Chronic PainNCT05687929
Real-World Registry Study on Clinical Analgesic Effect of Acetylaconitine Tablets
An observational study of Chronic Pain, run by Ke Ma at 1 site in China.
Trial summary
1. To observe the clinical analgesic effect, safety and adverse reactions of acetylaconitine. 2. To study and analyze the main influencing factors of the acetylaconitine tablets. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Pain
- How many people
- 3,500 participants
- Where
- 1 siteChina
- Study dates
- 27 Mar 2023to 15 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with chronic pain > 1 month and VAS > 40 mm Patients who can take the acetylaconitine tablets orally
Who may be able to join
- Patients with chronic pain > 1 month and VAS > 40 mm Patients who can take the acetylaconitine tablets orally
Who cannot join
- Patients who cannot communicate or receive follow-up Patients allergic to acetylaconitine Patients who have taken the acetylaconitine drugs orally
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410000
Huang Dong, 13787412741, huangdong6619@vip.163.com
About this study
- To observe the clinical analgesic effect, safety and adverse reactions of acetylaconitine.
- To study and analyze the main influencing factors of the acetylaconitine tablets.
Read the detailed description
The outpatients/inpatients meeting the criteria are included into this study after signing the Informed Consent Form. The patients received 5 visits in total, which take place after the patients are included into the real-world study, on the 3rd day after enrollment and at the 1st, 4th, 8th and 12th weeks thereafter, in the form of outpatient follow-up, telephone follow-up and APP follow-up.
- Conditions
- Chronic Pain
- Medical subject headings
- Chronic Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS (0-100mm), IDpain
Pain score
Measured: December 2022 to December 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start27 Mar 2023
- Primary completion15 Jun 2023
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ke Ma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ke Ma, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05687929
- Sponsor's protocol ID
- XH-22-008
- Status last verified
- Apr 2024
- First submitted
- 27 Dec 2022
- Last updated
- 30 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Registry Study on Clinical Analgesic Effect of Acetylaconitine Tablets
- ClinicalTrials.gov ID
- NCT05687929
- Acronym / sponsor ID
- XH-22-008
- Conditions
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,500 participants (estimated)
- Lead sponsor
- Ke MaUniversity, hospital or other
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 18 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To observe the clinical analgesic effect, safety and adverse reactions of acetylaconitine.
- To study and analyze the main influencing factors of the acetylaconitine tablets.
Detailed description
The outpatients/inpatients meeting the criteria are included into this study after signing the Informed Consent Form. The patients received 5 visits in total, which take place after the patients are included into the real-world study, on the 3rd day after enrollment and at the 1st, 4th, 8th and 12th weeks thereafter, in the form of outpatient follow-up, telephone follow-up and APP follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with chronic pain > 1 month and VAS > 40 mm Patients who can take the acetylaconitine tablets orally
Key inclusion criteria (1 listed)
- Patients with chronic pain > 1 month and VAS > 40 mm Patients who can take the acetylaconitine tablets orally
Key exclusion criteria (1 listed)
- Patients who cannot communicate or receive follow-up Patients allergic to acetylaconitine Patients who have taken the acetylaconitine drugs orally
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
VAS (0-100mm), IDpain
Time frame: December 2022 to December 2023
Pain score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Ke Ma at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ma Ke, doctor (13361879260, marke72@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (0-100mm), IDpain (time frame: December 2022 to December 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.