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%
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
235
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.
Shanghai Shuguang Hospital, Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
The subjects' Chalder scale scores changed after 3 and 6 weeks of treatment
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%
Time frame: Screening/Baseline period (Week -2 to Day 0), Treatment period (Week 3 ± 5 days), Treatment period (Week 6 ± 5 days)
Changes in Chalder scale scores and sub-scores
Time frame: 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
Time frame: 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
Time frame: Screening/Baseline period (Week -2 to Day 0), Treatment period (Week 3 ± 5 days), Treatment period (Week 6 ± 5 days)
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