Compound Xiwujia Granules Treat Chronic Fatigue Syndrome

Heilongjiang Quanle Pharmaceutical

Status and phase: Not yet enrolling; Phase 4

Conditions: Chronic Fatigue Syndrome

Treatments: Drug: Compound Xiwujia granule + Guipi granule

Study type: Interventional

Funder types: Industry

Identifiers

NCT06245642

FFCWJKE-RCT-002

Details and patient eligibility

About

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%

Full 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.

Enrollment: 236 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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236 participants in 2 patient groups, including a placebo group

Positive control group

Placebo Comparator group

Description:

Guipi Granule + compound Xiwujia granule simulator

Treatment:

Drug: Compound Xiwujia granule + Guipi granule

Experimental group

Experimental group

Description:

Compound Xiwujia granule + Guipi granule simulator

Treatment:

Drug: Compound Xiwujia granule + Guipi granule