The effects of oral administration of bulleyaconitine A in postherpetic neuralgia

Not Applicable

Completed

• Conditions: euralgia; Nervous System Diseases

• Registration Number: ISRCTN16975505
• Lead Sponsor: Xinhua Hospital affiliated with Shanghai Jiaotong University School of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-21
• Last Update Posted: 10 December 2018
• Study Completion: 2020-04-01

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 120

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 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.<br> 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<br> 3. The dosage of Gabapentin per day during the treatment<br>

Secondary Outcome Measures

Name	Time	Method
<br> 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<br> 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<br> 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<br>