Compound Xiwujia Granules Treat Chronic Fatigue Syndrome
- Conditions
- Chronic Fatigue Syndrome
- Interventions
- Drug: Compound Xiwujia granule + Guipi granule
- Registration Number
- NCT06245642
- Lead Sponsor
- Heilongjiang Quanle Pharmaceutical Co., Ltd.
- 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 Xiwujia granules + Guipi granules/placebo (experimental group) and compound Xiwujia 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 236
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Positive control group Compound Xiwujia granule + Guipi granule Guipi Granule + compound Xiwujia granule simulator Experimental group Compound Xiwujia granule + Guipi granule Compound Xiwujia granule + Guipi granule simulator
- Primary Outcome Measures
Name Time Method The subjects' Chalder scale scores changed after 3 and 6 weeks of treatment Treatment for 3 weeks and 6 weeks As a previous multicenter RCT data on CFS showed that the higher the Chalder scale score at baseline, the more the score decreased after treatment. Therefore, in order to reduce the difference in efficacy caused by baseline,the investigators used the nimodipine efficacy calculation method to evaluate the changement of Chalder scale score.
Calculation: changement =\[(baseline score - post-treatment score)/baseline score\]\*100% The Chalder Fatigue Score (CFQ-11) is a total score of 0-33, with higher scores reflecting more severe fatigue
- Secondary Outcome Measures
Name Time Method Changes in Chalder scale scores and sub-scores Treatment for 3 weeks and 6 weeks Calculation: Changement =\[(baseline score - post-treatment score)/baseline .The Chalder Fatigue Score (CFQ-11) is a total score of 0-33, with higher scores reflecting more severe fatiguescore\]\*100%
The change of TCM syndrome score Treatment for 3 weeks and 6 weeks Calculation: Changement =\[(baseline score - post-treatment score)/baseline score\]\*100% .TCM syndrome（SCM) score is a scale of 0-42, with higher scores indicating more severe disease states.
Changes in scores of EQ-5D-5L Quality of Life questionnaire Treatment for 3 weeks and 6 weeks Calculation: Changement =\[(baseline score - post-treatment score)/baseline score\]\*100%.The EQ-5D-5L Quality of Life questionnaire (EQ-5D-5L)is scored on a scale of 0-100, with higher scores indicating a better state of affairs.
Trial Locations
- Locations (1)
Weian Yuan
🇨🇳Shanghai, Shanghai, China