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Observation on the clinical efficacy of Shouhui Laxative Capsule in the treatment of chronic heart failure complicated with constipation in the elderly (qi and yin deficiency syndrome).

Observation on the clinical efficacy of Shouhui Laxative Capsule in the treatment of chronic heart failure complicated with constipation in the elderly (qi and yin deficiency syndrome).

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400082934
Enrollment
Unknown
Registered
2024-04-11
Start date
2024-04-11
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

Constipation and heart failure

Interventions

Experimental group:Shouhui Laxative Capsule

Sponsors

ZhuJiang Hospital of Southern Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients who meet the diagnostic criteria for chronic heart failure and have a pattern differentiation of qi and yin deficiency syndrome in traditional Chinese medicine; 2. Patients with cardiac function grade I-III; 3. Patients who meet the diagnostic criteria for constipation, have a syndrome differentiation of qi and yin deficiency in traditional Chinese medicine, and constipation occurs after the diagnosis of heart failure; 4. The primary diseases that cause heart failure are coronary heart disease, hypertensive heart disease, pulmonary heart disease, dilated cardiomyopathy, hypertrophic cardiomyopathy, etc. 5. Age between 60-80 years old, gender is not limited; 6. Those who have signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Combined with severe valvular disease, pericardial disease, congenital heart disease, cardiogenic shock, severe myocarditis, malignant arrhythmia, rheumatic heart disease; 2. Patients with pulmonary hypertension, severe chronic obstructive pulmonary disease, acute asthma exacerbation, and severe pulmonary infection; 3. Severe liver disease (ALT= 3 times the upper limit of normal), kidney disease (Cr=3mg/dl or >265µmol/L), hematologic disease, diabetes mellitus with serious complications, severe endocrine disease; 4. Suffering from acute inflammatory bowel disease (ulcerative colitis, Crohn's disease), intestinal obstruction or incomplete intestinal obstruction, perforation of the digestive tract, appendicitis, unexplained abdominal pain, acute abdomen; 5. Patients with malignant tumors; 6. Those with allergies, or allergies to a variety of drugs and foods, or those who are known to be allergic to the ingredients of Shouhui Laxative Capsules; 7. Patients who cannot take oral capsule preparations; 8. Those who have participated in other clinical studies within three months; 9. Those who are suspected or confirmed to have a history of alcohol or drug abuse; 10. Those with a recent history of acute cerebrovascular disease, major surgery and trauma; 11. Those who have taken laxative drugs within 1 week before enrollment.

Design outcomes

Primary

MeasureTime frame
The effectiveness of clinical symptoms of constipation;

Secondary

MeasureTime frame
Constipation clinical symptom score;NYHA classification;Six-Minute Walk Test;NT-proBNP;Inflammatory index;Heart failure efficacy score;TCM symptom efficacy score;

Countries

China

Contacts

Public ContactDonghui Liang

ZhuJiang Hospital of Southern Medical University

cjygzucm@163.com+86 131 8909 7991

Outcome results

None listed

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