Chronic Fatigue Syndrome
Conditions
Brief summary
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%
Detailed description
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.
Interventions
DRUGCompound Ciwujia Granules, Guipi Granules
Experimental group: Basic treatment + Compound Ciwujia Granules + Guipi Granules simulator orally for 6 weeks; Positive drug control group: basic treatment + Guipi Granules + Compound Ciwujia Granules simulant orally for 6 weeks.
Sponsors
Heilongjiang Quanle Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The subjects' Chalder scale scores changed after 3 and 6 weeks of treatment | 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% |
Secondary
| Measure | Time frame |
|---|---|
| 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) |
Countries
China
Outcome results
None listed