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

Guangzhou University of Traditional Chinese Medicine48 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Placebo Evaluate

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

The percentage of ZFXN response

The incidence of judging testing drug as ZFXN

Time frame: Within 10 minutes after the first test.

Secondary Outcomes

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.

Time frame: Within 10 minutes after the second test.

The intelligent sensory attributes of testing drug

Compare the consistency or difference of artificial sensory (odor, taste) score between two drugs.

Time frame: Immediately after testing by electronic nose an electronic tongue.