Compound Xiwujia Granules Treat Chronic Fatigue Syndrome

Chronic Fatigue Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06245642
• Other study ID #: FFCWJKE-RCT-002
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: March 1, 2024
• Est. completion date: November 1, 2025

Study information

• Verified date: February 2024
• Source: Heilongjiang Quanle Pharmaceutical Co., Ltd.
• Contact: Weian Yuan, Doctor
• Phone: 13774269261
• Email: weian_1980[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 236
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Fatigue Syndrome
• Fatigue
• Fatigue Syndrome, Chronic
• Syndrome

Intervention

Drug:
• Compound Xiwujia granule + Guipi granule
Experimental group: Basic treatment + compound Xiwujia granules + Guipi granules simulator orally for 6 weeks Positive drug control group: basic treatment + Guipi granule + compound Xiwujia granule simulant Koufu for 6 weeks

Locations

Country	Name	City	State
China	Weian Yuan	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Heilongjiang Quanle Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

References & Publications (11)

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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 — View Citation

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.

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

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. — View Citation

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)

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

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

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.

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. 1000-7369.2

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

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The subjects' Chalder scale scores changed after 3 and 6 weeks of treatment	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	Treatment for 3 weeks and 6 weeks
Secondary	Changes in Chalder scale scores and sub-scores	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%	Treatment for 3 weeks and 6 weeks
Secondary	The change of TCM syndrome score	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.	Treatment for 3 weeks and 6 weeks
Secondary	Changes in scores of EQ-5D-5L Quality of Life questionnaire	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.	Treatment for 3 weeks and 6 weeks