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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%
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Positive control group | Active Comparator | Guipi Granules + Compound Ciwujia Granules simulator |
|
| Experimental group | Experimental | Compound Ciwujia Granules + Guipi Granules simulator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Shuguang Hospital, Shanghai University of Traditional Chinese Medicine | Shanghai | Shanghai Municipality | 200000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2829679 | Background | 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. | |
| 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. | ||
| 16297163 |
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| ID | Term |
|---|---|
| D015673 | Fatigue Syndrome, Chronic |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D004679 | Encephalomyelitis |
| D000090862 | Neuroinflammatory Diseases |
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|
| 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) |
| 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. |
| 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. |
| D009422 | Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |