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Clinical Observations on the Herpes Simplex Type 2 Formula in Reducing the Recurrence Rate of Genital Herpes and Its Impact on Immunological Mechanisms

Clinical Observations on the Herpes Simplex Type 2 Formula in Reducing the Recurrence Rate of Genital Herpes and Its Impact on Immunological Mechanisms

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000128
Enrollment
Unknown
Registered
2026-01-24
Start date
2025-04-06
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Genital Herpes

Interventions

Control Group:Valacyclovir Hydrochloride Capsules 250 mg, twice daily, two capsules each time, taken orally before meals.
Treatment group:Herpes Formula No. 2, twice daily, 250ml per dose, oral administration after meals. Concurrently, take Valacyclovir Hydrochloride Capsules 250mg twice daily, 2 capsules each time, oral

Sponsors

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 49 Years

Inclusion criteria

Inclusion criteria: (1) Patients aged between 18 and 49 years old, who meet the diagnostic criteria for genital herpes in Western medicine and the symptom criteria for related conditions in Traditional Chinese Medicine (TCM); (2) Patients with recurrence frequency exceeding 6 times in the past year; (3) Patients willing to participate in the study and sign the informed consent form. Western Medical Diagnostic Criteria Reference: "Consensus on the Integrated Traditional Chinese and Western Medicine Diagnosis and Treatment of Genital Herpes 2020" by the Chinese Society of Integrated Traditional and Western Medicine for Dermatology and Venereology. Confirmed cases of genital herpes must meet the following criteria: (1) Epidemiological history: History of unsafe sexual behavior, multiple sexual partners, or sexual partners with infections; (2) Clinical manifestations: Vesicles, ulcers, erosion, etc.; (3) Laboratory tests: Including nucleic acid testing, virus culture, antigen detection, and antibody detection. Confirmed diagnosis: Must meet both epidemiological history and clinical manifestations, and have a positive result in any one of the following tests: virus culture, antigen detection, or nucleic acid testing. TCM Symptom Criteria Reference: "TCM Surgery," Chapter 6, Section 1, diagnostic criteria. TCM diagnosis: Heat sores (re). Primary symptoms: Predominantly characterized by the yin deficiency with internal heat syndrome. Manifested as recurrent episodes of yin deficiency with internal heat (with more than 6 recurrences in the past year), accompanied by dry mouth and lips, slight fever in the afternoon, red tongue, thin coating, and fine rapid pulse.

Exclusion criteria

Exclusion criteria: 1) Patients with primary outbreaks of herpes simplex virus (HSV); 2) Patients who do not meet the above inclusion criteria; 3) Pregnant women and breastfeeding women; 4) Patients allergic to the drugs used in this study; 5) Patients with severe allergic constitutions; 6) Patients with severe cardiovascular diseases, hepatic or renal insufficiency, hematological disorders, autoimmune diseases, or mental disorders; 7) Patients who refuse to cooperate with treatment or follow-up.

Design outcomes

Primary

MeasureTime frame
Herpes recurrence frequency;

Secondary

MeasureTime frame
Relapse Symptom Assessment;Immunological Serological Testing;TCM Syndrome Score;

Countries

China

Contacts

Public ContactXiang He

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

heroxiang@hotmail.com13681737694

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 7, 2026