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The safety and efficacy of Sanqi Huazhi Pills in the internal hemorrhoid prolapse: A randomized, double-blind, placebo-controlled l trial

The safety and efficacy of Sanqi Huazhi Pills in the internal hemorrhoid prolapse: A randomized, double-blind, placebo-controlled trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800019420
Enrollment
Unknown
Registered
2018-11-10
Start date
2018-11-10
Completion date
Unknown
Last updated
2018-11-19

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

Conditions

internal hemorrhoid prolapse

Interventions

treatment group:Sanqi Huazhi pills
control group:placebo

Sponsors

The Sixth Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Western medical diagnostic criteria: II-III degree hemorrhoid with prolapse; 2. Differentiation standard of Traditional Chinese Medicine: Fengshang Changluo or Shire Xiazhu; 3. Male or famale aged 18-75 years; 4. voluntary participation.

Exclusion criteria

Exclusion criteria: 1. anal fistula ,rectal polyp, perianal abscess,Anal papilloma,rectal tumor,intestinal infection or with diarrhea; 2. heart disease, myocardial infarction,unstable angina pectoris,chronic cardiac insufficiency(NYHA:III-IV),left ventricular hypertrophy; 3. ALT/AST/Cr>1.5* upper limit of normal; 4. hemoglobin<60g/L; 5. Abnormal coagulation function 6. allergic constitution; 7. dysphrenia; 8. Female in breast nursing or gestation,or to be pregnant; 9. People who have taked decongestnt,anticoagulants,or antibiotics; 10. People who have participated in other clinical trials; 11. People who are excluded by researchers; 12. People who have done surgery.

Design outcomes

Primary

MeasureTime frame
Haemorrhoids prolapse;

Secondary

MeasureTime frame
Anal pain;hematochezia;number of haemorrhoids;haemorrhoid mucosa;haemorrhoids size;external hemorrhoids size;external hemorrhoids swelling;bulge of anus;anus damp;constipation;SF-36 questionnaire scale score;traditional Chinese medicine syndrome differentiation;

Countries

China

Contacts

Public ContactMeijin Huang

The Sixth Affiliated Hospital of Sun Yat-sen University

cysums03@163.com+86 13560031075

Outcome results

None listed

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