Abstract
Purpose
The purpose of this study was to evaluate the efficacy and safety of red ginseng oil (RXGIN) in men with lower urinary tract symptoms.
Materials and Methods
Men aged between 40 and 75 years with a total International Prostate Symptom Score (IPSS) of 8 to 19 points were recruited from April 2020 to December 2020. Subjects were randomly assigned to either the RXGIN group or the control group in a 1:1 ratio and received either RXGIN or placebo daily for 12 weeks. For the primary outcome, changes in IPSS scores at 6 and 12 weeks from baseline were analyzed. The secondary outcomes were changes in International Index of Erectile Function (IIEF), maximum urinary flow rate, and post-void residual volume at weeks 6 and 12 compared to baseline. Urine analysis and blood tests were additionally performed for safety assessment.
Results
A total of 88 subjects (RXGIN group, 46; control group, 42) completed the study. The total IPSS and IPSS subscores (residual urine sensation, frequency, intermittency, urgency, weak stream, straining, nocturia, and quality of life) were significantly improved in the RXGIN group compared to the control group at weeks 6 and 12. Total IIEF and sexual desire were significantly improved in the RXGIN group at week 6 and week 12, respectively, but there were no significant changes in the level of serum testosterone or dihydrotestosterone. The serum prostate-specific antigen showed significant decrease at weeks 12. No serious adverse events leading to discontinuation of the study drug were observed in the RXGIN group.
Conclusions
Red ginseng oil (RXGIN) appears to be safe and effective in improving lower urinary tract symptoms in men and may also improve some aspects of sexual function.
Keywords: Erectile dysfunction, Lower urinary tract symptoms, Panax, Phytotherapy
INTRODUCTION
Lower urinary tract symptoms (LUTS) are a common condition that can affect both men and women, especially as they age [1]. Treatment of LUTS includes lifestyle modification, medication, or surgical intervention, but the number of cases not receiving treatment due to old age or underlying disease is increasing. Therefore, treatment using herbal medicines that are effective but have few side effects is being studied in the medical field [2,3].
Alpha adrenergic blockers are the grade A moderate recommendation by the American Urological Association guidelines for treatment of LUTS due to benign prostatic hypertrophy (BPH), but headache, dizziness, and retrograde ejaculation are common side effects [4]. In addition, 5-alpha reductase inhibitors can reduce the incidence of complications such as acute urinary retention by reducing prostate volume but have side effects such as impotence, decreased libido, and ejaculation disorder [5,6]. Therefore, there is need for research on LUTS treatment using herbal medicines with limited side effects.
With the known main biological effects of red ginseng (Ginseng Radix Rubra, Hongsam in Korean) including strengthening immunity, restoring vitality, relieving fatigue, improving blood flow, antioxidant effect, improving memory, and positive effects on menopausal and erectile disorders [7,8], it has been traditionally used in East Asia, including Korea, Japan, and China.
Red ginseng oil contains mainly non-saponin-based active ingredients and is rich in fatty acids such as linoleic acid and plant sterols such as β-sitosterol [9]. In particular, clinical studies have shown that β-sitosterol is effective for BPH patients with LUTS [10]. In addition, studies have demonstrated the potential of red ginseng oil for BPH treatment in two animal models [11,12]. Accordingly, the present clinical trial was a randomized, double-blind, placebo-controlled trial designed to confirm the therapeutic effects and safety of RXGIN, an extract of red ginseng oil, in male patients suffering from moderate LUTS.
MATERIALS AND METHODS
1. Preparation of RXGIN (red ginseng oil) and study design
Preparation of RXGIN is referenced in a previous preclinical study [11], and all products (red ginseng and placebo) used in the study were provided by the Korea Ginseng Corporation (Daejeon, Korea).
Red ginseng was extracted seven times with water and dried to a powder. The powder underwent a supercritical CO2 fluid extraction process (supercritical fluid extraction system; Ilshin Autoclave Co., LTD.) to produce red ginseng oil. Then, 500 mg of RXGIN was encapsulated in a dark brown soft formulation for ease of use by the test group.
The clinical trial assessment group was administered two RXGIN 500 mg capsules once a day (1,000 mg per day). The placebo group received two capsules of the same appearance and taste once a day. Test subjects consumed RXGIN or placebo every day for 12 weeks and visited the clinic at the 6th and 12th weeks to undergo blood tests and urine analysis, to answer questionnaires (International Prostate Symptom Score [IPSS], International Index of Erectile Function [IIEF]), and to undergo uroflowmetry.
