Abstract
BackgroundMuscle soreness after exercise, called delayed-onset muscle soreness (DOMS), may cause significant changes in muscle function and may increase the risk of sports injuries. Therefore, various therapeutic strategies have been studied to help recovery after exercise. Jakyakgamcho-tang (JGT) is a widely prescribed herbal medicine to treat muscle pain and cramps in traditional Eastern medicine. The aim of this study is to evaluate the effect of JGT for reducing pain and improving muscle damage after exercise.MethodsThis study is a randomized, double-blind, placebo-controlled, crossover design clinical trial. A total of 30 healthy male adults will be recruited. Subjects who voluntarily wish to participate in this study will be hospitalized for 4 days. On the first day, the subjects will perform a standardized treadmill exercise for 1 h to induce DOMS. After the exercise, the subjects will take either JGT or a placebo for 3 days. After a more than 1 week wash-out period, the subjects will repeat the same process with the other drug. Pain intensity, calf circumference, and pain threshold will be measured as outcome measures. Blood tests and blood pressure will be measured as safety assessments. In addition, blood tests for muscle damage and inflammation markers, such as creatine kinase, interleukin-6, and C-reactive protein, will be analyzed.DiscussionThis will be the first trial to assess the effect of JGT on exercise-induced muscle soreness. Our findings will provide valuable data to determine the clinical effects of JGT on DOMS.Trial registrationClinical Research Information Sevice, KCT0003457. Registered on 29 January 2019.
Highlights
Muscle soreness after exercise, called delayed-onset muscle soreness (DOMS), may cause significant changes in muscle function and may increase the risk of sports injuries
The aim of this study is to evaluate the effect of JGT on pain reduction and improvements in muscle damage after exercise
If suspected unexpected serious adverse reactions occur, they will be reported to the Ministry of Food and Drug Safety according to the relevant regulations. This is a protocol for a randomized, double-blind, placebocontrolled, crossover-designed clinical trial to study the efficacy and safety of the herbal medicine JGT in the relief of DOMS in healthy male adults
Summary
Muscle soreness after exercise, called delayed-onset muscle soreness (DOMS), may cause significant changes in muscle function and may increase the risk of sports injuries. The aim of this study is to evaluate the effect of JGT for reducing pain and improving muscle damage after exercise. DOMS symptoms, such as pain, discomfort, muscle tenderness, or loss of range of motion, usually occur 12–48 h after exercise and mend within 7 days. Symptoms disappear over time, eccentric activity may cause significant changes to muscle function and may increase the risk of sports injuries [2]. Various supplements with anti-inflammatory and antioxidant effects have been studied to help recovery after exercise [12,13,14]. There has been increasing interest in herbal medicines to treat DOMS because of their holistic approach and minimal side effects [15]
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