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

Phase 1

• Conditions: COVID-19

• Registration Number: ITMCTR2200005641
• Lead Sponsor: Xiyuan Hospital, China Academy of Chinese Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

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

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
RBD specific antibody;

Secondary Outcome Measures

Name	Time	Method
eutralizing antibody;Adverse Event;Cytokines;Immune cell phenotype;TCM constitution questionnaire;