Real-World Registry Study on Clinical Analgesic Effect of Acetylaconitine Tablets

May 28, 2024 updated by: Ke Ma
  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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

3500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410000
        • Recruiting
        • The Third Xiangya Hospital of Central South University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic pain > 1 month and VAS > 40 mm Patients who can take the acetylaconitine tablets orally

Description

Inclusion Criteria:

  • Patients with chronic pain > 1 month and VAS > 40 mm Patients who can take the acetylaconitine tablets orally

Exclusion Criteria:

  • Patients who cannot communicate or receive follow-up Patients allergic to acetylaconitine Patients who have taken the acetylaconitine drugs orally

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
VAS (0-100mm), IDpain
Time Frame: December 2022 to December 2023
Pain score
December 2022 to December 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ke Ma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2023

Primary Completion (Actual)

June 15, 2023

Study Completion (Estimated)

December 15, 2024

Study Registration Dates

First Submitted

December 27, 2022

First Submitted That Met QC Criteria

January 14, 2023

First Posted (Actual)

January 18, 2023

Study Record Updates

Last Update Posted (Actual)

May 30, 2024

Last Update Submitted That Met QC Criteria

May 28, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XH-22-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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