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A multicenter, randomized, placebo-controlled clinical study of Renshen Guben oral Liquid in the treatment of post-COVID-19 fatigue syndrome

A multicenter, randomized, placebo-controlled clinical study of Renshen Guben oral Liquid in the treatment of post-COVID-19 fatigue syndrome

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069518
Enrollment
Unknown
Registered
2023-03-20
Start date
2023-03-20
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

post-COVID-19 fatigue syndrome

Interventions

Observation group:Renshen Guben oral liquid
Control group:Placebo

Sponsors

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria for post-COVID-19 fatigue syndrome; (2) Meet the diagnostic criteria of TCM Qi and Yin deficiency syndrome; (3) Age 18-70, gender unlimited; (4) The patient agreed to join the clinical study, voluntarily signed the informed consent, and agreed to participate in the visit, examination and treatment according to the requirements of the research protocol.

Exclusion criteria

Exclusion criteria: (1) combined with mental illness, such as severe anxiety and severe depression; (2) Secondary fatigue caused by drugs or other reasons; (3) patients with serious primary diseases of cardiovascular and cerebrovascular systems, liver, kidney and hematopoietic systems, malignant tumors, and other serious complications; (4) Pregnant or lactating women; (5) have received relevant treatment and may affect the observed effect indicators; (6) Patients suspected of having a history of drug abuse or other ineligible patients. (7) Allergic constitution and allergic to the drug. (8) Patients with uncontrolled hypertension (DBP > 100mmHg or SBP > 160 mmHg)

Design outcomes

Primary

MeasureTime frame
Chalder scale score;

Secondary

MeasureTime frame
TCM syndrome score;EQ-5D-5L Quality of Life questionnaire score;CRP;TNF-a;IL-6;IL-8;CD3+ cell;CD4+ cell;CD8+ cell;NK cell;blood routine examination;hepatic and renal function;

Countries

China

Contacts

Public ContactGuang Ji

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

jiliver@vip.sina.com13816018198

Outcome results

None listed

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