Patients who agreed to participate in this clinical trial were randomly assigned to either the RXGIN group or placebo group in a 1:1 ratio. The inclusion criteria were as follows: 1) Male between 40 and 75 years old and 2) Patients with a Total IPSS score of 8 to 19.
The exclusion criteria were as follows: 1) Patients undergoing treatment for malignant tumors; 2) Patients with a serum prostate-specific antigen (PSA) concentration of 4.0 ng/mL or higher; 3) Patients with a maximum urinary flow rate (Q max) less than 5 mL/sec or residual urine volume exceeding 150 mL; 4) Patients who had undergone prostate surgery; 5) Patients with uncontrolled hypertension or diabetes; 6) and any other patients whose medical condition was determined to be problematic to participate in this study.
The sample size for the clinical trial was calculated with the following conditions: 1) superiority test; 2) level of significance was 5%, two-sided test; 3) Use a type 2 error (β) of 0.2 to keep the power of test at 80%; 4) The ratio of the number of trials in the test and control groups was 1:1; 5) Among the existing studies, the confidence interval and significance probability of the preand post-intake values of the test drug were used from the results of the study by Noguchi et al [13], which showed significant results for the IPSS. Accordingly, the targeted minimum number of subjects was 37 for each group, and we decided to recruit up to 50 subjects for each group to account for a 25% dropout rate.
2. Outcome measures
The primary outcome was changes in IPSS scores between the RXGIN and placebo groups at 6 and 12 weeks of the trial compared to baseline.
The secondary outcomes were changes in IIEF, Q max, and post-void residual volume (PVR) at 6 and 12 weeks of the trial compared to baseline in each group. Additionally, changes in serum PSA and testosterone (total testosterone, free testosterone, dihydrotestosterone [DHT]) levels at 12 weeks of the trial were compared to baseline in each group.
3. Safety assessment
The safety set was defined as all subjects who had received at least one dose of RXGIN or placebo. Participants were instructed to immediately report any adverse reactions that occurred after consuming the test products. In addition, medical evaluations were conducted to assess adverse reactions based on blood and urine tests conducted at 6 and 12 weeks of the trial. Blood tests were performed for red blood cells, white blood cells, hemoglobin, hematocrit, platelet, neutrophil, lymphocyte, monocyte, and eosinophil counts, as well as levels of basophils, aspartate aminotransferase, alanine aminotransferase, guanosine triphosphate, total protein, albumin, glucose, total bilirubin, Na, K, Cl, creatinine, BUN, uric acid, total cholesterol, triglycerides, and high-density lipoprotein and low-density lipoprotein cholesterol. Urine analysis measured levels of S.G, pH, nitrite, protein, glucose, ketone, urobilinogen, and bilirubin.
4. Statistical analysis
Statistical analysis was performed using SAS (version 9.4; SAS Institute), and p-values less than 0.05 were considered statistically significant for all analyses. Safety set analysis was performed on the group of subjects who had consumed the test agent or placebo at least once after randomization. For intra-group comparisons in primary and secondary outcome analyses, paired t-tests were used, while comparisons between the test and control groups at each time point were performed using two sample t-tests or Wilcoxon rank sum tests based on data normality assumption. p-values for inter-group comparisons were adjusted for age and body mass index (BMI).
5. Ethical statement
This trial was approved by the Institutional Review Board (IRB) of The Catholic University of Korea (IRB no. KC20HDSE0064). It was conducted in accordance with the declaration of Helsinki and the International Conference on Harmonisation of Good Clinical Practice Guidelines. The study was also approved by the Clinical Research Information Service of South Korea (CRIS No: KCT0008453).
RESULTS
1. Baseline characteristics
From April 2020 to December 2020, 116 participants were enrolled, 14 of whom were excluded during screening, leaving 102 patients (RXGIN, n=52; control, n=50) to be assigned to the clinical trial. In the test group, 4 participants withdrew consent and 2 dropped out due to low compliance. In the control group, 5 withdrew consent, 1 experienced an adverse reaction requiring cessation of treatment, and 2 were excluded for use of prohibited medications. A final total of 88 participants completed the trial (RXGIN, n=46; control, n=42). The CONSORT diagram is shown in Supplement Fig. 1.
