Placebo EvaluateNCT05483595
An Examination of Blinding for Chinese Herbal Oral Liquid and Matched Placebo
A study testing Chinese herbal medicine FYTF-919 in people with Placebo Evaluate, run by Guangzhou University of Traditional Chinese Medicine at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Placebo Evaluate
- What is being tested?
- Chinese herbal medicine FYTF-919
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 29 Sep 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Age ≥18 years old;
- 2. No visual, olfactory, taste, cognitive impairment;
- 3. Provide written informed consent by patient (or approved surrogate);
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangdong Province Hospital of Chinese Medicine
Guangzhou, Guangdong, 510120
About this study
Official title: An Examination of Blinding for Chinese Herbal Oral Liquid and Matched Placebo: A Randomized Double-blind Clinical Trial
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.
Read the 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
- Being tested
- Chinese herbal medicine FYTF-919
- Keywords
- Traditional Chinese medicine, blinding, physical consistency, evaluation method
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese herbal medicine FYTF-919Drug
Also called Zhong Feng Xing Nao (ZFXN) prescription
Oral liquid 10ml
| Study group | Role | What they receive |
|---|---|---|
| ZFXN group | Other | Subjects actually testing ZFXN Receives: Drug: Chinese herbal medicine FYTF-919 |
| Placebo group | Other | Subjects actually testing placebo Receives: Drug: Chinese herbal medicine FYTF-919 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of ZFXN response
The incidence of judging testing drug as ZFXN
Measured: Within 10 minutes after the first test.
Secondary outcomes (2)
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.
Measured: 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.
Measured: Immediately after testing by electronic nose an electronic tongue.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start29 Sep 2022
- Primary completion1 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Placebo EvaluateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Craig Anderson, MD, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483595
- Sponsor's protocol ID
- BE2022-187
- Status last verified
- Sep 2023
- First submitted
- 31 Jul 2022
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cui W, Xue D, Ouyang W, Zhao Y, Xuan M, Zhou L, Ke G, Gao Y, Kong L, Chen Y, Huang J, Huang H, Lu G, Zeng L, Huang T, Song L, Guo J, Wen Z. Assessing Organoleptic Properties Simulation of a Placebo of Raw Food Material to a Chinese Medicine Oral Liquid FYTF-919. Biomed Res Int. 2026;2026(1):e9000068. doi: 10.1155/bmri/9000068.
PubMed 42669935
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Examination of Blinding for Chinese Herbal Oral Liquid and Matched Placebo: A Randomized Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT05483595
- Acronym / sponsor ID
- BE2022-187
- Conditions
- Placebo Evaluate
- Keywords
- Traditional Chinese medicine, blinding, physical consistency, evaluation method
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Guangzhou University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 29 Sep 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 2 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZFXN group | Other | Drug: Chinese herbal medicine FYTF-919Subjects actually testing ZFXN |
| Placebo group | Other | Drug: Chinese herbal medicine FYTF-919Subjects actually testing placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 1. Age ≥18 years old;
- 2. No visual, olfactory, taste, cognitive impairment;
- 3. Provide written informed consent by patient (or approved surrogate);
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chinese herbal medicine FYTF-919Also: Zhong Feng Xing Nao (ZFXN) prescriptionOral liquid 10ml | Drug | Placebo group, ZFXN group |
Primary outcome
The percentage of ZFXN response
Time frame: Within 10 minutes after the first test.
The incidence of judging testing drug as ZFXN
2 secondary outcomes
The artificial sensory score of testing drug
Time frame: Within 10 minutes after the second test.
The intelligent sensory attributes of testing drug
Time frame: Immediately after testing by electronic nose an electronic tongue.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Derived from this study: PubMed 42669935Cui W, Xue D, Ouyang W, Zhao Y, Xuan M, Zhou L, Ke G, Gao Y, Kong L, Chen Y, Huang J, Huang H, Lu G, Zeng L, Huang T, Song L, Guo J, Wen Z. Assessing Organoleptic Properties Simulation of a Placebo of Raw Food Material to a Chinese Medicine Oral Liquid FYTF-919. Biomed Res Int. 2026;2026(1):e9000068. doi: 10.1155/bmri/9000068.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig Anderson, MD principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chinese herbal medicine FYTF-919 in people with Placebo Evaluate, run by Guangzhou University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of ZFXN response (time frame: Within 10 minutes after the first test.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05483595, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2024.