The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110001, China
Location status: Recruiting
NCT Number: NCT06827938
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.
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Interventional
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Shenyang, Liaoning, 110001, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Three months
Three months after treatment, the overall cure rate of skin lesions is assessed.
Time frame: Six months
Six months after treatment, the overall cure rate of skin lesions is assessed.
Time frame: Three months
Three months after treatment, the recurrence rate of skin lesions is assessed.
Time frame: Six months
Six months after treatment, the recurrence rate of skin lesions ie assessed.
Time frame: Three months
During treatment, adverse reactions and the incidence of treatment-related adverse reactions were recorded.
Time frame: Six months
During treatment, adverse reactions and the incidence of treatment-related adverse reactions were recorded.
Contact information is provided by the study sponsor or research team.
First Hospital of China Medical University
Other
Multicenter Real-World Study of Hyperthermia in Skin/Mucosal HPV Infection of Special Population
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