NCT05592093

Effect of Korean Red Ginseng on Oxidation in Middle-aged and Elderly Sub-health Population

An RCT Study to Investigate the Effect of Korean Red Ginseng for Middle-aged and Elderly Sub-health Population on Anti-oxidation

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 900 (actual)
• Sponsor: Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to examine the effects and safety of Korean red ginseng capsule and placebo with middle-aged and elderly sub-health population.

Detailed description

Processed red ginseng are non-toxic and healthy "tonics". It was recorded in medical books and Materia Medica that taking it for a long time can prolong life. The main purpose of this study is to evaluate the effect of ginseng on antioxidation and healthy aging indicators of sub-health subjects in Han Chinese population. Subjects will undergo a safety follow-up after the treatment period. Safety and efficacy will be determined by looking at a number of assessments \[physical examinations, blood sampling, sub-health status evaluation questionnaire (shsq-25), etc.\]. It is expected that around 900 people (at least 450 in each arm) with sub-healthy state may take part in the study. The study participants will be recruited at around 3 sites from Northern(Beijing),Central(Shanghai), Southern(Foshan and Nanchang) in China.

Conditions

• Healthy Ageing
• Antioxidative Stress

Interventions

Type	Name	Description
DRUG	Korean red ginseng capsule (marketed product in Korea)	Korean red ginseng capsule (marketed product in Korea) KRGO group and placebo group were used for treatment. The random number is generated by the central randomization system. All the recruiters were divided into placebo group and KRGO group. The numbers will be assigned according to random numbers. In this study, qualified subjects were randomly assigned to the KRGO group and placebo group at a ratio of 1:1. The drug was administered for 12 weeks, 2 times a day, 3 capsules each time.
DRUG	Korean red ginseng capsule(placebo)	KRGO group and placebo group were used for treatment. The random number is generated by the central randomization system. All the recruiters were divided into placebo group and KRGO group. The numbers will be assigned according to random numbers. In this study, qualified subjects were randomly assigned to the KRGO group and placebo group at a ratio of 1:1. The drug was administered for 12 weeks, 2 times a day, 3 capsules each time.

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-10-30
• Completion: 2024-12-10
• First posted: 2022-10-24
• Last updated: 2026-01-21

Locations

4 sites across 1 country: China