Compound Ciwujia Granules Treat Chronic Fatigue Syndrome

NCT06245642 | Completed Phase 4

• 1 other identifier: FFCWJKE-RCT-002
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 1

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%

Conditions

Chronic Fatigue Syndrome

Outcome Measures

Primary Outcomes (1)

• 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%

  Screening/Baseline period (Week -2 to Day 0), Treatment period (Week 3 ± 5 days), Treatment period (Week 6 ± 5 days)

Secondary Outcomes (3)

• Changes in Chalder scale scores and sub-scores

  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

  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

  Screening/Baseline period (Week -2 to Day 0), Treatment period (Week 3 ± 5 days), Treatment period (Week 6 ± 5 days)

Study Arms (2)

Positive control group

ACTIVE COMPARATOR

Guipi Granules + Compound Ciwujia Granules simulator

Drug: Compound Ciwujia Granules, Guipi Granules

Experimental group

EXPERIMENTAL

Compound Ciwujia Granules + Guipi Granules simulator

Drug: Compound Ciwujia Granules, Guipi Granules

Interventions

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.

Also known as: Primary therapy

Experimental group; Positive control group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Heilongjiang Quanle Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shanghai Shuguang Hospital, Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200000, China

Location

Related Publications (11)

• Holmes GP, Kaplan JE, Gantz NM, Komaroff AL, Schonberger LB, Straus SE, Jones JF, Dubois RE, Cunningham-Rundles C, Pahwa S, et al. Chronic fatigue syndrome: a working case definition. Ann Intern Med. 1988 Mar;108(3):387-9. doi: 10.7326/0003-4819-108-3-387.

  PMID: 2829679 BACKGROUND

• Wu Qiao, Gao Jing, Bo Ding Xi, etc. Meta-analysis of prevalence of chronic fatigue syndrome in Chinese population [J]. Youjiang Med, 2019,48(10):727-735. (in Chinese) DOI:10.3969/j.issn.1003-1383.2020.10.002.

  BACKGROUND

• Maher KJ, Klimas NG, Fletcher MA. Chronic fatigue syndrome is associated with diminished intracellular perforin. Clin Exp Immunol. 2005 Dec;142(3):505-11. doi: 10.1111/j.1365-2249.2005.02935.x.

  PMID: 16297163 BACKGROUND

• Kang Meihua. Chronic fatigue syndrome [J]. International journal of pediatrics, 2011, 42 (5) : 516-518521. The DOI: 10.3760 / cma. J.i SSN. 1673-4408.2011.05.029.

  BACKGROUND

• Qing · Yu Jing. Synopsis of Golden Chamber. Kuang Huitao, tidy up. Taiyuan: Shanxi Science and Technology Press, 2012:94-9. (in Chinese [6] Rong Haibo, Zhang Shiming. Professor Zhang Shiming Chinese medicine classification diagnostic criteria of exercise fatigue. Journal of Chengdu University of Traditional Chinese Medicine [J], 2017,40 (4):72.

  BACKGROUND

• Man Shanshan, Bian Yuhong, Gu Zhimin, et al. Analysis of anti-fatigue mechanism of traditional Chinese medicine. Tianjin Pharmacy [J], 2014, 26(2):62-65. (in Chinese)

  BACKGROUND

• Zhang Shan. Protective effect and mechanism of Acanthopanax injection on cardiotoxicity and cerebral ischemic injury [D]. Tianjin: Tianjin Medical University, 2019.

  BACKGROUND

• Wang Bingzhu. Huangdi's internal channels [M]. Beijing: The Commercial Press, 1955:59

  BACKGROUND

• Fukuda K,StrcdusS.HickieI,eta1．The chornic fatiyue syndrome:a comprehensive approach it，Sdenfinition and study[J]．Annal of internal Mendicine，1994,121：953-959．

  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

  BACKGROUND

• Yuan Wan-Li, KANG Ming-xiang, WU Zhi-Hui, YU Ping. Chronic fatigue syndrome of traditional Chinese medicine standard of clinical research [J]. Journal of shaanxi traditional Chinese medicine, 2009, 30 (5) : 515-517. The DOI: 10.3969 / j.i SSN. 1000-7369.2009.05.001.

  BACKGROUND

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Xiaotian Zhang, Master

  Shanghai Shuguang Hospital, Shanghai University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

• Weian Yuan, Doctor

  Shanghai Shuguang Hospital, Shanghai University of Traditional Chinese Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 7, 2024
• Study Start: March 19, 2024
• Primary Completion: January 16, 2025
• Study Completion: January 16, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)