The effects of oral administration of bulleyaconitine A in postherpetic neuralgia
| ISRCTN | ISRCTN16975505 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16975505 |
| Secondary identifying numbers | XINHUA2018-03 |
- Submission date
- 09/11/2018
- Registration date
- 21/11/2018
- Last edited
- 21/11/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims
Postherpetic neuralgia is lasting neuropathic pain in an area previously affected by shingles. It seriously affects the patient's sleep, mood and quality of life. After treatment there are still some patients who suffer from neuropathic pain and it is still a difficult clinical problem. Bulleyaconitine A is an analgesic drug isolated from Aconitum plants. It was found that bulleyaconitine A could block pain-related sodium channels, producing strong analgesic and anti-inflammatory effects. The aim of this study is to assess the effects of bulleyaconitine A on postherpetic neuralgia, anxiety, depression and quality of life, and its safety and side effects.
Who can participate?
Patients aged 18 to 80 with postherpetic neuralgia
What does the study involve?
Participants are randomly allocated to two groups. Those in group 1 are given bulleyaconitine A to take orally three times a day for 28 days. Those in group 2 are given a pIacebo (dummy drug). The basic treatment is oral Gabapentin three times a day. The pain experienced after treatment is assessed for each patient every day for the next 3 months.
What are the possible benefits and risks of participating?
The possible benefit is that the participants could get pain relief and bulleyaconitine A for free. The possible risks are side effects of bulleyaconitine A such as dizziness and palpitation.
Where is the study run from?
1. Pain Management Department, Xinhua Hospital affiliated to Shanghai Jiaotong University, School of Medicine Shanghai (China)
2. Pain Management Department, Qinghai Provincial People's Hospital (China)
3. Pain Management Department, Yueyang Hospital affiliated to Shanghai University of Traditional Chinese Medicine (China)
4. Pain Management Department, the Second Affiliated Hospital of Kunming Medical University (China)
When is the study starting and how long is it expected to run for?
June 2018 to April 2020
Who is funding the study?
Xinhua Hospital (affiliated with Shanghai Jiaotong University School of Medicine) (China)
Who is the main contact?
Prof. Ke Ma
Contact information
Scientific
No 1665
Kongjiang Road
Yangpu District
Shanghai
200082
China
Study information
| Study design | Multi-center double-blinded randomized controlled clinical study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Clinical study of effects of oral administration of bulleyaconitine A in postherpetic neuralgia |
| Study objectives | 1. Oral administration of bulleyaconitine A is effective and safe when administered for postherpetic neuralgia patients. 2. Treatment of oral administration of bulleyaconitine A can improve the quality of life of postherpetic neuralgia patients. |
| Ethics approval(s) | Xinhua Hospital Ethics Committee Affiliated to Shanghai Jiaotong University School of Medicine, 19/09/2018, ref: XHEC-C-2018-011-3 |
| Health condition(s) or problem(s) studied | Neuralgia |
| Intervention | 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 group 2 (n=60) are given pIacebo. The basic treatment is oral administration of Gabapentin 0.3 g t.i.d. The pain experienced after treatment is assessed for each patient every day for the next 3 months. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Bulleyaconitine A |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 01/06/2018 |
| Completion date | 01/04/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 120 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 01/10/2018 |
| Date of final enrolment | 01/10/2018 |
Locations
Countries of recruitment
- China
Study participating centres
Shanghai
200082
China
Xining, Qinghai
810007
China
Shanghai
200080
China
Kunming, Yunnan
650101
China
Sponsor information
Hospital/treatment centre
No 1665 Kongjiang Road
Yangpu District
Shanghai
200082
China
"ROR" |
https://ror.org/04dzvks42 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/10/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | The paper will be finished and submitted to an appropriate journal in 01/10/2020. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
