ITMCTR2200006491
Not yet recruiting
Phase 4
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
Jiangsu Provincial Hospital of Chinese Medicine0 sitesTBD
ConditionsAfter operration of mixed hemorrhoids
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- After operration of mixed hemorrhoids
- Sponsor
- Jiangsu Provincial Hospital of Chinese Medicine
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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