The mean age of all participants was 62.53±8.29 years, with a mean age of 63.24±7.88 years for the RXGIN group and 62.53±8.29 years for the control group. The mean BMI of all participants was 24.65±2.52 kg/m2, with a mean of 24.80±2.87 kg/m2 for the RXGIN group and 24.49±2.10 kg/m2 for the control group. There were no significant differences in age or BMI between the groups. More details of baseline comorbidities of each group, including diabetes, hypertension, hyperlipidemia and etc. are summarized in Supplement Table 1.
2. Primary outcomes (IPSS)
Table 1 summarizes the changes in IPSS score after 6th and 12th weeks compared to baseline for each test group. For total IPSS score, significant improvements were observed in the RXGIN group compared to the placebo group at both the 6th week (7.02±3.24 vs. 13.50±4.02; p<0.0001) and the 12th week (5.87±2.50 vs. 13.38±4.57; p<0.0001).
Table 1. Changes in IPSS scores of each groups.
| RXGIN (n=46) | Placebo (n=42) | p-valuea | p-valueb | ||
|---|---|---|---|---|---|
| Total IPSS | 11.87±2.70 | 12.90±3.20 | 0.1497 | ||
| Baseline | 11.87±2.70 | 12.90±3.20 | 0.1497 | ||
| 6th week | 7.02±3.24 | 13.50±4.02 | <0.0001 | <0.0001 | |
| 12th week | 5.87±2.50 | 13.38±4.57 | <0.0001 | <0.0001 | |
| Residual urine sensation | |||||
| Baseline | 1.80±0.98 | 2.02±1.30 | 0.5947 | ||
| 6th week | 0.87±0.83 | 2.12±1.19 | <0.0001 | <0.0001 | |
| 12th week | 0.83±0.68 | 1.90±1.28 | <0.0001 | <0.0001 | |
| Frequency | |||||
| Baseline | 1.63±1.25 | 1.83±1.06 | 0.3281 | ||
| 6th week | 0.76±0.92 | 1.88±1.15 | 0.0002 | <0.0001 | |
| 12th week | 0.57±0.69 | 1.67±1.18 | <0.0001 | <0.0001 | |
| Intermittency | |||||
| Baseline | 1.80±1.17 | 2.24±1.12 | 0.0946 | ||
| 6th week | 1.24±1.10 | 2.40±1.21 | 0.0005 | <0.0001 | |
| 12th week | 1.00±0.94 | 2.31±1.35 | <0.0001 | <0.0001 | |
| Urgency | |||||
| Baseline | 0.91±0.96 | 1.17±1.08 | 0.2636 | ||
| 6th week | 0.41±0.62 | 1.24±0.93 | 0.0058 | <0.0001 | |
| 12th week | 0.28±0.50 | 1.40±1.21 | <0.0001 | <0.0001 | |
| Weak stream | |||||
| Baseline | 2.91±1.07 | 2.88±1.11 | 0.9446 | ||
| 6th week | 1.87±1.11 | 2.90±1.27 | <0.0001 | <0.0001 | |
| 12th week | 1.83±1.00 | 2.95±1.34 | <0.0001 | <0.0001 | |
| Straining | |||||
| Baseline | 1.35±0.95 | 1.21±1.14 | 0.3710 | ||
| 6th week | 0.83±0.77 | 1.29±1.17 | 0.0141 | 0.0176 | |
| 12th week | 0.52±0.66 | 1.40±1.04 | <0.0001 | <0.0001 | |
| Nocturia | |||||
| Baseline | 1.46±0.78 | 1.55±0.92 | 0.4955 | ||
| 6th week | 1.04±0.70 | 1.67±0.95 | 0.0010 | <0.0001 | |
| 12th week | 0.85±0.63 | 1.74±0.91 | 0.0001 | <0.0001 | |
| Quality of life | |||||
| Baseline | 3.24±0.79 | 3.71±0.67 | 0.3560 | ||
| 6th week | 2.80±0.91 | 3.64±0.62 | 0.0137 | 0.0003 | |
| 12th week | 2.46±0.50 | 3.50±0.74 | 0.0010 | <0.0001 | |
Values are presented as mean±standard deviation.
IPSS: International Prostate Symptom Score, RXGIN: red ginseng oil.
aCompared changes between groups; p-value for Wilcoxon rank sum test.
bCompared changes between groups; p-value for generalized linear model adjusted baseline, age, body mass index.
