NCT06245642CompletedPhase 4
Compound Ciwujia Granules Treat Chronic Fatigue Syndrome
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)
Source: ClinicalTrials.gov · Last updated 23 Sept 2025
Brief summary (registry, in English)
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%
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 235 (actual)
- First submitted
- 24 Jan 2024
- Start date
- 19 Mar 2024
- Primary completion date
- 16 Jan 2025
- Lead sponsor
- Heilongjiang Quanle Pharmaceutical Co., Ltd.
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT06245642
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 235
- From 19 Mar 2024 to the primary completion date, 16 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Secondary fatigue caused by drugs or other reasons;
- Have received relevant treatment and may affect the observed effect indicators;
Other illness
- Combined with mental disorders such as severe anxiety and severe depression;
- 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);
Lab values
- 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;
Other
- Women who are pregnant, breastfeeding or who may become pregnant in the study and cannot use effective contraception;
- Diabetic patients;
- Those that the researcher thinks are not suitable for participating in this study.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Shuguang Hospital, Shanghai University of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.