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

NCT ID: NCT05483595

Last Updated: 2024-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-29
• Study Completion Date: 2023-06-30

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.

Conditions

Placebo Evaluate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

ZFXN group

Subjects actually testing ZFXN

Group Type: OTHER

Chinese herbal medicine FYTF-919

Intervention Type: DRUG

Oral liquid 10ml

Placebo group

Subjects actually testing placebo

Group Type: OTHER

Chinese herbal medicine FYTF-919

Intervention Type: DRUG

Oral liquid 10ml

Interventions

Chinese herbal medicine FYTF-919

Oral liquid 10ml

Intervention Type: DRUG

Other Intervention Names

Zhong Feng Xing Nao (ZFXN) prescription

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Guangzhou University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Craig Anderson, MD

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

Guangdong Province Hospital of Chinese Medicine

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

BE2022-187

Identifier Type: -

Identifier Source: org_study_id