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NCT05687929 Clinical Trial

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

Chronic Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05687929
Other study ID # XH-22-008
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 27, 2023
Est. completion date December 15, 2024

Study information
Verified date April 2024
Source Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Contact Ma Ke, doctor
Phone 13361879260
Email marke72@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 3500
Est. completion date December 15, 2024
Est. primary completion date June 15, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
China The Third Xiangya Hospital of Central South University Changsha Hunan

Sponsors (1)
Lead Sponsor Collaborator
Ke Ma

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary VAS (0-100mm), IDpain Pain score December 2022 to December 2023
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