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

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.

Study Overview

• Status: Completed
• Conditions: Placebo Evaluate
• Intervention / Treatment: Drug: Chinese herbal medicine FYTF-919

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jianwen Guo, MD; Phone Number: +86-13724899379; Email: jianwen_guo@qq.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Guangdong Province Hospital of Chinese Medicine
      • Contact: Jianwen Guo, MD; Phone Number: +86 13724899379; Email: jianwen_guo@qq.com
      • Contact: Lily Song, PhD; Phone Number: +86 13916466400; Email: lsong@georgeinstitute.org.cn
      • Principal Investigator: Craig Anderson, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety outcome indicators	Serious adverse event (SAE) and adverse event of special interest (AESI) during follow-up for all randomized subjects	during and 30 minutes after the follow-up

Collaborators and Investigators

• Sponsor: Guangzhou University of Traditional Chinese Medicine
• Investigators: Principal Investigator: Craig Anderson, MD, Study Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2022
• Primary Completion (Actual): June 1, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: July 31, 2022
• First Submitted That Met QC Criteria: July 31, 2022
• First Posted (Actual): August 2, 2022

Study Record Updates

• Last Update Posted (Estimated): January 1, 2024
• Last Update Submitted That Met QC Criteria: December 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Traditional Chinese medicine; blinding; physical consistency; evaluation method
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Cerebral Hemorrhage
• Other Study ID Numbers: BE2022-187

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No