A Multi-center, Randomized, Double-blind, Positive Parallel Control Study of Compound Ciwujia Granules in the Treatment of Chronic Fatigue Syndrome (Spleen-kidney Deficiency Syndrome, Heart-spleen Deficiency Syndrome)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 235
- 试验地点
- 1
- 主要终点
- The subjects' Chalder scale scores changed after 3 and 6 weeks of treatment
研究概览
简要总结
To observe the improvement of Chalder scale score in patients with chronic fatigue syndrome treated by Compound Ciwujia Granules. Improvement =[(baseline score - post-treatment score)/baseline score]*100%
详细描述
After being informed of the study and potential risks, all subjects who have given informed consent undergo a 2-week screening period to determine eligibility, and on day 0, subjects who meet eligibility requirements will be randomly assigned in a double-blind way. The patients were treated with Compound Ciwujia Granules + Guipi Granules/placebo (experimental group) and Compound Ciwujia Granules/placebo + Guipi Granules (positive control group) at a ratio of 1:1 for 6 weeks. Compound Ciwujia Granules/placebo 8g per bag, 2 times a day, 1 bag each time, Guipi Granules, 3g per bag, taken with boiling water. 1 bag (3g) at a time, 3 times a day.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria of Western medicine for chronic fatigue syndrome;
- •Meet the diagnostic criteria of spleen and kidney deficiency syndrome or heart and spleen deficiency syndrome of traditional Chinese medicine;
- •Chalder scale score greater than 12 points;
- •Age 18-70 years old, gender is not limited;
- •Agree to participate in this clinical study, voluntarily sign informed consent, and agree to participate in visits, examinations, and treatments according to the requirements of the research protocol.
排除标准
- •Combined with mental disorders such as severe anxiety and severe depression;
- •Secondary fatigue caused by drugs or other reasons;
- •Patients with serious primary diseases such as cardiovascular and cerebrovascular, liver, kidney and hematopoietic system, malignant tumors, and other serious complications; Abnormal liver and kidney function ALT, AST≥ 1.5 times the upper limit of normal value, Cr > the upper limit of normal value;
- •Women who are pregnant, breastfeeding or who may become pregnant in the study and cannot use effective contraception;
- •Have received relevant treatment and may affect the observed effect indicators;
- •Suspected to have a history of drug abuse or other patients who do not meet the eligibility criteria;
- •Allergic physique and allergic to the drug;
- •Uncontrolled hypertension (DBP > 100mmHg or SBP > 160 mmHg);
- •Diabetic patients;
- •Those that the researcher thinks are not suitable for participating in this study.
研究组 & 干预措施
Positive control group
Guipi Granules + Compound Ciwujia Granules simulator
干预措施: Compound Ciwujia Granules, Guipi Granules (Drug)
Experimental group
Compound Ciwujia Granules + Guipi Granules simulator
干预措施: Compound Ciwujia Granules, Guipi Granules (Drug)
结局指标
主要结局
The subjects' Chalder scale scores changed after 3 and 6 weeks of treatment
时间窗: Screening/Baseline period (Week -2 to Day 0), Treatment period (Week 3 ± 5 days), Treatment period (Week 6 ± 5 days)
Based on the results of a multicenter RCT on CFS conducted earlier, it was found that the higher the baseline Chalder scale score, the greater the decrease in the score after treatment. Therefore, to reduce the differences in efficacy caused by the baseline, we used the nimodipine efficacy calculation method to evaluate the improvement in Chalder scale scores. Calculation method: Improvement = \[(Baseline score - Post-treatment score) / Baseline score\] \* 100%
次要结局
- Changes in Chalder scale scores and sub-scores(Screening/Baseline period (Week -2 to Day 0), Treatment period (Week 3 ± 5 days), Treatment period (Week 6 ± 5 days))
- Changes in TCM syndrome scores and sub-scores(Screening/Baseline period (Week -2 to Day 0), Treatment period (Week 3 ± 5 days), Treatment period (Week 6 ± 5 days))
- Changes in scores of EQ-5D-5L Quality of Life questionnaire(Screening/Baseline period (Week -2 to Day 0), Treatment period (Week 3 ± 5 days), Treatment period (Week 6 ± 5 days))