Health volunteers
Conditions
Interventions
Polygoni Multiflori Radix Praeparata Formula Granules:Polygoni Multiflori Radix Praeparata Formula Granules
Placebo Control Group:Equal Volume of Warm Water
Polygoni Multiflori Radix Praeparata:Polygoni Multiflori Radix Praeparata
Sponsors
Southern Medical University Southern Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1.Age at the time of signing the informed consent form must be between 18 and 55 years (inclusive), male or female; 2.The subject has no history of severe digestive system disorders (e.g., inflammatory bowel disease, chronic diarrhea, Crohn’s disease, autonomic neuropathy affecting gastric emptying), central nervous system, cardiovascular system, renal, respiratory system, metabolic and endocrine, musculoskeletal system, hematologic diseases, or malignancy; 3.The subject (including their partner) must agree to complete abstinence or the use of effective physical contraception (including sterilization, intrauterine device, or barrier methods) from the time of signing the informed consent until 3 months after the last dose. If a female subject is using hormonal contraceptives, they must discontinue use >14 days before the first dose and adopt at least one of the aforementioned contraceptive measures; 4.Male subjects must weigh >=50 kg, and female subjects must weigh =45 kg, with a body mass index (BMI) between 18–28 kg/m² (inclusive), where BMI = weight (kg)/height² (m²); 5.Capable of understanding and complying with the study procedures; 6.Willing to participate in the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Clinically significant abnormalities in vital signs, physical examination, or laboratory tests; 2.Abnormal electrocardiogram (ECG) or echocardiography results, including but not limited to: QTcF >= 450 ms (corrected using Fridericia’s formula: QTcF = QT/[RR^0.33], where RR = 60/heart rate); Any ECG abnormality deemed clinically significant by the investigator; Left ventricular ejection fraction (LVEF) 5 cigarettes/day within 3 months prior to screening), excessive alcohol consumption (>14 drinks/week, where 1 drink = 360 mL beer, 150 mL wine, or 50 mL spirits), or drug abuse/substance use disorder; 11.Positive results in smoking screening, alcohol breath test, or drug abuse screening; 12.Known history of any drug or food allergies requiring medication or presence of allergic diseases; 13.Blood donation or blood loss >= 450 mL within 3 months prior to study drug administration, or planned blood donation during the study; 14.Undergone major surgery (>= Grade 2) within 6 months prior to study drug administration or anticipated need for surgery/hospitalization during the study; 15.Participation in other drug or medical device clinical trials within 3 months prior to study drug administration, or planned participation during the study; 16.Subjects with special dietary requirements or inability to comply with the study center’s dietary restrictions; 17.Any other condition deemed by the investigator to make the subject unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemoglobin Level; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hepatic Function; | — |
Countries
China
Contacts
Public ContactZhongyuan Xu
Southern Medical University Southern Hospital
Outcome results
None listed