ITMCTR2200006491尚未招募4 期
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 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional study
入排标准
- 年龄范围
- 18 至 60（—）
- 性别
- All
入选标准
- •(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.
排除标准
- •(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.
研究者
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