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NCT Number: NCT06245642

Compound Ciwujia Granules Treat Chronic Fatigue Syndrome

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%

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Key information

Conditions

Chronic Fatigue Syndrome Chronic Disease Disease Attributes Encephalomyelitis Fatigue Syndrome, Chronic Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuroinflammatory Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shanghai Shuguang Hospital, Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Compound Ciwujia Granules, Guipi Granules

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.

Other names: Primary therapy

Primary outcomes

  1. The subjects' Chalder scale scores changed after 3 and 6 weeks of treatment

    Time frame: 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 outcomes

  1. 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)

  2. 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)

  3. 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)

Sponsors and collaborators

Lead sponsor

Heilongjiang Quanle Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Multi-center, Randomized, Double-blind, Positive Parallel Control Study of Compound Ciwujia Granules in the Treatment of Chronic Fatigue Syndrome (Spleen-kidney Deficiency Syndrome, Heart-spleen Deficiency Syndrome)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 7, 2024
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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