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Chronic Fatigue SyndromePhase 4NCT06245642

Compound Ciwujia Granules Treat Chronic Fatigue Syndrome

A Phase 4 study testing Compound Ciwujia Granules, Guipi Granules in people with Chronic Fatigue Syndrome, run by Heilongjiang Quanle Pharmaceutical Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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% Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Chronic Fatigue Syndrome
What is being tested?
Compound Ciwujia Granules, Guipi Granules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
235 participants
Where
1 siteChina
Study dates
19 Mar 2024to 16 Jan 2025
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Shuguang Hospital, Shanghai University of Traditional Chinese Medicine

    Shanghai, Shanghai Municipality, 200000

Other trials in China

About this study

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

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.

Being tested
Compound Ciwujia Granules, Guipi Granules
Medical subject headings
Fatigue Syndrome, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Compound Ciwujia Granules, Guipi GranulesDrug

    Also called Primary therapy

    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.

Study groups in NCT06245642
Study groupRoleWhat they receive
Positive control groupActive comparatorGuipi Granules + Compound Ciwujia Granules simulator
Receives: Drug: Compound Ciwujia Granules, Guipi Granules
Experimental groupExperimentalCompound Ciwujia Granules + Guipi Granules simulator
Receives: Drug: Compound Ciwujia Granules, Guipi Granules

What is being measured

The primary outcome is the main question the study is designed to answer.

  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%

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

Secondary outcomes (3)

  1. Changes in Chalder scale scores and sub-scores

    Measured: 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

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2024
  2. Study start19 Mar 2024
  3. Primary completion16 Jan 2025
  4. Study completion16 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
235 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06245642
Sponsor's protocol ID
FFCWJKE-RCT-002
Status last verified
Sep 2025
First submitted
24 Jan 2024
Last updated
23 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Compound Ciwujia Granules, Guipi Granules in people with Chronic Fatigue Syndrome, run by Heilongjiang Quanle Pharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The subjects' Chalder scale scores changed after 3 and 6 weeks of treatment (time frame: Screening/Baseline period (Week -2 to Day 0), Treatment period (Week 3 ± 5 days), Treatment period (Week 6 ± 5 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06245642, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.

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