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

NCT05483595 | Completed

• 1 other identifier: BE2022-187
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Placebo Evaluate

Keywords

Traditional Chinese medicine; blinding; physical consistency; evaluation method

Outcome Measures

Primary Outcomes (1)

• The percentage of ZFXN response

  The incidence of judging testing drug as ZFXN

  Within 10 minutes after the first test.

Secondary Outcomes (2)

• The artificial sensory score of testing drug

  Within 10 minutes after the second test.

• The intelligent sensory attributes of testing drug

  Immediately after testing by electronic nose an electronic tongue.

Study Arms (2)

ZFXN group

OTHER

Subjects actually testing ZFXN

Drug: Chinese herbal medicine FYTF-919

Placebo group

OTHER

Subjects actually testing placebo

Drug: Chinese herbal medicine FYTF-919

Interventions

Chinese herbal medicine FYTF-919 DRUG

Oral liquid 10ml

Also known as: Zhong Feng Xing Nao (ZFXN) prescription

Placebo group; ZFXN group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age ≥18 years old;
• \. No visual, olfactory, taste, cognitive impairment;
• \. Provide written informed consent by patient (or approved surrogate);

You may not qualify if:

• \. Evaluation personnel involved in the clinical trial about ZFXN;
• \. Subjects with severe history of heart, liver, kidney, digestive tract, nervous system, respiratory system, mental disorders or metabolic disorders;
• \. Subject with history of food, drug allergies, or other allergic diseases (asthma, urticaria, eczematous dermatitis, etc.) or is known to be allergic toZFXN;
• \. Known definite contraindication to the Chinese herbal medicine;
• \. Women who are known to be pregnant or lactating;
• \. Subjects not fit to participate in this study judged by responsible treating clinician.

Sponsors & Collaborators

• Guangzhou University of Traditional Chinese Medicine: lead

Study Sites (1)

Guangdong Province Hospital of Chinese Medicine

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Interventions

Prescriptions

Intervention Hierarchy (Ancestors)

Pharmaceutical Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Craig Anderson, MD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2022
• First Posted: August 2, 2022
• Study Start: September 29, 2022
• Primary Completion: June 1, 2023
• Study Completion: June 30, 2023
• Last Updated: January 2, 2024

Record last verified: 2023-09

Locations

CN (1)