Condition category
Nervous System Diseases
Date applied
09/11/2018
Date assigned
21/11/2018
Last edited
21/11/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ke Ma

ORCID ID

Contact details

No 1665
Kongjiang Road
Yangpu District
Shanghai
200082
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

XINHUA2018-03

Study information

Scientific title

Clinical study of effects of oral administration of bulleyaconitine A in postherpetic neuralgia

Acronym

Study hypothesis

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

Xinhua Hospital Ethics Committee Affiliated to Shanghai Jiaotong University School of Medicine, 19/09/2018, ref: XHEC-C-2018-011-3

Study design

Multi-center double-blinded randomized controlled clinical study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

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 trial start date

01/06/2018

Overall trial end date

01/04/2020

Reason abandoned (if study stopped)

Eligibility

Participant 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)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant 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

Recruitment start date

01/10/2018

Recruitment end date

01/10/2018

Locations

Countries of recruitment

China

Trial participating centre

Pain Management Department, Xinhua Hospital affiliated to Shanghai Jiaotong University, School of Medicine Shanghai
No 1665 Kongjiang Road, Yangpu District
Shanghai
200082
China

Trial participating centre

Pain Management Department, Qinghai Provincial People's Hospital
No. 2 Gonghe Road, Chengdong District
Xining, Qinghai
810007
China

Trial participating centre

Pain Management Department, Yueyang Hospital affiliated to Shanghai University of Traditional Chinese Medicine
No. 110 Gan he road, Hongkou District
Shanghai
200080
China

Trial participating centre

Pain Management Department, the Second Affiliated Hospital of Kunming Medical University
374 Burma Road
Kunming, Yunnan
650101
China

Sponsor information

Organisation

Xinhua Hospital affiliated with Shanghai Jiaotong University School of Medicine

Sponsor details

No 1665 Kongjiang Road
Yangpu District
Shanghai
200082
China

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Xinhua Hospital (affiliated with Shanghai Jiaotong University School of Medicine)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The paper will be finished and submitted to an appropriate journal in 01/10/2020.

IPD sharing statement
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.

Intention to publish date

01/10/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes