Qishe Pill（Shanghai Sundise Traditional Chinese Medicine Co., Ltd, China） in low dosage(3.75mg)

Qishe Pill（Shanghai Sundise Traditional Chinese Medicine Co., Ltd, China) in medial dosage(7.5mg)

Qishe Pill（Shanghai Sundise Traditional Chinese Medicine Co., Ltd, China）in high dosage(15mg)

Individuality

Narrative Medicine

Qishe Pill is a thin 0.15 g film-coated pill, composed of processed Radix Astragali, Muscone, Szechuan Lovage Rhizome, Radix Stephaniae Tetrandrae, Ovientvine, and Calculus Bovis Artifactus, which should be taken orally with water (240mL) after a minimum 10-hour fast

Qishe Pill

Longhua Hospital, Shanghai University of TCM

PopPK Profile of Qishe Pill: Study Protocol for a Phase I Clinical Trial

Population Pharmacokinetic Modeling of Qishe Pill in Three Major TCM-defined Constitutional Types of Healthy Chinese Subjects: Study Protocol for a Phase I Clinical Trial

5 ml blood samples for pharmacokinetic analysis

body temperature, heart rate and blood pressure

The investigators will assess all clinical AEs according to the Medical Dictionary for Regular Activities criteria, in terms of intensity (mild, moderate, or severe), duration, outcome and relationship to the study drug.

Subjects will be requested to return to the study unit 4 d after drug administration and blood sampling for a follow-up visit.

The area under the plasma concentration-time curve (AUC) will be calculated using the linear trapezoidal rule.

The distribution volume (DF) will be calculated by Dose/AUC/ke. ke is the elimination rate constant.

3 ml blood samples for genomic variants analysis. The cytochrome P450 gene family, such as CYP1A1, CYP1A2, CYP2D6, CYP2C9, CYP2C19, CYP2E1, CYP3A4 and CYP3A5 , etc, will be chosen as the target objective.

Two qualified traditional Chinese medical doctors licensed by the Chinese government determine the constitution according to CCMQ

These parameters including blood count, electrolytes, renal and liver function parameters, blood lipids, age, gender, history of smoking, blood pressure, weight (kg), and height (meters) will be obtained for all subjects.

Cui xuejun

Vice director

Shanghai University of Traditional Chinese Medicine

Cervical Radiculopathy

Qishe Placebo

No.1 Hospital, Changchun University of TCM

Gansu Hospital of TCM

Huadong Hospital

Longhua Hospital

Suzhou Hospital of TCM

Qishe Pill for Cervical Radiculopathy

Effectiveness of a Compound Traditional Chinese Herbal Medicine, Qishe Pill, on Cervical Radiculopathy: a Randomized, Double-blind, Placebo-controlled, Multicentre Trial

Operationally, the VAS score display as a horizontal line, 100 mm in length, word descriptors anchored at each end. The patient marks on the line the point that they feel represents their perception of their current pain. The VAS score is then determined by measuring in millimetres from the left hand end of the line to the point that the patient marks.

levisticum officinale/neck pain

PopPK Profile of Qishe Pill: Study Protocol for a Phase I Clinical Trial

Qishe Pill for Cervical Radiculopathy

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