A multicenter, randomized, open, positive drug parallel controlled clinical trial on the efficacy and safety of Pien Tze Huang Capsule combined with Compound Pien Tze Huang Hemorrhoid Ointment after operration of mixed hemorrhoids

Phase 4

• Conditions: After operration of mixed hemorrhoids

• Registration Number: ITMCTR2200006491
• Lead Sponsor: Jiangsu Provincial Hospital of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) Patients with clinical diagnosis of mixed hemorrhoids, who plan to undergo external stripping and internal ligation under spinal anesthesia, and who use electric knife for external hemorrhoids surgery;
(2) Age at the time of informed consent is 18-60 years old (including 18 and 60 years old), and gender is unlimited;
(3) The subjects voluntarily joined the study and signed the written informed consent.

Exclusion Criteria

(1) Annular mixed hemorrhoids;
(2) Combined with anal fissure, hypertrophy of anal papilloma, anal fistula, perianal abscess, anorectal tumor, condyloma acuminatum and other perianal diseases, or congenital anal diseases, or intestinal polyps within 1 month after operation;
(3) Spleen stomach deficiency cold;
(4) People who are known to be allergic to the ingredients contained in the study drug, or patients with allergic constitution;
(5) Pregnant women or lactating women, subjects of childbearing age (including male subjects with heterosexual sexual behavior and their female partners with reproductive potential) have pregnancy plans or are unwilling to take effective contraceptive measures from the screening period to 3 months after drug withdrawal;
(6) Patients with immune deficiency (such as patients with malignant tumors, organ or bone marrow transplants, patients with AIDS, and immune dysfunction caused by long-term use of corticosteroids or other immunosuppressive drugs);
(7) Severe cardiovascular and cerebrovascular diseases, chronic liver (ALT or AST = 2 normal reference upper limit, total bilirubin = 1.5 normal reference upper limit), kidney diseases (serum creatinine > normal reference upper limit and the researcher determines that the abnormality is clinically significant);
(8) Alcoholics and / or psychoactive substances, drug abusers and addicts;
(9) Patients who have participated in clinical trials of other drugs in recent 3 months;
(10) The researcher believes that the subjects with poor compliance or any factors that are not suitable to participate in this Clinical trials.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
?????? Anal margin edema score;VAS score of pain at 6h, 24h, 48h and 72h after operation AUC6-72h;