The clinical research of Pien Tze Huang capsule combine with antivirals in treatment of Herpes zoster

As compare with placebo, a multicenter randomized double-blind parallel design clinical trial, to evaluate the safety and efficacy of Pien Tze Huang capsule combine with antivirals in treatment of Herpes zoster

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1800016441

Enrollment

Unknown

Registered

2018-06-01

Start date

2018-06-01

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Herpes zoster

Interventions

treatment group:PIEN TZE HUANG Capsule + basic treatment

control group:placebo + basic treatment

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years old; 2. Conform to the diagnostic criteria of herpes zoster; 3. Conform to the TCM diagnosed of stagnated heat of liver channel; 4. NRS pain score=4; 5. Palm method for estimation of burn surface area, skin lesions area=2%; 6. Patients with herpes zoster on the skin surface of the trunk (include limbs); 7. Skin lesions occur in 5 days; 8. Patients who sign the informed consent form freely and voluntarily.

Exclusion criteria

Exclusion criteria: 1. Herpes zoster occur in particular site, such as craniofacial herpes zoster, genital herpes zoster, perianal herpes zoster; 2. Skin lesions with pustules, erosion, ulceration, necrosis or serious infection; 3. Those who had used (other than vasiclovir hydrochloride tablets, methylcobalamin tablets, acyclovir cream, and ibuprofen extended-release capsules) medications that are therapeutic for herpes zoster within one week prior to enrollment or those who had used systemic glucocorticosteroids and immunosuppressive agents. 4. Allergic constitution patients, who are allergic to the drugs which used in this research; 5. Patients with peptic ulcer, digestive tract hemorrhage, or asthma patients are allergic to Asprin; 6. Combined with cancer, aids, or other severity serious disease, the liver function (ALT,AST) exceeding 1.5 times than normal limit, the kidney function (Cr) exceeding the normal limit, or those who suffer from impaired immunity disease; 7. Lactating or pregnant women,planning for pregnancy; 8. Participating in other clinical trial, or participated in any other clinical treatment within 3 months prior to screening; 9. The researchers consider the patients are not suitable.

Design outcomes

Primary

Measure	Time frame
NRS pain score on day 7;	—

Secondary

Measure	Time frame
TCM smyptom score;assessment of pain during treatment;use of analgesics;the situation of skin lesions;NK cell (CD3- CD56+);T-lymphocytes (CD3+, CD4+, CD8+, CD4+/CD8+);cytotoxic T cell CD8+CD28+;Regulatory T Cells CD4+CD25+CD127-;IL-6;IL-2;TNF-a;Clinical symptom integral;the incidence of postherpetic neuralgia;	—

Countries

China

Contacts

Public ContactLi Hongyi

Guangdong Provincial Hospital of Chinese Medicine

lihongyich@126.com+86 20 8188 7233

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026