None listed
Conditions
Interventions
Drug : Participants will be instructed to take orally 30g of 4 packs per dose three times a day before meals. The daily dose is 90g, and the total duration of treatment is 6 weeks. In the high-dose gr
Sponsors
Dongguk University Bundang Oriental Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age of 19 to 65 years old 2. Presence of persistent pain even after 1 month of PHN standard treatment (Pregabalin, Gabapentin) 3. Average numeric rating scale (NRS) for the past week = 4 4. Average daily pain score (ADPS) for the 1-week screening period = 4 5. Able to voluntarily agree to participate and to sign the informed consent 6. Willingness to participate and sign the informed consent agreement
Exclusion criteria
Exclusion criteria: 1. Head and face affected by HZ 2. The recurrence of HZ or the requirement for treatment 3. Presence of severe nausea, vomiting, gastrointestinal diseases, or history of gastrointestinal surgery that may affect drug absorption 4. Diabetic patient (fasting blood sugar = 128mg/dL or HbA1c = 6.5%); history of diabetes diagnosis or taking diabetes medication 5. Presence or history of myopathy due to hypokalemia 6. Presence of severe uncontrolled hypertension 7. Presence or history of heart disease (coronary artery disease (e.g. cardiomyopathy, myocardial infarction, angina pectoris), congestive heart failure, asymptomatic cardiac dysfunction) 8. Presence of other severe pain, neurological diseases, or red flag sign unrelated to postherpetic neuralgia 9. Presence of malignant cancer within the past five years, severe mental illness, or other systematic diseases 10. Presence of the following abnormalities in laboratory tests: serum potassium < 3.5mmol/L, creatinine clearance < 30mL/min, or HBsAg/HCV Ab (+); abnormal findings in electrocardiogram 11. Presence of hypersensitivity to components of SIKD1977; history of the allergic disease which needs to treat or drug allergy 12. Use of the following drugs for postherpetic neuralgia: NSAIDs, corticosteroid, local anesthetic, opioid analgesics, antidepressants, muscle relaxant, immunosuppressant, potassium/licorice-containing agents, glycyrrhizic acid, thiazide diuretics, loop diuretics (However, participation is possible after washing out for more than 7 days (up to 4 weeks) in accordance with a half-life of each drug) 13. Those who have received or need the following therapy for treating postherpetic neuralgia: nerve block within the past 1 month, radiofrequency ablation, spinal cord stimulator insertion, implantation of a subarachnoidal drug administration system 14. Use of herbal medication within the past 14 days; use of an over-the-counter drug (including vitamin B1 or B12) within the past 10 days 15. Participation in other clinical trials within the past two months 16. Disagreements with the use of the following contraceptive methods during the study period: intrauterine device, barrier contraceptives with spermicide, vasectomy, tubectomy, tubal ligation, or hysterectomy 17. Females who are pregnant or lactating 18. Other disqualifications as determined by the researcher
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The weekly average change in average daily pain score(ADPS) using Numerical rating score (NRS) | — |
Secondary
| Measure | Time frame |
|---|---|
| The weekly average change in average daily pain score(ADPS) using Numerical rating score (NRS);The change of Short Form McGill Pain Questionnaire (SF-MPQ), 100mm Visual analogue scale (VAS);5-level EuroQol-5 dimension (EQ-5D-5L) questionnaire;Patient Global Impression of Change (PGIC) questionnaire;Consumption of rescue drugs (dose, duration, and ratio of patients taken) | — |
Countries
Korea, Republic of
Contacts
Public ContactWonsuk Sung
Dongguk University Bundang Oriental Hospital
Outcome results
None listed