Clinical trial NCT06985589: Efficacy and Safety of Fire Needle Therapy Combined With Cortex Phellodendri Compound Fluid Wet Compress for Acute Herpes Zoster: a Randomized Controlled Trial.
Official title: Efficacy and Safety of Fire Needle Therapy Combined With Cortex Phellodendri Compound Fluid Wet Compress for Acute Herpes Zoster: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Herpes Zoster
Keywords: acute Herpes zoster
fire needle therapy
Cortex Phellodendri compound fluid
randomized controlled trial
Lead sponsor: Second Affiliated Hospital of Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2025-05-22
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Herpes zoster (HZ) results from a reactivation of varicella-zoster virus (VZV), which causes primary infection leading to chickenpox and remains latent in the ganglia. Fire needle therapy is a non-pharmacological treatment that combines heat therapy with traditional acupuncture. This technique involves heating sterilized needles and swiftly inserting them into specific points or areas of the skin. Chinese herbal wet compress therapy is directly delivering medications to the lesion site, facilitating rapid transdermal absorption. This method ensures stable local drug concentrations and effectively alleviates pain, swelling, and other clinical symptoms. In this study, we conducted a randomized controlled trial to evaluate the clinical efficacy and safety of fire needle therapy combined with CPCF wet compress for the treatment of acute HZ. 32 acute HZ patients were randomized into control (standard antiviral and analgesic therapy) and treated groups (standard therapy plus fire needle \[5 sessions, every other day\] and CPCF wet compress \[3 times/day, 10 days\]). After 10 days of treatment, fire needle combined with CPCF wet compress significantly enhances symptom relief, pain reduction, and quality of life in acute HZ, with favorable safety.

Detailed description: Herpes zoster (HZ) results from a reactivation of varicella-zoster virus (VZV), which causes primary infection leading to chickenpox and remains latent in the ganglia. Fire needle therapy is a non-pharmacological treatment that combines heat therapy with traditional acupuncture. This technique involves heating sterilized needles and swiftly inserting them into specific points or areas of the skin. Chinese herbal wet compress therapy is directly delivering medications to the lesion site, facilitating rapid transdermal absorption. This method ensures stable local drug concentrations and effectively alleviates pain, swelling, and other clinical symptoms. In this study, we conducted a randomized controlled trial to evaluate the clinical efficacy and safety of fire needle therapy combined with CPCF wet compress for the treatment of acute HZ. 32 acute HZ patients were randomized into control (standard antiviral and analgesic therapy) and treated groups (standard therapy plus fire needle \[5 sessions, every other day\] and CPCF wet compress \[3 times/day, 10 days\]). After 10 days of treatment, fire needle combined with CPCF wet compress significantly enhances symptom relief, pain reduction, and quality of life in acute HZ, with favorable safety.

Eligibility criteria: Inclusion Criteria:

1. males and females, aged 18-80 years old;
2. diagnosed as acute HZ with the course of disease within 7 days;
3. without history of other treatment before enrollment.

Exclusion Criteria:

1. specific types of HZ, including Ramsay Hunt Syndrom, ophthalmic, disseminated, deep, purpuric and central nervous system HZ;
2. pregnancy and lactation;
3. allergic to the related Chinese herbals;
4. patients with contraindications to penciclovir, mecobalamin and pregabalin; (e) history of hypertrophic scar or keloid;

(f) severe cardiovascular, cerebrovascular, digestive, urinary or hematopoietic disease; (g) mental disease; (h) coagulation disorders.

Primary outcomes:
measure: herpes zoster symptom and sign quantitative scoring scale
timeFrame: From enrollment to day 10
measure: lesion improvement index n
timeFrame: From enrollment to day 10
measure: the total improved rate
timeFrame: From enrollment to day 10
Secondary outcomes:
measure: questionnaire of Dermatology Life Quality Index
timeFrame: From enrollment to day 10
measure: Pittsburgh sleep quality index
timeFrame: From enrollment to day 10
measure: Hamilton Anxiety Scale
timeFrame: From enrollment to day 10
measure: Visual analog scale
timeFrame: From enrollment to day 10
measure: incidence of postherpetic neuralgia
timeFrame: From enrollment to day 90
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: Second Affiliated Hospital of Xi'an Jiaotong University
name: Weihui Zeng
role: STUDY_CHAIR
References:
citation: Zeng JC, Liao YZ, Li JJ, Lu LH, Li HZ, Lu LM, Li QJ, Li LX, Wang SX, Lin GH. [Clinical efficacy of fire needling combined with cupping therapy on herpes zoster of acute stage and the effect on Th17/Treg cellular immune balance]. Zhongguo Zhen Jiu. 2023 Oct 12;43(10):1128-33. doi: 10.13703/j.0255-2930.20221005-k0004. Chinese.
citation: Zhang Y, Li SH, Yang L, Xu QN, Pei WY, Liang ZH, Liu XH, Yang JJ, Lin GH. [Shallow Fire-needle Acupuncture Stimulation Plus Cupping Relieves Neuralgia and Down-regulates Serum Substance P Level in Patients with Acute Herpes Zoster]. Zhen Ci Yan Jiu. 2018 Aug 25;43(8):492-4. doi: 10.13702/j.1000-0607.170923. Chinese.
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citation: Chen J, Luo C, Ju P, Tu S, Shi S, Wang Z, Wu H. A bibliometric analysis and visualization of acupuncture and moxibustion therapy for herpes zoster and postherpetic neuralgia. Skin Res Technol. 2024 Jun;30(6):e13815. doi: 10.1111/srt.13815.
citation: Dai YX, Yeh FY, Shen YJ, Tai YH, Huang N, Chang YT, Chen TJ, Li CP, Wu CY. Cigarette smoking and risk of herpes zoster: a population-based cohort study in Taiwan. Clin Exp Dermatol. 2021 Oct;46(7):1293-1298. doi: 10.1111/ced.14650. Epub 2021 May 11.
citation: Patil A, Goldust M, Wollina U. Herpes zoster: A Review of Clinical Manifestations and Management. Viruses. 2022 Jan 19;14(2):192. doi: 10.3390/v14020192.