Overall, the RXGIN group demonstrated significant improvements across all assessed IPSS subscores compared to the placebo group; in residual urine sensation, frequency, intermittency, urgency, weak stream, straining, and nocturia scores at 6th and 12th weeks. Additionally, improvements in the quality of life were observed in the RXGIN group at both 6th week and 12th week.
Fig. 1 shows changes in IPSS scores by IPSS total score, IPSS voiding subscore (sum of residual urine sensation, intermittency, weak stream, and straining subscores), IPSS storage subscore (sum of frequency, urgency, and nocturia subscores), and quality of life subscore.
Fig. 1. Changes in International Prostate Symptom Score (IPSS) of each groups: (A) total IPSS score, (B) IPSS voiding subscore, (C) IPSS storage subscore, and (D) quality of life subscore. RXGIN: red ginseng oil.
3. Secondary outcomes
1) International Index of Erectile Function-5 score
Table 2 summarizes the changes in IIEF-5 score for each test group at 6 and 12 weeks compared to baseline. The IIEF total score was significantly improved at 12 weeks (p=0.0013, p=0.0423) in the RXGIN group compared with the placebo group. Among the IIEF subscores, sexual desire was significantly increased in the RXGIN group compared to placebo at 6 weeks (p=0.0144, p=0.0168) and 12 weeks (p=0.0073, p=0.0165). Erectile function, orgasmic function, and intercourse satisfaction subscores were also significantly improved at 12 weeks (p=0.0047, p=0.0204, and p=0.0452) in the RXGIN group compared with the placebo group without adjusting for age and BMI. The sexual desire subscore was significantly improved in the RXGIN group compared to the control group at 6 weeks (p=0.0144, p=0.0168) and 12 weeks (p=0.0073, p=0.0165), while overall satisfaction did not show a significant difference between the groups.
Table 2. Changes in IIEF scores of each groups.
| RXGIN (n=46) | Placebo (n=42) | p-valuea | p-valueb | ||
|---|---|---|---|---|---|
| Total IIEF-5 | |||||
| Baseline | 27.83±18.89 | 34.67±22.23 | 0.1834 | ||
| 6th week | 33.80±21.61 | 35.64±22.07 | 0.0713 | 0.6168 | |
| 12th week | 35.65±22.84 | 34.50±21.71 | 0.0013 | 0.0423 | |
| Erectile function | |||||
| Baseline | 2.76±3.51 | 3.98±4.09 | 0.1735 | ||
| 6th week | 3.74±4.12 | 4.24±4.11 | 0.3436 | 0.8735 | |
| 12th week | 4.22±4.53 | 3.90±4.01 | 0.0204 | 0.0699 | |
| Sexual desire | |||||
| Baseline | 6.07±1.82 | 6.48±1.67 | 0.2465 | ||
| 6th week | 6.72±1.63 | 6.24±1.71 | 0.0144 | 0.0168 | |
| 12th week | 6.96±1.40 | 6.45±1.48 | 0.0073 | 0.0165 | |
| Intercourse satisfaction | |||||
| Baseline | 3.20±4.03 | 4.69±4.80 | 0.1149 | ||
| 6th week | 4.15±4.52 | 4.81±4.60 | 0.1488 | 0.8640 | |
| 12th week | 4.43±4.76 | 4.40±4.45 | 0.0452 | 0.1005 | |
| Overall satisfaction | |||||
| Baseline | 5.63±1.51 | 5.90±1.72 | 0.3488 | ||
| 6th week | 6.02±1.48 | 6.07±1.70 | 0.6988 | 0.9728 | |
| 12th week | 6.33±1.48 | 6.02±1.58 | 0.0819 | 0.0594 | |
Values are presented as mean±standard deviation.
IIEF-5: International Index of Erectile Function-5, RXGIN: red ginseng oil.
aCompared changes between groups; p-value for Wilcoxon rank sum test.
bCompared changes between groups; p-value for generalized linear model adjusted baseline, age, body mass index.
2) Serum PSA and dihydrotestosterone & testosterone
Changes in baseline of the RXGIN and control groups at week 12 are summarized in Table 3. The serum PSA significantly decreased by the 12 weeks (p=0.0211) before adjustment for age and BMI. There was no significant difference in total testosterone, free testosterone, or DHT between the RXGIN and control groups at the 12 weeks compared to baseline.
