Skip to content

Research on the immune response level of Yiqi Zengmian Prescription after the third dose of inactivated COVID-19 vaccine--A multicenter, randomized, double-blind, placebo-parallel controlled clinical research

Research on the immune response level of Yiqi Zengmian Prescription after the third dose of inactivated COVID-19 vaccine--A multicenter, randomized, double-blind, placebo-parallel controlled clinical research

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200005641
Enrollment
Unknown
Registered
2022-02-15
Start date
2022-02-01
Completion date
Unknown
Last updated
2023-02-20

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

Conditions

COVID-19

Interventions

Control group:Take placebo for 21 days
Intervention group:Take Yiqi Zengmian prescription for 21 days

Sponsors

Xiyuan Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 59 Years

Inclusion criteria

Inclusion criteria: 1) Aged 18-59; 2) Those who have completed two doses of inactivated COVID-19 vaccine 6 months prior and have not received the third dose; 3) Agree to participate in this study.

Exclusion criteria

Exclusion criteria: 1) Those who have experienced transient and severe adverse reactions after vaccination, or had severe allergic reactions to vaccines, such as acute anaphylaxis, urticaria, skin eczema, dyspnea, angoneeurotic edema or abdominal pain, etc., which are judged by researchers be in high risk. 2) Those who are allergic to the ingredients in yiqi Zengmian Prescription. 3) Those who have fever, acute disease, severe chronic disease, in the acute onset of chronic disease. 4) Pregnant women and lactating women have a birth plan within 6 months of vaccination. 5) Those who have the history of convulsion, epilepsy, encephalopathy,Guillain-Barre syndrome or mental illness or family history, or uncontrolled epilepsy and other progressive neurological disorders. 6) Those who have been diagnosed as congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia, or other autoimmune disease. 7) Those who have or suspected to have serious respiratory diseases, serious cardiovascular diseases, liver and kidney diseases, or malignant tumors. 8) Those who have the history of novel coronavirus infection. 9) Those who are taking or took drugs that may affect immune function, such as immunosuppressants or immunoenhancers or glucocorticoids (=10mg prednisone or other equivalent glucocorticoids), within one month prior to enrollment. 10) Researchers think it is not suitable for who to receive Traditional Chinese medicine.

Design outcomes

Primary

MeasureTime frame
RBD specific antibody;

Secondary

MeasureTime frame
Neutralizing antibody;Adverse Event;Cytokines;Immune cell phenotype;TCM constitution questionnaire;

Countries

China

Contacts

Public ContactQing Miao
miaoqing55@sina.com13910812309

Outcome results

None listed

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