Skip to content

A randomized, double-blind, placebo-controlled, multicenter clinical trial to evaluate the efficacy and safety of Zengjian Health Tonic in enhancing immune function

A randomized, double-blind, placebo-controlled, multicenter clinical trial to evaluate the efficacy and safety of Zengjian Health Tonic in enhancing immune function

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102182
Enrollment
Unknown
Registered
2025-05-09
Start date
2025-02-13
Completion date
Unknown
Last updated
2025-05-19

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

Conditions

Decrease in immune function

Interventions

Experimental product group:Take Zengjian Health Tonic orally, one bottle each time, three times a day, for 90 days
Placebo group:Take placebo orally, one bottle each time, three times a day, for 90 days

Sponsors

The Second Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 74 Years

Inclusion criteria

Inclusion criteria: 1. Age 45-74 years old (inclusive), gender is not limited; 2. The comprehensive evaluation score of the immune-related health score =60 and the score of the Immune Status Questionnaire (ISQ) = 2 times per year, (3) Prone to acute diarrhea (except for food intolerance such as lactose and wheat gum) >=3 times per year, (4) Those who have been infected with the new crown; 4. Those who voluntarily enrolled and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Those who have a history of allergy to the ingredients of the test product or are allergic. 2. Women who are pregnant or preparing to become pregnant and lactating women. 3. Patients with serious diseases and mental illness such as heart, brain, liver, kidney and hematopoietic system. 4. Subjects have immune-related diseases such as systemic lupus erythematosus, rheumatoid arthritis, systemic vasculitis, scleroderma, pemphigus, dermatomyositis, mixed connective tissue disease, primary thrombocytopura, autoimmune hemolytic anemia, Hashimoto's thyroiditis, primary myxedema, hyperthyroidism, ulcerative colitis, etc. 5. Those who have used and enhanced immune-related health foods and drugs within 3 months will affect the judgment of results. 6. Those who have participated in other clinical trials within 3 months prior to induction.

Design outcomes

Primary

MeasureTime frame
Quantitative Score of Immune Level;Immune-Related Health Score;Immune Status Questionnaire;

Secondary

MeasureTime frame
Immune cell detection;White blood cell differentiation;Immunoglobulin and Complement;Markers of Chronic Inflammation;Chinese Medicine Syndrome Score;Self-Assessment Table for Classification and Determination of Constitution in Traditional Chinese Medicine;Health Status Survey Questionnaire;

Countries

China

Contacts

Public ContactYang Yang

The Second Hospital of Anhui Medical University

iamyy1208333@163.com+86 551 6386 9420

Outcome results

None listed

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