An Examination of Blinding for Chinese Herbal Oral Liquid and Matched Placebo: A Randomized Double-blind Clinical Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Examination of Blinding for Chinese Herbal Oral Liquid and Matched Placebo: A Randomized Double-blind Clinical Trial

Conditions
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Placebo Evaluate

Intervention / Treatment
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* Drug: Chinese herbal medicine FYTF-919


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ZFXN group<br>Subjects actually testing ZFXN | Drug: Chinese herbal medicine FYTF-919<br>* Oral liquid 10ml<br>* Other names: Zhong Feng Xing Nao (ZFXN) prescription;|
| Other: Placebo group<br>Subjects actually testing placebo | Drug: Chinese herbal medicine FYTF-919<br>* Oral liquid 10ml<br>* Other names: Zhong Feng Xing Nao (ZFXN) prescription;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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 | Compare the consistency or difference of artificial sensory (odor, taste) score between two drugs. | Immediately after testing by electronic nose an electronic tongue. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Traditional Chinese medicine, blinding, physical consistency, evaluation method