Compound Ciwujia Granules Treat Chronic Fatigue Syndrome

NCT ID: NCT06245642

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 235 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-19
• Study Completion Date: 2025-01-16

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.

Conditions

Chronic Fatigue Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Positive control group

Guipi Granules + Compound Ciwujia Granules simulator

Group Type: ACTIVE_COMPARATOR

Compound Ciwujia Granules, Guipi Granules

Intervention Type: DRUG

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.

Experimental group

Compound Ciwujia Granules + Guipi Granules simulator

Group Type: EXPERIMENTAL

Compound Ciwujia Granules, Guipi Granules

Intervention Type: DRUG

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.

Interventions

Compound 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.

Intervention Type: DRUG

Other Intervention Names

Primary therapy

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heilongjiang Quanle Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaotian Zhang, Master

Role: PRINCIPAL_INVESTIGATOR

Shanghai Shuguang Hospital, Shanghai University of Traditional Chinese Medicine

Weian Yuan, Doctor

Role: PRINCIPAL_INVESTIGATOR

Shanghai Shuguang Hospital, Shanghai University of Traditional Chinese Medicine

Locations

Shanghai Shuguang Hospital, Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

Countries

China

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

Luo Ren, Kuang Rijian, ZHAO Xiaoshan, Huang Jianhua, Clinical Guidelines for the treatment of chronic fatigue syndrome with new Chinese medicines [C]. Chinese Association of Chinese Medicine Sub-Health Branch General election and

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

Other Identifiers

FFCWJKE-RCT-002

Identifier Type: -

Identifier Source: org_study_id