Clinical trial NCT05483595: An Examination of Blinding for Chinese Herbal Oral Liquid and Matched Placebo
Official title: An Examination of Blinding for Chinese Herbal Oral Liquid and Matched Placebo: A Randomized Double-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Placebo Evaluate
Keywords: Traditional Chinese medicine
blinding
physical consistency
evaluation method
Lead sponsor: Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: The percentage of ZFXN response
timeFrame: Within 10 minutes after the first test.
Secondary outcomes:
measure: The artificial sensory score of testing drug
timeFrame: Within 10 minutes after the second test.
measure: The intelligent sensory attributes of testing drug
timeFrame: Immediately after testing by electronic nose an electronic tongue.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Province Hospital of Chinese Medicine
state: Guangdong
Study officials:
affiliation: Study Principal Investigator
name: Craig Anderson, MD
role: PRINCIPAL_INVESTIGATOR
References: