NCT05687929

Brief Summary

  1. 1.To observe the clinical analgesic effect, safety and adverse reactions of acetylaconitine.
  2. 2.To study and analyze the main influencing factors of the acetylaconitine tablets.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 27, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 18, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

March 27, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
Last Updated

May 30, 2024

Status Verified

April 1, 2024

Enrollment Period

3 months

First QC Date

December 27, 2022

Last Update Submit

May 28, 2024

Conditions

Chronic Pain

Outcome Measures

Primary Outcomes (1)

  • VAS (0-100mm), IDpain

    Pain score

    December 2022 to December 2023

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Ma Ke, doctor

CONTACT

13361879260marke72@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 27, 2022

First Posted

January 18, 2023

Study Start

March 27, 2023

Primary Completion

June 15, 2023

Study Completion

December 15, 2024

Last Updated

May 30, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)