Study of Red Ginseng Preparation HRG80 for Relieving Muscle Pain/Soreness and Supporting the Neuromuscular Performance of Elite Weightlifters in Intense Resistance Exercise: An Open-Label, Randomized, Crossover Trial

Research Article

Phys Med Rehabil Int. 2022; 9(3): 1207.

Study of Red Ginseng Preparation HRG80 for Relieving Muscle Pain/Soreness and Supporting the Neuromuscular Performance of Elite Weightlifters in Intense Resistance Exercise: An Open-Label, Randomized, Crossover Trial

Hovhannisyan AS¹, Mosinyan DN², Hayrumyan SA² and Panossian AG³*

1Anti-Doping Agency of the Republic of Armenia, Armenia

2Kardiomed Family Medical Centre, Armenia

3Phytomed AB, Sweden

4EuropharmaUSA Inc., Green Bay, Wisconsin, USA

*Corresponding author: Panossian AG, Phytomed AB, 58344 Västervick, Sweden

Received: October 08, 2022; Accepted: November 08, 2022; Published: November 15, 2022

Abstract

This study aimed to assess the efficacy of new Panax ginseng C.A.Mey preparation of increased bioavailability in fatigue assessed as relief of muscle soreness and improving the neuromuscular performance of healthy subjects following a bout of intense resistance exercise. The effects of the hydroponically cultivated red ginseng root powder HRG80TM (RG) γ-Cyclodextrin -based chewable tablets and cyclodextrin-free RG capsules were compared in an openlabel, randomized, crossover trial on 20 elite weightlifters. The RG treatments for 10 days have a statistically significant effect on the relief of the muscle’s soreness compared to the control. No statistically significant difference was observed in the effects of two capsules vs. one tablet suggesting that γ-Cyclodextrin based chewable tablets of red ginseng preparation HRG80 are almost 4-fold active of cyclodextrin-free HRG80 capsules.

Furthermore, the effect of tablets vs. control was significant on the 5th day of the treatment, while the effect of capsules vs. control was observed three days later - on the 8th day. However, in push-ups on the uneven bars (PUB) test of neuromuscular performance, the capsule intake results in increased physical performance compared to tablets or control with maximal effect on the 7th day of treatment. The results of this study provide evidence for the efficacy of γ-cyclodextrin-based chewable tablets containing 100 mg of red ginseng HRG80TM for relief of muscle soreness and supporting the neuromuscular performance of healthy subjects in intense resistance exercise.

Keywords: Red Ginseng; Fatigue; Muscle Pain; Athletes; γ-Cyclodextrin

Introduction

Panax ginseng C.A.Mey. is likely one of the most widely used botanicals in the world [1,2]. This adaptogenic plant [2-8] is approved in Europe and other countries as an herbal medicinal product to enhance cognitive functions and physical capacities in weakness, exhaustion, tiredness, loss of concentration, and during convalescence [9-10].

The number of recent publications indicates on beneficial effects of Korean red ginseng in healthy subjects [11-13], increasing their psychomotor and physical performance [11] and cognitive functions [14-15] in stress. Thus, hydroponically cultivated red ginseng root powder HRG80TM (RG) effectively prevents and mitigates the stressinduced deterioration of cognitive functions in healthy subjects [14] and elderly patients with mild cognitive disorders [15]. In this study, we aimed to assess the efficacy of RG in relieving muscle soreness and improving the neuromuscular performance of elite weightlifters.

Major active constituents of RG, ginsenosides Rg5 and Rk1comprising about 1.9% and 1.0% of RG [16], exhibit pleiotropic pharmacological activity [16-19]; however, their content in the blood circulation system is low due to poor solubility in water [20-22]. A recent study suggests that Gamma-Cyclodextrin (GCD) can increase the clinical efficacy of RG due to the enhanced solubility of the main active ingredients, ginsenosides Rg5 and Rk1[23]. In this study, we compared the effectiveness of RG capsules with chewable tablets containing the γ-cyclodextrin incorporated RG.

The primary aim of this study was to compare the effects of the GCD-based complex of RG chewable tablets with cyclodextrin-free RG capsules on measures of perception and physical performance following an acute bout of intense resistance exercise.

Materials and Methods

Participants Eligibility

A study of the efficacy of RG preparation in healthy athletes was conducted in National Team Training Center (Abovyan City, Armenia), with the approval of the Kardiomed Family Medical Centre Ethics Committee (approval date: Jul 22, 2022). It is an extension of a comparative study of dissolution and pharmacokinetics of ginsenosides released from cyclodextrin-based chewable tablets in healthy human subjects (ClinicalTrials.gov ID: NCT04932265. The study was performed per the Declaration of Helsinki (52nd WMA General Assembly, Edinburgh, Scotland, October 2000). All participants provided written informed consent (Supplement 2, page 1) to participate in the study before being screened.

Study-Population Selection

Twenty 18.6 ± 4.7 years old professional weightlifting athletes (Supplemental Table S1 in Supplement 1) were assessed for eligibility to participate in the study from July to September 2022. Fourteen males and six females were enrolled in the study and included in the Intention-To-Treat (ITT) analysis Supplemental Tables S2 -S4 in Supplement 1. The athletes were part of the Armenian National Weightlifting team competing at the Word and European championships 2020-2021.

Inclusion Criteria

The athletes were experiencing stress, fatigue, and muscle soreness after two hours intensive physical exercise but were otherwise healthy. The inclusion criteria were as follows: 16-35 years old healthy athletes (males and females of any race and ethnicity) who admitted the presence of daily strength training and the absence of competition during the study period, can understand and provide signed informed consent (Supplement 2, page 1), and were able to participate in a 6-week study.

Exclusion Criteria

The exclusion criteria were as follows: taking over-the-counter medications or dietary supplements that may have potential effects on pain, the presence of muscle trauma or injury, and any other condition that precluded participation according to the investigator’s judgment.

Investigational Products

Commercially available Dietary Supplements of Red Ginseng Energy Chewable Tablets (Lot 2241-0201, Exp. date Jan 2023) containing 100 mg of red ginseng preparation HRG80 and 400 mg GCD and Red Ginseng Energy Capsules (Lot 201049, Exp. date Jan 2023), containing 200 mg of red ginseng preparation HRG80 were provided by Europharma U.S.A. (Green Bay, WI, USA). Their chemical characterization was described in detail in our recent publications [14,15,23].

Doses and Treatment Regimens

Participants received either two Red Ginseng Energy Capsules containing 200 mg of red ginseng preparation HRG80 (daily dose 400 mg HRG80), or one Red Ginseng Energy Chewable Tablet containing 100 mg of red ginseng preparation HRG80 (daily dose 100 mg HRG80) once a day in the morning after breakfast for 10 consecutive days.

Evaluation of Compliance

Participants were questioned about their overall compliance with the study protocol during the study, and the study personnel counted the remaining capsules. Compliance was monitored by the doctor of the study, who checked the participants’ records that were attached to the case report form (CRF, Supplement 2). The study monitor checked overall compliance with the study protocol upon their visits, and the remaining capsules were counted at the end of the study.

Study Design and Procedure

It was an open-label, randomized crossover trial where the same subject took both preparations and was used as a control (no treatment), (Figure 1). On day one, all participants started phase A of the study for ten days, which provided outcomes used as the negative control for treatments. After three days of recovery without physical exercises, all participants were randomly separated into two treatment groups (10:10) allocated to interventions A and B to enter Phase B of the study for ten days. After one week of washout, the athletes entered Phase C of the study, where the subjects were crossover switched from intervention A to B and vice versa – from B to A.