Table 3. Changes in serum PSA, testosterone (total and free), DHT levels, Q max, and PVR of each groups.
| RXGIN (n=46) | Placebo (n=42) | p-valuea | p-valueb | ||
|---|---|---|---|---|---|
| PSA (ng/mL) | |||||
| Baseline | 1.29±0.86 | 1.32±0.79 | 0.5065 | ||
| 12th week | 1.25±0.81 | 1.37±0.83 | 0.0296 | 0.2076 | |
| Total testosterone (ng/mL) | |||||
| Baseline | 4.12±1.50 | 3.50±1.33 | 0.1630 | ||
| 12th week | 4.20±1.57 | 3.64±1.22 | 0.7549 | 0.8430 | |
| Free testosterone (pg/mL) | |||||
| Baseline | 8.45±2.52 | 7.72±2.30 | 0.0868 | ||
| 12th week | 9.23±2.93 | 8.10±1.95 | 0.5871 | 0.1685 | |
| DHT (pg/mL) | |||||
| Baseline | 393.74±142.10 | 392.21±132.30 | 0.9168 | ||
| 12th week | 415.81±125.66 | 400.20±116.07 | 0.1404 | 0.3022 | |
| Q max (mL/sec) | |||||
| Baseline | 13.89±6.14 | 13.54±6.35 | 0.7572 | ||
| 6th week | 15.42±6.34 | 15.21±8.05 | 0.9700 | 0.6949 | |
| 12th week | 15.11±7.10 | 14.73±8.45 | 0.5201 | 0.5588 | |
| PVR (mL) | |||||
| Baseline | 20.24±22.29 | 17.14±17.27 | 0.6579 | ||
| 6th week | 15.13±12.89 | 17.57±18.59 | 0.7860 | 0.5002 | |
| 12th week | 17.37±24.63 | 23.14±58.73 | 0.6609 | 0.3058 | |
Values are presented as mean±standard deviation.
RXGIN: red ginseng oil; PSA: prostate-specific antigen, DHT: dihydrotestosterone, Q max: maximum urinary flow rate, PVR: post-void residual volume.
aCompared changes between groups; p-value for Wilcoxon rank sum test.
bCompared changes between groups; p-value for generalized linear model adjusted baseline, age, body mass index.
3) Maximum urinary flow rate and post-void residual volume
Changes in Q max and PVR at 6 and 12 weeks compared to baseline in the RXGIN and placebo groups are summarized in Table 3. Q max tended to increase and PVR tended to decrease in the RXGIN group, although there was no significant difference compared to the placebo group.
4. Safety assessment
In the study, a safety set consisting of 51 subjects in the RXGIN group and 50 subjects in the placebo group was analyzed. Among them, 1 case (headache) in the RXGIN group and 1 case (rash) in the control group experienced an adverse reaction that was considered to be related to the clinical trial products. The subject in the RXGIN group with headache fully recovered without treatment and continued with the clinical trial, while the subject in the control group with rash voluntarily discontinued the test product and fully recovered from the symptoms. No adverse reactions caused by the RXGIN or placebo were found in the blood and urine tests conducted at 6 and 12 weeks, and there was no significant difference between and within the intake groups. Also, systolic blood pressure, diastolic blood pressure, pulse, and weight were checked at 6 and 12 weeks, without significant changes from the baseline.
DISCUSSION
To the best of our knowledge, this is the first randomized, double-blind, placebo-controlled clinical trial study to confirm improvement of LUTS and sexual dysfunction with red ginseng treatment. Over the past decades, many efficacy studies have been conducted and published on red ginseng in Korea and Japan. Recently, it has been found to be effective in maintaining the balance of PGI2 and TXA2, physiologically active substances that play a major role in thrombosis and arteriosclerosis [14]. RXGIN, which is extracted from red ginseng, contains a very high content of β-sitosterol among phytosterols. β-sitosterol is a type of provitamin D, a precursor to vitamin D, that is widely used in treatments for arteriosclerosis, angina, myocardial infarction, cerebrovascular disease, and diabetes, all caused by cholesterol accumulation [15]. A prospective study announced that vitamin D can be effective for LUTS [16], and additionally, a recent clinical study related to BPH using enriched β-sitosterol, have confirmed significant improvements in IPSS, Aging Males’ Symptoms, and Androgen Deficiency in Aging Males scores comparing to low dose placebo [17].
