An Examination of Blinding for Chinese Herbal Oral Liquid... | NCT05483595

Studies
An Examination of Blinding for Chinese Herbal Oral Liquid and Matched Placebo

NCT05483595

Sponsor

Guangzhou University of Traditional Chinese Medicine

Status

Completed

Last Update Posted

Jan 2, 2024Actual

Enrollment

48Actual

Phase

Not Applicable

Conditions

Placebo Evaluate

Interventions

Chinese herbal medicine FYTF-919

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

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 29, 2022Actual

Primary Completion Date

Jun 1, 2023Actual

Completion Date

Jun 30, 2023Actual

First Submitted Date

Jul 31, 2022

First Submission Date that Met QC Criteria

Jul 31, 2022

First Posted Date

Aug 2, 2022Actual

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

Dec 26, 2023

Last Update Posted Date

Jan 2, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

TCM is an essential context of the ICH management in Chinese culture. Given the potential benefits of Chinese herbal medicine Zhongfengxingnao formula (ZFXN) in reducing haematoma and bleeding after acute intracerebral hemorrhage (ICH) from fundamental research and small clinical studies, more reliable evidence is required to guide ICH treatment using TCM. This study is designed to evaluate the blinding and physical consistency between the investigational drug and placebo in RCT, taking the trial named Chinese herbal medicine in patients with acute intracerebral hemorrhage (CHAIN) as an example. Therefore the blinding of placebo as well as and physical consistency with investigated TCM in CHAIN trial will be determined. In addition, an assessment method for blinding and physical consistency could be developed for subsequent placebo evaluations.

Detailed Description

A total of 48 subjects will be divided into two parts for manual scoring, which includes not only the proportion of the discrimination to ZFXN, which is the primary outcome in this study, but also the physical (odor, taste) consistency of the two drugs. The primary outcome was the percentage of ZFXN response. The secondary outcomes included artificial sensory score and intelligent sensory attributes of testing drug.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ZFXN group	Other	Subjects actually testing ZFXN	Drug: Chinese herbal medicine FYTF-919
Placebo group	Other	Subjects actually testing placebo	Drug: Chinese herbal medicine FYTF-919

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Chinese herbal medicine FYTF-919	Drug	Oral liquid 10ml	Placebo group ZFXN group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The percentage of ZFXN response	The incidence of judging testing drug as ZFXN	Within 10 minutes after the first test.

Secondary Outcomes

Measure	Description	Time Frame
The artificial sensory score of testing drug	Compare the consistency or difference of artificial sensory (odor, taste) score between two drugs. The value range from 0 to 10: higher scores mean a better consistency.	Within 10 minutes after the second test.
The intelligent sensory attributes of testing drug

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1. Age ≥18 years old;
2. No visual, olfactory, taste, cognitive impairment;
3. Provide written informed consent by patient (or approved surrogate);

Exclusion Criteria:

1. Evaluation personnel involved in the clinical trial about ZFXN;
2. Subjects with severe history of heart, liver, kidney, digestive tract, nervous system, respiratory system, mental disorders or metabolic disorders;
3. Subject with history of food, drug allergies, or other allergic diseases (asthma, urticaria, eczematous dermatitis, etc.) or is known to be allergic toZFXN;
4. Known definite contraindication to the Chinese herbal medicine;
5. Women who are known to be pregnant or lactating;
6. Subjects not fit to participate in this study judged by responsible treating clinician.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Craig Anderson, MD	Study Principal Investigator	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Guangdong Province Hospital of Chinese Medicine		Guangzhou	Guangdong	510120	China

Intervention Browse Module

MeSH Terms

ID	Term
D055656	Prescriptions

Ancestor Terms

ID	Term
D010593	Pharmaceutical Services
D006296	Health Services
D005159	Health Care Facilities Workforce and Services

Browse Leaves

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Browse Branches

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