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Human experimental study on the effect of Huoxiang Suling Shuanghua Decoction on enhancing immunity and vaccine titer

Further study of Huoxiang Suling Shuanghua Decoction

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200005544
Enrollment
Unknown
Registered
2022-01-17
Start date
2022-01-17
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 vaccinations people

Interventions

Experimental group:Continuous administration of Huoxiang Suling Shuanghua Decoction for 7 days
Control group:Placebo was given for seven days

Sponsors

School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing, China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) The subjects were aged from 18 to 65 years old and had no history of sars-cov-2 infection. (2) The varieties of new crown vaccine inoculated in two or three doses shall be produced by the same manufacturer, and the specific type shall be selected according to the actual situation of the enrolled population. (3) Those who meet the requirements of new crown vaccination and have received the second or third injection of new crown vaccine, and the time from the end of the last injection is within 48 hours. (4) The interval between the first two injections of the new crown vaccine is within 21 ~ 28 days. Depending on the current vaccination situation of the new crown vaccine, the interval between the second and third injections can be extended to 6 months, which is in line with the specified interval of the vaccine. (5) There is no serious discomfort within 24 hours after the second or third injection. (6) Those who sign the informed consent form.

Exclusion criteria

Exclusion criteria: (1) Those with a history of sars-cov-2 infection. (2) Those who do not meet the requirements of new crown vaccination. (3) those with underlying diseases and who are taking medicine [hypertension, grade three, high risk, high risk, cirrhosis (decompensated liver function), uremia, kidney dialysis, diabetes mellitus (complicated with severe complications), nephrotic syndrome, sequelae of cerebrovascular disease (serious dysfunction)]. (4) Patients with clinically significant acute diseases or body temperature = 38 ?, clinical manifestations in line with covid-19, and any prohibition of new crown vaccine within 24 hours before the planned injection of the second or third dose of vaccine, including pregnant women. (5) Severe adverse reactions such as thrombosis and poor breathing occurred within 24 hours after the second or third injection.

Design outcomes

Primary

MeasureTime frame
Immunogenicity of COVID-19 vaccine;

Secondary

MeasureTime frame
Serum levels of interleukin-6 (IL-6) and interferon -? (IFN-?);7 immunity items in serum (IgA, IgG, total IgE, IgM, C3, C4, CH50);Serum T subsets (CD3+, CD4+, CD8+);Metabolomics method was used to detect the metabolic changes of serum samples of subjects, and explore the immune regulation mechanism (validity index was detected first in the project experiment, and the mechanism study of this part was carried out after the effectiveness was proved).;

Countries

China

Contacts

Public ContactLinyuan Wang

School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing, China

wangly@bucm.edu.cn13381002202

Outcome results

None listed

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