In a previous multicenter trial of saw palmetto, the concentration of β-sitosterol was 0.2%. The storage symptoms, voiding symptoms, and IIEF were significantly improved by week 24. Without change in the serum PSA [18]. On the other hand, RXGIN in this study, with a β-sitosterol concentration of 6.96% [11], already showed significant improvements in IPSS and IIEF scores compared to placebo at week 6 and 12.
Johnson et al [19] reported that tamsulosin had more severe side effects of ejaculation disorder, dizziness, and nasal congestion compared to placebo. Wessells et al [20] reported that 22% of patients taking finasteride had side effects such as decreased libido, impotence, and ejaculation disorder, and 4% stopped taking the drug because of sexual dysfunction. In contrast, the only side effect considered to be related to RXGIN in the present clinical study was headache, which occurred in only one of 51 test patients and resolved naturally without any special measures and did not result in subject drop out.
From the secondary outcomes, when BMI and age were not adjusted, the RXGIN group significantly decreased PSA compared to placebo, which is considered a result of IPSS improvement [21]. The absence of significant changes in serum testosterone level indicates that RXGIN can safely treat male LUTS without affecting testosterone level.
For IIEF, total score, erectile function, orgasmic function, and intercourse satisfaction were significantly improved at 12 weeks, and sexual desire was significantly improved in the RXGIN group at 6 and 12 weeks compared to the placebo group. These results support the use of RXGIN as an alternative treatment for patients concerned about the side effects of existing drugs prescribed for erectile dysfunction. Another recent study has confirmed improvement of IIEF score by an herbal medicine consisting of Ginseng Radix Rubra in patients with erectile dysfunction [22].
When LUTS were divided into voiding and storage symptoms, this study showed a significant improvement in symptoms compared to placebo in the RXGIN group at 6 and 12 weeks, and the symptoms improved proportionally to the duration of administration (Fig. 1). In addition, it has been demonstrated through a previous multicenter clinical study that plant medicine can improve LUTS [23]. Moreover, another study demonstrated that ginseng can improve obstructive urinary symptoms by reducing mRNA expression of alpha adrenergic receptors in BPH mice [24].
However, in our study, failure to confirm a significant increase in Q max or decrease in PVR was a disappointing result. On the other hand, since the effect was seen in a relatively short period of 12 weeks, it is expected that a more significant effect could be obtained if the study were conducted for a longer duration in the future. There are a number of studies using phytotherapy that show a positive effect on the subjective IPSS, but no improvement in the objective uroflowmetry. However, further studies are needed to provide scientific evidence. [25,26]. Limitations of this study are that the duration of treatment was short by 12 weeks, the prostate size was not measured and urodynamic study was not performed in consideration of patient discomfort.
CONCLUSIONS
Ultimately, it was determined that RXGIN demonstrated an amelioration of symptoms in men with LUTS, as evidenced by significant improvement in total IPSS and total IIEF. In relation to side effects and sexual dysfunction of existing LUTS treatment drugs, red ginseng oil will be a pioneering substance that can safely provide therapeutic effects with limited side effects.
Acknowledgements
None.
Footnotes
Conflict of Interest: The authors have nothing to disclose.
Funding: This trial was supported by the Korea Medical Device Development Fund grant funded by the Korea government (the Ministry of Science and ICT, the Ministry of Trade, Industry and Energy, the Ministry of Health & Welfare, Republic of Korea, the Ministry of Food and Drug Safety) (Project Number: RS-2022-00140928).
- Conceptualization: SWK.
- Data curation: DS, JHK.
- Formal analysis: DS, GBK.
- Funding acquisition: WJB.
- Investigation: SWK.
- Methodology: DS, USH.
- Project administration: SWK.
- Resources: JHK, GBK.
- Supervision: SB, KHJ.
- Validation: SB.
- Visualization: DS.
- Writing – original draft: DS.
- Writing – review & editing: All authors.
Data Sharing Statement
The data that support the findings of this study are available from the corresponding author upon reasonable request.
Supplementary Materials
Supplementary materials can be found via https://doi.org/10.5534/wjmh.230172.
Baseline characteristics of patients
The CONSORT diagram. RXGIN: red ginseng oil.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Baseline characteristics of patients
The CONSORT diagram. RXGIN: red ginseng oil.
Data Availability Statement
The data that support the findings of this study are available from the corresponding author upon reasonable request.