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Clinical Study on Chai-shi-Jie-Du granules in Treating Dengue Fever

Clinical Study on Chai-shi-Jie-Du granules in Treating Dengue Fever

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001995
Enrollment
Unknown
Registered
2025-10-22
Start date
2023-09-05
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dengue fever

Interventions

Experimental group:Symptomatic treatment+Chai-shi-Jie-Du granules
Placebo group:Symptomatic treatment+Placebo of Chai-shi-Jie-Du granules

Sponsors

Guangzhou Eighth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. All cases of dengue fever (acute febrile phase) that meet the diagnostic criteria; 2. Individuals (or their guardians) who agree to participate in a randomized controlled trial and sign an informed consent form; 3. Body temperature >38°C, with symptom onset time =3 days; 4. Age: 18-65 years old; 5. Primary symptoms include fever, chills, red tongue, thick or greasy tongue coating, and soft, slippery, and rapid pulse; belonging to the pattern of damp-heat stagnation with simultaneous involvement of defensive and nutrient qi.

Exclusion criteria

Exclusion criteria: 1. Patients with concomitant bacterial infections; 2. Patients with viral hepatitis (excluding viral carriers), post-hepatitic cirrhosis, HIV/AIDS, or other acute infectious diseases; 3. Patients with concomitant hematological disorders; 4. Patients with immune-mediated diseases such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma, psoriasis, or inflammatory bowel disease; 5. Patients with severe underlying diseases or conditions deemed unsuitable for trial participation by investigators (e.g., severe respiratory diseases, cirrhosis, malignant tumors, chronic congestive heart failure, chronic renal insufficiency/history of hemodialysis, cardiovascular/cerebrovascular diseases, or severe psychiatric disorders); 6. Patients presenting with any of the following clinical manifestations: severe abdominal pain, persistent vomiting, chest tightness/palpitations, lethargy/agitation, significant bleeding tendency (mucosal bleeding or extensive skin ecchymosis), arrhythmia, pleural effusion, ascites, or deep jaundice; 7. Pregnancy or suspected pregnancy (pregnancy testing required prior to enrollment; pregnant patients excluded); 8. Patients with severe dengue (e.g., severe bleeding, altered consciousness, or shock); 9. Patients with suspected hypersensitivity to the investigational drug or concurrent participation in another clinical trial.

Design outcomes

Primary

MeasureTime frame
Defervescence time;Platelet recovery time;Complication Incidence Rate;Critical conversion rate;Time and degree of viral load reduction;

Secondary

MeasureTime frame
Time to Symptom Relief or Resolution;Adverse Reactions and Adverse Events;

Countries

China

Contacts

Public ContactXinghua Tan

Artemisinin Research Center,Guangzhou University of Chinese Medicine

gz8htxh@126.com+86 13500039656

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026