Testing and Evaluation of Placebo Effects for Chinese Herbal Medicine FYTF-919

• Status: Not yet recruiting
• Trial end date: 2023-03-31
• Target enrollment: 0
• Participant gender: All

Summary

TCM is an essential context of the ICH management in Chinese culture. Given the potential benefits of Chinese herbal medicine FYTF-919 in reducing haematoma and bleeding after acute ICH from fundamental research and small clinical studies, more reliable evidence is required to guide ICH treatment using TCM. This study is based on manual scoring and intelligent sensory technology scoring methods, which are used to compare physical consistency between preparation of FYTF-919 and its placebo, simultaneously the two drugs are evaluated in a blinded way. Therefore, the efficacy of placebo preparation of FYTF-919 and feasibility of its application in randomized, double-blind, placebo-controlled clinical trials will be obtained.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Guangzhou University of Traditional Chinese Medicine

Criteria

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 FYTF-919;

• 2. Abnormal vision, smell and taste may exist;

• 3. There may be visual, olfactory and taste disorders;

• 4. Subjects with severe history of heart, liver, kidney, digestive tract, nervous system, respiratory system, mental disorders or metabolic disorders;

• 5. Subject with history of food, drug allergies, or other allergic diseases (asthma, urticaria, eczematous dermatitis, etc.) or is known to be allergic to FYTF-919;

• 6. Known definite contraindication to the Chinese herbal medicine;

• 7. Women who are known to be pregnant or lactating;

• 8. Subjects not fit to participate in this study judged by responsible treating clinician.