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Efficacy and Safety of Interferon-alpha1b (IFN-a1b) Injection into Foramen in Patients with Postherpetic Neuralgia: a Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial

Efficacy and Safety of Interferon-alpha1b (IFN-a1b) Injection into Foramen in Patients with Postherpetic Neuralgia: a Randomized, Double-Blind, Placebo-Controlled, Multicenter Clinical Trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089962
Enrollment
Unknown
Registered
2024-09-20
Start date
2023-04-12
Completion date
Unknown
Last updated
2024-09-23

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

Conditions

Postherpetic Neuralgia

Interventions

Treatment group:IFN-a1b injection into foramen in combination with conventional therapy
Control group:Placebo injection into foramen in combination with conventional therapy

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: All participants in this clinical trial must meet all of the following criteria: 1. Age above 50 years old and below 80 years old, regardless of gender. According to the consensus of Chinese experts on the diagnosis and treatment of postherpetic neuralgia (2016) 2.The disease is defined as a patient diagnosed with PHN, and the course of the disease has lasted for three years since the appearance of the rash Pain for months or more. 3.Postherpetic neuralgia occurs only in the chest, waist, and sacral segments. 4.Those with a VAS score of = 4 and = 8

Exclusion criteria

Exclusion criteria: Participants who meet any of the following criteria shall not be included in this clinical trial: 1. Postherpetic neuralgia in the head, face, and other special areas. 2. Individuals with herpes infection at the puncture site. 3. Coagulation dysfunction. 4. Concomitant severe heart and lung dysfunction; Including those with a history of angina, myocardial infarction, and other serious cardiovascular diseases; 5. Long term use of glucocorticoids or immunosuppressants; 6. Have a history of autoimmune diseases; 7. Concomitant severe liver and kidney dysfunction; Including ALT and AST exceeding the upper limit of normal values by more than 5 times; Or creatinine clearance rate<60 mL · min-1. 8. Individuals with a history of allergies to interferon; 9. Contraindications to interferon include a history of epilepsy or other central nervous system dysfunction; Or those with obvious abnormalities in the hematopoietic system (platelets<30 × 109/L. Neutrophils<0.5 × 109/L); 10. Screening for use of antiviral drugs such as acyclovir and bromofuridine or minimally invasive intervention therapy for PHN within the previous week. 11. Other researchers believe that it is not suitable to enroll in this trial, or the researchers believe that there may be any situation that increases the risk of subjects or interferes with the clinical trial

Design outcomes

Primary

MeasureTime frame
visual analogue scale, VAS;pain relief rate, PRR;

Secondary

MeasureTime frame
short form 12, SF-12;The dosage and duration of calcium ion channel blockers;The proportion of decrease in VZV DNA viral load;Peripheral blood cytokines IL-6, IL-10, and plasma NSE, S100 ß Protein level;

Countries

China

Contacts

Public ContactPeng Mao

China-Japan Friendship Hospital

huhuimin0122@163.com+86 159 0102 0527

Outcome results

None listed

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