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A multicenter, randomized, double-blind, placebo, parallel controlled clinical trial study on traditional Chinese medicine treatment in the recovery period of COVID-19 infection population

A multicenter, randomized, double-blind, placebo, parallel controlled clinical trial study on traditional Chinese medicine treatment in the recovery period of COVID-19 infection population

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080348
Enrollment
Unknown
Registered
2024-01-26
Start date
2024-01-29
Completion date
Unknown
Last updated
2024-01-28

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

Conditions

Recovery from COVID-19 infection

Interventions

experimental group:According to the type of syndrome, the subjects were given Gubenfuyuan granule and Sanshen Laifu respectively Granule or Shenling Fukang granule.
control group:At the same time, simulants with the same packaging, dosage form, color and smell as the "three medicines" are applied.

Sponsors

The Affiliated Hospital of Hunan Academy of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age = 18 years old =75 years old (without any co-morbidity, age can be relaxed to 80 years old and below), both male and female; 2. Patients who meet the diagnostic criteria for the convalescence period of COVID-19 infection; 3. Those who meet the diagnostic criteria of lung, spleen and kidney deficiency, Qi and Yin deficiency syndrome, spleen and lung Qi deficiency syndrome; 4. Can provide contact details, no short-term migration intention, can be willing to cooperate with the visitor; 5. Voluntarily participate and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with severe hepatic and renal insufficiency (severe hepatic insufficiency is defined as ALT >2 times the upper limit of normal or AST >2 times the upper limit of normal; Severe renal insufficiency is defined as Cr value >1.5 times the upper limit of normal); 2. Severe pulmonary dysfunction [FEV1 % of expected value (including obstruction or limitation) : severe: 35% ~ 49%; extremely severe: <35%; or DLCO % of expected value: <40%; or for all measures, use Z-value: severe: <-4.1]; 3. Patients with diseases of blood, immune and tumor systems; 4. Pregnant or breastfeeding; 5. Test drug contraindications and allergies; 6. Participants in other clinical trials in the last 3 months; 7. Persons with serious mental illness; 8. Patients with a history of drug rash or allergic reaction to drugs; 9. People who are currently infected with influenza viruses such as swine flu and are taking antiviral drugs.

Design outcomes

Primary

MeasureTime frame
Therapeutical effective rate;Total clinical symptom scores;

Secondary

MeasureTime frame
FAS Fatigue Rating Scale;VAS Pain Visual Analogue Scale;SF-36 Health Survey Scale;TCM syndrome score;

Countries

China

Contacts

Public ContactGe Jinwen Wu DAhua

Hunan Academy of Traditional Chinese Medicine

40831556@qq.com+86 138 7317 2948

Outcome results

None listed

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