects aged = 18 years. 3. Patients with chronic constipation characterized by spontaneous bowel movements of < 3 times per week, with a disease course lasting 3 months or longer. 4. Hard or lumpy stools are defined as Type 1 or Type 2 on the Bristol Stool Form Scale, occurring in at least 25% of defecations.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. Known allergy or contraindication to the investigational drug. 2. Presence of current, unexplained, and clinically significant alarm symptoms. 3. Patients with mental disorders or intellectual/language impairments that preclude them from completing questionnaires or self-recording symptoms. 4. Constipation caused by intestinal diseases such as colon tumors, luminal stenosis, or obstruction. 5. Drug-induced constipation. 6. Other subjects deemed by the investigator as inappropriate for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete spontaneous bowel movement response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bowel Movement Frequency (Complete Spontaneous Bowel Movement, Spontaneous Bowel Movement) in the Three Dose Groups of Aurantii fructus immaturus flavonoid extract tablets;Stool Consistency;Time to First Spontaneous Bowel Movement (SBM) / Complete Spontaneous Bowel Movement (CSBM); | — |
Countries
China
Contacts
Public ContactYin Xu
The First Hospital of Hunan University of Chinese Medicine
Outcome results
None listed