Clinical trial NCT06245642: Compound Xiwujia Granules Treat Chronic Fatigue Syndrome
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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Chronic Fatigue Syndrome
Lead sponsor: Heilongjiang Quanle Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-02-07
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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.

Primary outcomes:
measure: The subjects' Chalder scale scores changed after 3 and 6 weeks of treatment
timeFrame: Treatment for 3 weeks and 6 weeks
Secondary outcomes:
measure: Changes in Chalder scale scores and sub-scores
timeFrame: Treatment for 3 weeks and 6 weeks
measure: The change of TCM syndrome score
timeFrame: Treatment for 3 weeks and 6 weeks
measure: Changes in scores of EQ-5D-5L Quality of Life questionnaire
timeFrame: Treatment for 3 weeks and 6 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Weian Yuan
state: Shanghai
Study officials:
affiliation: Principal Investigator
name: Xiaotian Zhang, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
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.
citation: 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.
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)
citation: Zhang Shan. Protective effect and mechanism of Acanthopanax injection on cardiotoxicity and cerebral ischemic injury [D]. Tianjin: Tianjin Medical University, 2019.
citation: Wang Bingzhu. Huangdi's internal channels [M]. Beijing: The Commercial Press, 1955:59
citation: 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．
citation: 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
citation: 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.