Functional constipation
Conditions
Interventions
Experimental Group:Biantong Capsule + Qihuang Tongmi Soft Capsule Placebo (Biantong Capsule: 3 capsules orally, twice daily
Qihuang Tongmi Soft Capsule Placebo: 3 capsules orally, twice daily)
Rescue treatment with glycerin enema (if no bowel movement for >4 consecutive days)
Control Group:Qihuang Tongmi Soft Capsule + Biantong Capsule Placebo (Biantong Placebo: 3 capsules orally, twice daily
Qihuang Tongmi Soft Capsule: 3 capsules orally, twice daily)
Sponsors
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Meet the Rome IV diagnostic criteria for functional constipation; patients with internal hemorrhoids must meet the diagnostic criteria for grade I, II, or III internal hemorrhoids; (2) Have fewer than 3 complete spontaneous bowel movements (CSBM) per week; (3) Meet the traditional Chinese medicine diagnostic criteria for spleen and kidney deficiency, intestinal qi stagnation syndrome; (4) Aged 18-80 years (inclusive); (5) Signed informed consent.
Exclusion criteria
Exclusion criteria: (1) Constipation caused by intestinal diseases (e.g., colon tumors, intestinal stenosis/obstruction), systemic diseases (e.g., Parkinson's disease, stroke, hypothyroidism, systemic sclerosis, amyloidosis, dermatomyositis), medications (e.g., long-term use of opioids, anticholinergics), or excess-heat constipation; (2) Presence of colon polyps >2 cm, electrolyte imbalances (e.g., hypokalemia, hypomagnesemia, hypercalcemia), or laxative dependence (=3 times/week for =1 month); (3) Poorly controlled hypertension (systolic =180 mmHg and/or diastolic =110 mmHg) or diabetes (HbA1c >8.5%) despite regular treatment; (4) Colorectal surgery within the past month; (5) Severe primary diseases of heart, brain, liver, kidney, endocrine, or hematopoietic systems; malignancy; psychiatric disorders (e.g., severe depression, anxiety, schizophrenia); (6) ALT/AST >2×ULN; serum creatinine >1.5×ULN; (7) Bedridden patients; (8) History of alcoholism or substance abuse; (9) Coagulopathy, active bleeding, acute abdominal inflammation/perforation, or other colonoscopy contraindications; (10) Pregnant, planning pregnancy, or lactating women; (11) Allergy to study drugs or rescue medications; (12) Participation in other drug trials within the past 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall CSBM Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of Patients with CSBM within 24 Hours of Treatment;Average CSBM Duration at Weeks 4, 8, and 12;CSBM Frequency at Weeks 4, 8, and 12;Change in Stool Consistency Score (Bristol Stool Scale) at Weeks 4, 8, and 12;Change in Straining Score (Likert Scale) at Weeks 4, 8, and 12;Total Effective Rate of TCM Syndrome at Week 8;Change in TCM Syndrome Score at Week 8;Disappearance Rate of Individual TCM Symptoms at Week 8;Improvement Rate in Frailty (Fried Frailty Scale) at Week 8 (for elderly frail patients only);Rescue Medication Usage Rate at Weeks 4, 8, and 12;Change in EQ-5D-5L Score at Week 8; | — |
Countries
China
Contacts
Public ContactZhang Shengsheng
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Outcome results
None listed