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Research plan for clinical safety evaluation of Guipi mixture after its market launch

Clinical safety evaluation of Guipi mixture after its launch

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ITMCTR
Registry ID
ITMCTR2026000204
Enrollment
Unknown
Registered
2026-01-28
Start date
2026-02-07
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Deficiency of both the heart and spleen, shortness of breath and palpitations, insomnia with excessive dreaming, dizziness and lightheadedness, fatigue and weakness in the limbs, and loss of appetite

Interventions

Gui Pi Mixture Group:Establish a single-arm observation group, without interfering with clinical medication decisions, and only conduct safety monitoring.

Sponsors

Shenzhen Traditional Chinese Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age = 4 years old, = 80 years old, gender not limited; 2. Patients who meet the indications specified in the instructions for Guipi mixture or are deemed suitable for the use of Guipi mixture by clinical physicians based on the patient's condition, and for whom a prescription has been issued for the use of Guipi mixture; 3. Patients who voluntarily participate and sign informed consent forms; 4. Continuous medication for more than 14 days is considered as one case.

Exclusion criteria

Exclusion criteria: Researchers determine that patients who cannot complete or are not suitable to participate in this study (such as those with advanced malignant tumors mental illness, inability to cooperate with monitoring, severe liver and kidney dysfunction, etc.)

Design outcomes

Primary

MeasureTime frame
adverse event;

Countries

chinese

Contacts

Public ContactChen Jun

Shenzhen Traditional Chinese Medicine Hospital

chenj_zyy@sina.com0755-88609648

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 7, 2026