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临床试验/NCT06827938
NCT06827938招募中不适用

Multicenter Real-World Study of Hyperthermia in Skin/Mucosal HPV Infection of Special Population

First Hospital of China Medical University1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2024年7月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
400
试验地点
1
主要终点
The recurrence rate

研究概览

简要总结

Hyperthermia refers to treating diseases with temperatures beyond normal body temperature (39-45℃), and moxibustion therapy of traditional Chinese medicine belongs to the category of hyperthermia. It has been reported at home and abroad that the local temperature of 44℃ can effectively mobilize the body's immunity and remove HPV infection lesions, such as condyloma acuminatum and verruca vulgaris. Our research group conducted randomized controlled experiments on patients with viral warts in the early clinical practice, and the cure rate of the hyperthermia group reached 45-55%, which was superior to the traditional method in the aspects of no trauma, low recurrence rate, easy to tolerate and so on. Our research group's preliminary research on hyperthermia of viral warts has been included in the British Medical Association's guidelines for viral warts therapy. The equipment our research group developed has been obtained the medical device registration certificate, and is in the process of national promotion. Hyperthermia is to mobilize systemic immunity through local warm heat, the preliminary clinical study of the research group shows that the therapeutic effect of hyperthermia is usually "all or none": "all" that is, after hyperthermia, all viral warts are removed, including non-treatment lesions;"None" means that some patients with viral warts do not respond to hyperthermia. Cellular immunity plays a very important role in the removal of warts. At present, some special clinical patients such as pregnant women, children, patients with autoimmune diseases, diabetes, immunosuppressants after organ transplantation and other patients with skin/mucosal HPV infection, their warts show more extensive proliferation or a longer and repeated course of disease, treatment resistance, etc. It has increased the difficulty of clinical treatment, and the specific mechanism is still unclear. Therefore, for these special populations, how to further enhance the therapeutic effect of hyperthermia is the top priority of current research.

In view of the above findings, this research group intends to study the efficacy and safety of hyperthermia in the treatment of viral warts in the special population (pregnant women, children, patients with autoimmune diseases, diabetes, and immunosuppressants after organ transplantation, etc.) in a multicenter real-world study of skin/mucosal HPV infection in the special population.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Pregnant women with viral warts
  • •Diagnosis of AIDS with viral warts
  • •Autoimmune disease patients with viral warts
  • •Diabetic patients with viral warts
  • •Patients with viral warts who are currently being treated with immunosuppressants
  • •Children with viral warts
  • •The subject or legal guardian is able to understand and sign the informed consent/consent to participate in the study

排除标准

  • •The subject suffers from tumor or other serious disease and cannot complete this clinical study
  • •Timely treatment and follow-up cannot be guaranteed due to personal or other objective reasons

研究组 & 干预措施

Hyperthermia group

Other

Infrared hyperthermia(44±1℃) device for 3 consecutive days (times / day), each treatment for 30 minutes After 7-10 days, the lesions of the same target were treated continuously for 2 days (times / day), and then treat every 7-10 days, the method was the same as before. Lesion changes were assessed after 15 treatments.

干预措施: YY-WRY-V01 Infrared thermotherapy apparatus (Device)

结局指标

主要结局

The recurrence rate

时间窗: Six months

Six months after treatment, the recurrence rate of skin lesions ie assessed.

The cure rate

时间窗: Six months

Six months after treatment, the overall cure rate of skin lesions is assessed.

The cure rate

时间窗: Three months

Three months after treatment, the overall cure rate of skin lesions is assessed.

The recurrence rate

时间窗: Three months

Three months after treatment, the recurrence rate of skin lesions is assessed.

次要结局

  • The rate of adverse reaction(Six months)
  • The rate of adverse reaction(Three months)

研究者

发起方
First Hospital of China Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gao Xinghua

Professor

First Hospital of China Medical University

研究点 (1)

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