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NCT Number: NCT05483595

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangdong Province Hospital of Chinese Medicine

Guangzhou, Guangdong, 510120, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chinese herbal medicine FYTF-919

Drug

Oral liquid 10ml

Other names: Zhong Feng Xing Nao (ZFXN) prescription

Primary outcomes

  1. The percentage of ZFXN response

    Time frame: Within 10 minutes after the first test.

    The incidence of judging testing drug as ZFXN

Secondary outcomes

  1. The artificial sensory score of testing drug

    Time frame: Within 10 minutes after the second test.

    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.

  2. The intelligent sensory attributes of testing drug

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

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

Sponsors and collaborators

Lead sponsor

Guangzhou University of Traditional Chinese Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 2, 2022
Registry last updated
Jan 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.