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Completed

NCT Number: NCT06985589

Efficacy and Safety of Fire Needle Therapy Combined With Cortex Phellodendri Compound Fluid Wet Compress for Acute Herpes Zoster: a Randomized Controlled Trial.

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.

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Key information

Conditions

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • specific types of HZ, including Ramsay Hunt Syndrom, ophthalmic, disseminated, deep, purpuric and central nervous system HZ;
  • pregnancy and lactation;
  • allergic to the related Chinese herbals;
  • 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.

Treatment and study plan

Fire needle

Procedure

At the beginning of the fire needle therapy, the patient was instructed to exposure the lesion in a comfortable position. And the Ashi point (lesion area) was disinfected with iodophor. The 95% alcohol lamp was lit and held by the left hand. Then the needle was held by the right hand in the outer flame of the alcohol lamp to heat the needle body, making the tip of the needle whiten. Subsequently, the needle was quickly and accurately puncted into the base of the herpes at a depth of about 2-5 mm, straight in and out. According to the number of herpes, the early-onset herpes was puncted first, and about 5 to 10 blisters were selected for each puncture. The acupuncture was performed 1-5 times according to the size of the herpes. The treatment was performed once every other day for total 5 sessions.

Cortex Phellodendri compound fluid wet compress

Drug

For the Chinese herbal wet compress treatment, CPCF (Shandong Hanfang Pharmaceutical Co., LTD.) was decocted using forsythia, honeysuckle, phellodendron, dandelion, and centipede. Appropriate amount of liquid was diluted with 5 times the volume of water. Then according to the area of skin lesions, several pieces of medical fat-free cotton gauze with thickness of 8 layers were put into the liquid completely wet. After wringing out to a semi-dry state, the gauze was applied to the lesion for 15 minutes/time, 3 times a day, for 10 days.

Basic treatment

Drug

The basic treatment consisted of penciclovir 0.5g/time per day intravenously, mecobalamin 0.5mg/time three times a day orally and pregabalin 75mg/time twice a day orally for 10 days.

Primary outcomes

  1. herpes zoster symptom and sign quantitative scoring scale

    Time frame: From enrollment to day 10

    The degree of the clinical symptoms and signs of HZ (including local pain, local itching, burning sensation, papular erythema, number of blisters, number of blister clusters, herpes character, ulcer, fever, local lymph node enlargement, and skin lesion area change) were divided into four grades: 0 (none), 1 (mild), 2 (moderate), and 3 (severe).

  2. lesion improvement index n

    Time frame: From enrollment to day 10

    The lesion improvement index n was calculated by the formula: n (%) = (symptom and sign quantitative score at baseline - symptom and sign quantitative score at 10 days)/symptom and sign quantitative score at baselin ×100%.

  3. the total improved rate

    Time frame: From enrollment to day 10

    The clinical improvement was graded as follows: clinical cure (n≥90%), significant improvement (70%≤n<90%), moderate improvement (30%≤n<70%), no improvement (n < 30%). The total improved rate was calculated as cases of (clinical cure + significant improvement + moderate improvement)/total cases×100%.

Secondary outcomes

  1. questionnaire of Dermatology Life Quality Index

    Time frame: From enrollment to day 10

  2. Pittsburgh sleep quality index

    Time frame: From enrollment to day 10

  3. Hamilton Anxiety Scale

    Time frame: From enrollment to day 10

  4. Visual analog scale

    Time frame: From enrollment to day 10

    The pain intensity due to HZ was evaluated by a visual analog scale (VAS) ranging from 0 to 10 (0: no pain, 1-3: mild, 4-6: moderate, 7-10: severe) at day 0 and day 10.

  5. incidence of postherpetic neuralgia

    Time frame: From enrollment to day 90

    The incidence of postherpetic neuralgia was analysed at day 90.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Xi'an Jiaotong University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
May 22, 2025
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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