Real-World Registry Study on Clinical Analgesic Effect of... | NCT05687929

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

NCT05687929

Sponsor

Ke Ma

Status

Unknown status

Last Update Posted

May 30, 2024Actual

Enrollment

3,500Estimated

Phase

Not provided

Conditions

Chronic Pain

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 27, 2023Actual

Primary Completion Date

Jun 15, 2023Actual

Completion Date

Dec 15, 2024Estimated

First Submitted Date

Dec 27, 2022

First Submission Date that Met QC Criteria

Jan 14, 2023

First Posted Date

Jan 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2024

Last Update Posted Date

May 30, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ke Ma, Principal Investigator, Xinhua Hospital, Shanghai Jiao Tong University School of MedicineSponsor-Investigator

Lead Sponsor

Ke MaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,500Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ma Ke, doctor	Contact	13361879260		marke72@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Third Xiangya Hospital of Central South University	Recruiting	Changsha	Hunan	410000	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D059350	Chronic Pain

Ancestor Terms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided