CClinicalTrials.gg
Sign In
CompletedNCT06245642Updated Sep 23, 2025

Compound Ciwujia Granules Treat Chronic Fatigue Syndrome

A Phase 4 interventional study of Compound Ciwujia Granules, Guipi Granules in Chronic Fatigue Syndrome, sponsored by Heilongjiang Quanle Pharmaceutical Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-09-23.

Sponsored by Heilongjiang Quanle Pharmaceutical Co., Ltd. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
235
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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%

Read the 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 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.

02

Conditions studied

  • Chronic Fatigue Syndrome
03

In context

Fatigue Syndrome, Chronic

246 studies on the registry are indexed under Fatigue Syndrome, Chronic; 58 are open to participants now.

This study's enrollment of 235 is above the median of 60 across 166 interventional studies indexed under Fatigue Syndrome, Chronic.

Browse Fatigue Syndrome, Chronic studies →

Lead sponsor

This is the only study on the registry with Heilongjiang Quanle Pharmaceutical Co., Ltd. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
235 participants (actual)

Study arms

  • Active comparator
    Positive control group

    Guipi Granules + Compound Ciwujia Granules simulator

    Drug: Compound Ciwujia Granules, Guipi Granules

  • Experimental
    Experimental group

    Compound Ciwujia Granules + Guipi Granules simulator

    Drug: Compound Ciwujia Granules, Guipi Granules

Interventions

  • DrugCompound Ciwujia Granules, Guipi Granules

    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

06

What researchers measure

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%

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

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)

07

Study locations

1 site
  • Shanghai Shuguang Hospital, Shanghai University of Traditional Chinese Medicine
    Shanghai, Shanghai Municipality 200000, China
08

References and documents

Publications

  • 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. PubMed 2829679 ↗
  • 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.
  • 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. PubMed 16297163 ↗
  • 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.
  • 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.
  • 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)
  • Zhang Shan. Protective effect and mechanism of Acanthopanax injection on cardiotoxicity and cerebral ischemic injury [D]. Tianjin: Tianjin Medical University, 2019.
  • Wang Bingzhu. Huangdi's internal channels [M]. Beijing: The Commercial Press, 1955:59
  • 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．
  • 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
  • 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.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06245642
Lead sponsor
Heilongjiang Quanle Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Feb 7, 2024
Start date
Mar 19, 2024
Primary completion
Jan 16, 2025
Completion
Jan 16, 2025
Last update
Sep 23, 2025

Study contacts

Xiaotian Zhang, Master
principal investigator · Shanghai Shuguang Hospital, Shanghai University of Traditional Chinese Medicine
Weian Yuan, Doctor
principal investigator · Shanghai Shuguang Hospital, Shanghai University of Traditional Chinese Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Fatigue Syndrome, Chronic→

Start the discussion