Neuralgia Nervous System Diseases
Conditions
Interventions
120 participants are randomly allocated to two groups using a random number table for randomization. Those in group 1 (n=60) are given bulleyaconitine A 0.4 mg t.i.d. orally for 28 days. Those in grou
Sponsors
Xinhua Hospital affiliated with Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects voluntarily signed the informed consent 2. Patients suffering from postherpetic neuralgia aged from 18 to 80 regardless of gender 3. Moderate to severe pain, VAS> 4 points or more, or burst pain> 3 times/day 4. Patients can follow the drug dose and follow-up plan 5. Patients can describe the symptoms, no serious infection, respiratory insufficiency and has the ability to cooperate 6. Non-allergic persons 7. No drug abuse or drug addiction 8. Non-lactating, non-pregnant women, subjects who did not have a pregnancy plan within 1 month after the test 9. Patients did not participate in a drug test within 3 months before this test (including the test drug)
Exclusion criteria
Exclusion criteria: 1. Researchers think that there is any reason participant should be excluded 2. In poor situation, severe systemic infection or respiratory dysfunction and uncooperative 3. Suffering from severe respiratory system, cardiovascular system diseases, liver and kidney dysfunction, cancer 4. Patients who are allergic to bulleyaconitine A 5. Patient who has or a history of drug abuse 6. Breastfeeding, gestational women or subjects who do not have a pregnancy plan within 1 month after the test 7. Patients who participated in a drug trial within 3 months before this trial 8. Patients does not meet the inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Pain, measured using the visual analogue score (VAS) during the treatment and at 7 days, 14 days, 21 days, 28 days, 2 months and 3 months post-treatment. 2. The frequency and intensity of the pain outbreak measured using the visual analogue score (VAS) during the treatment and at 7 days, 14 days, 21 days, 28 days, 2 months and 3 months post-treatment 3. The dosage of Gabapentin per day during the treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Intensity of anxiety, measured using the PHQ-9 evaluation scale during the treatment and at 7 days, 14 days, 21 days, 28 days, 2 months and 3 months after treatment 2. Intensity of depression, measured by the GAD-7 anxiety screening scale during the treatment and at 7 days, 14 days, 21 days, 28 days, 2 months and 3 months after treatment 3. Quality of life, measured by the quality of life score (QOL) during the treatment and at 7 days, 14 days, 21 days, 28 days, 2 months and 3 months after treatment | — |
Countries
China
Outcome results
None listed