A Randomized Controlled Multicenter Study on the Improvement of Postoperative Symptoms and Survival Benefits of Modified Bufei Decoction in Elderly Patients With Lung Cancer Undergoing Radical Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- MDASI-TCM scale
研究概览
简要总结
This is a randomized double-blind placebo-controlled phase II clinical study that included patients with symptoms such as cough, shortness of breath, and fatigue after lung cancer resection surgery. They were given orally modified Bufei Tang granules twice a day for 28 days, with one packet taken orally with water. Using the MDASI-TCM symptom scoring system, evaluate the scores of symptoms such as cough, shortness of breath, and fatigue before and after the experiment, and calculate the difference in scores between the control group and the experimental group before and after the experiment.
详细描述
This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial to verify the effectiveness of the traditional Chinese medicine compound Jiawei Bufei Tang in improving postoperative clinical symptoms in elderly lung cancer patients and providing effective treatment methods for improving patients' quality of life.
- Research Design: A multicenter, randomized double-blind placebo-controlled study was conducted, in which eligible subjects were randomly assigned to a treatment group and a control group in a 1:1 ratio, with 87 cases in each group.
- The process of participant participation in the experiment The composition of Jiawei Bu Fei Tang includes Huangqi, Codonopsis pilosula, Schisandra chinensis, Rehmannia glutinosa, Ziyuan, Mulberry bark, Snake berry, Half branch lotus, White Hedyotis diffusa, Bai Qian, and Platycodon grandiflorum. A traditional Chinese medicine placebo is formulated with caramel color, dextrin, and bittering agent to create a placebo with an appearance and taste similar to the treatment group's medication. Both the therapeutic drug and placebo were tested using independently packaged non decoction granules produced by the same company and batch.
On the 7th day after surgery, patients were screened and evaluated using the MDASI-TCM scale. Subjects with postoperative symptoms such as fatigue, cough, and shortness of breath who met the inclusion criteria but did not meet the exclusion criteria were included in the clinical study and randomly assigned to receive oral medication treatment in a 1:1 ratio.
On the day of inclusion, the patient was randomized and successfully received the trial medication, with the first oral administration of traditional Chinese medicine within 24 hours.
Treatment group (Modified Bufei Decoction):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with postoperative lung cancer who have clear histological or cytological diagnosis.
- •Age ≥ 65 years old, both male and female are eligible. According to the MDASI-TCM scale evaluation, any of the three symptoms of cough, fatigue, and shortness of breath should score ≥ 4 points, or the sum of the three should score ≥ 6 points.
- •The heart function is basically normal; ALT/AST is within 2 times the normal value; SCr is within the normal range.
- •Traditional Chinese medicine syndrome differentiation is characterized by deficiency of both lungs and kidneys.
排除标准
- •Patients with severe pulmonary infections. ⑵. Patients with mental illness. ⑶. Patients with depression.
研究组 & 干预措施
Jiawei Bufei Tang
Oral administration of Jiawei Bufei Tang granules for 28 days, twice a day, 1 packet each time, and the medication must be taken with water.
干预措施: Jiawei Bufei Tang granules (Other)
Placebo granules
Take placebo granules orally for 28 days, twice a day, 1 pack each time, and the medication must be taken with water.
干预措施: Placebo (Drug)
结局指标
主要结局
MDASI-TCM scale
时间窗: 28 days
The symptom score results of the MDASI-TCM scale between the oral Chinese medicine group and the placebo group after 28 days of medication.
次要结局
- QLQ-C30 scale(28 days)
- CGA assessment(28 days)
- DFS(28 days)