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The Efficacy and Safety of Shenqi Fuzheng Injection for the Treatment of Cancer-related Fatigue in Patients(Palliative Care) With Digestive Tract Were Prospectively, Randomized Blind, Multicenter Clinical Trials

0 criterios cumplidosConsulta de un vistazo cómo tu perfil cumple con cada criterio de elegibilidad.
Qué se está evaluando

shenqifuzheng injection

+ Sodium Chloride Injection 0.9%

Medicamento
Quiénes están siendo reclutados

De 18 a 80 años
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Controlado con Placebo
Intervencional
Inicio del estudio: enero de 2018
Ver detalles del protocolo

Resumen

Patrocinador PrincipalLivzon Pharmaceutical Group Inc.
Contacto del Estudiolin lizhu, Dr.
Última actualización: 27 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 18 de enero de 2018

Fecha en la que se inscribió al primer participante.

Factors for the purpose of this study by observing theShenqifuzheng injection before and after treatment in patients with carcinoma due to fatigue scale scores, the classification of syndromes, the quality of life score changes and related laboratory index, evaluation factors ginseng and astragalus injection on the digestive tract tumor (chemotherapy) in patients with cancer-related fatigue and quality of life improved efficacy and safety. The experimental group was randomly divided into 2 groups, experimental group Shenqifuzheng injection of 500 ml. The control group was 0.9% sodium chloride injection, 500ml, intravenous drip, 1 time daily, 14 days for continuous use, 7 days of rest, and 1 treatment for each 21 days, and 2 courses were observed. At the same time, according to the NCCN guide and the health ministry issued the diagnosis and treatment guidelines for cancer treatment. Main efficacy evaluation indexes before and after treatment for cancer-related fatigue rating - adopting the Piper fatigue scale revised Chinese version, compare the experimental group and the control group before and after treatment cancer-related fatigue rating difference have differences. Secondary efficacy evaluation index to compare the ECOG score difference before and after the treatment, the quality of life score difference before and after the treatment, TCM syndrome curative effect, single symptom curative effect of immune function, tumors had curative effect (if any) and chemotherapy completion. Safety assessment includes the observation of vital signs, blood routine, urinary routine, routine stool, liver function, renal function, electrocardiogram examination, and adverse reactions during the treatment.

Título OficialThe Efficacy and Safety of Shenqi Fuzheng Injection for the Treatment of Cancer-related Fatigue in Patients(Palliative Care) With Digestive Tract Were Prospectively, Randomized Blind, Multicenter Clinical Trials
NCT03456609
Patrocinador PrincipalLivzon Pharmaceutical Group Inc.
Contacto del Estudiolin lizhu, Dr.
Última actualización: 27 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 60 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Tratamiento

Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

De 18 a 80 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Criterios

Inclusion Criteria: * 1\. Patients with gastric cancer, esophageal cancer or colorectal cancer diagnosed by pathology or cytology; * 2\. Diagnostic criteria for cancer-related fatigue; * 3\. Syndrome differentiation of Chinese medicine is a syndrome of lung temper; * 4\. Estimated survival over 3 months; * 5\. ECOG score is less than or equal to 3 * 6\. Age 18 \~ 80 years old; * 7\. Non-surgical indications or reluctance to operate the surgical treatment; * 8\. 70 g/L or higher HGB; * 9\. Stop and chemotherapy for more than 1 month; * 10\. The patient is willing to accept the treatment of the programme, and can follow the doctor's advice to take the medicine and comply with the patient. Exclusion Criteria: * 1\. Any situation that may hinder the subject from completing the clinical trial, including but not limited to serious, uncontrollable organic disease or infection: 1. clinically significant cardiovascular diseases, such as heart failure (NYHA III-IV), uncontrolled coronary heart disease, cardiomyopathy, arrhythmia, etc. 2. serious clinical infection of activity (greater than 3 degrees nci-ctcae 4.03) 3. uncontrolled hypertension (systolic pressure is greater than 160 mmHg or diastolic pressure is greater than 100 mmHg, despite the best drug treatment); 4. severe liver and kidney function abnormality (blood creatinine is greater than 1.5 times ULN; ALT or AST is greater than 5 times ULN; Bilirubin is greater than 1.5 times ULN. 5. other diseases that need to be controlled: pulmonary congestion, etc. * 2\. Patients with symptoms, uncontrollable nerves, mental illness or mental disorders; * 3\. Compliance.

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

2 grupos de intervención están designados en este estudio

50% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental

Grupo II

Placebo

Objetivos del Estudio

Objetivos Primarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene una ubicación

Reclutando

First affiliated hospital of guangzhou university of traditional Chinese medicine

Guangzhou, ChinaAbrir First affiliated hospital of guangzhou university of traditional Chinese medicine en Google Maps
Suspendido1 Centros de Estudio