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Efficacy and safety of Orostachydis Herba extracts in immune function improvement : a single center, randomised, double blind, placebo-controlled, clinical trial

Efficacy and safety of Orostachydis Herba extracts in immune function improvement : a single center, randomised, double blind, placebo-controlled, clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0002123
Enrollment
62
Registered
2016-10-28
Start date
2017-02-01
Completion date
Unknown
Last updated
2019-03-11

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

Conditions

None listed

Interventions

Dietary Supplement : Orostachydis Herba group receive 1g of Orostachydis Herba extracts, once a day, for 8 weeks. Placebo group receive 1g of dextrin, once a day, for 8 weeks.

Sponsors

Pusan National University Korean Medicine Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) adult male and female over the age of 45 (2) Those who can visit for follow up while study period, and can have examination which measured in this study including the blood collection (3) Those who decided to voluntarily participate in this clinical trial, and signed research agreement(informed consent)

Exclusion criteria

Exclusion criteria: (1) Those with diseases or conditions that may affect the immune system (Ex: Infectious diseases, autoimmune diseases, blood diseases, malignant neoplasms, such as distinct malnutrition) (2) Those who took drug that may affect the immune system (Ex: steroid, hormone) or may affect absorption, metabolism and excretion of trial food within a month recently. (3) Those with gastrointestinal diseases, operation (except for a simple appendectomy surgery or hernia surgery) which may affect absorption of trial food (4) Those with hypersensitivity reactions or side effects on Orostachydis Herba or similar plants (5) Those who intake Excessive alcohol - Male: more than 168g/week (about 3.5bottles/week as soju(Korean distilled spirits), about 12bottles/week as beer) - Female: more than 112g/week (about 2.3bottles/week as soju(Korean distilled spirits), about 8bottles/week as beer) (6) Pregnant women, nursing mothers and fertile women not using adequate contraception. (7) Those deemed inappropriate to participate this clinical trial by research personnel or research director, due to other reasons

Design outcomes

Primary

MeasureTime frame
The ratio of NK cell(percentage of NK cell among lymphocyte);The ratio of T-helper cell and T-suppressor cell(percentage of CD4+/CD8+ T cell)

Secondary

MeasureTime frame
Total numbers of Blood leukocytes(WBC);The ratio of neutrophil, lymphocyte, monocyte among leukocyte;The ratio of T cell, T-helper cell, T-suppressor cell, B cell among Lymphocytes;amount of blood IgM, IgG, IgA, CMV IgG;blood metabolome analysis target & gobal analysis (LC/MS)

Countries

Korea, Republic of

Contacts

Public ContactJinyong Choi

Pusan National University Korean Medicine Hospital

cjy9005@naver.com+82-55-360-5555

Outcome results

None listed

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