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Study protocol
Jakyakgamcho-tang in the Relief of Delayed-Onset Muscle Soreness in Healthy Adults: study protocol for a randomized, double-blind, placebo-controlled, cross-over design clinical trial
Jun-Hwan Lee
Korea Institute of Oriental Medicine
Corresponding Author
ORCiD: https://orcid.org/0000-0001-5730-6869
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Trials.
Background
Muscle soreness after exercise, or so-called delayed onset muscle soreness (DOMS), may cause significant changes to 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 was to evaluate the effect of JGT for reducing pain and improving muscle damage after exercise.
Methods
This study is a randomized, double-blind, placebo-controlled, cross-over 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 hour 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.
Discussion
This 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.
Keywords
Delayed onset muscle soreness, herbal medicine, Jakyakgamcho-tang, Peony licorice decoction, Shakuyakukanzoto, Shaoyaogancao-tang
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Peer Review Timeline
CURRENT STATUS: Published
Published
On 21 Feb, 2020
No community comments so far
Editorial decision: Accept
On 29 Jan, 2020
Review #1 received
Received 08 Jan, 2020
Reviewers invited
Invitations sent on 06 Jan, 2020
Reviewer #1 agreed
On 06 Jan, 2020
Editor assigned
On 03 Jan, 2020
Submission checks complete
On 02 Jan, 2020
Version 1
Posted 29 May, 2019
No comments provided
Editorial decision: Minor revision
On 13 Dec, 2019
Review #3 received
Received 11 Dec, 2019
Review #2 received
Received 11 Dec, 2019
Reviewer #3 agreed
On 26 Nov, 2019
Reviewer #2 agreed
On 08 Oct, 2019
Review #1 received
Received 21 Sep, 2019
Reviewer #1 agreed
On 10 Sep, 2019
Reviewers invited
Invitations sent on 09 Sep, 2019
Editor assigned
On 17 Jul, 2019
Submission checks complete
On 28 May, 2019
First submitted
On 17 May, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Translational Medicine
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This preprint is under consideration at Trials. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Jakyakgamcho-tang in the Relief of Delayed-Onset Muscle Soreness in Healthy Adults: study protocol for a randomized, double-blind, placebo-controlled, cross-over design clinical trial
Jun-Hwan Lee
Korea Institute of Oriental Medicine
Corresponding Author
ORCiD: https://orcid.org/0000-0001-5730-6869
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
Published
On 21 Feb, 2020
No community comments so far
Editorial decision: Accept
On 29 Jan, 2020
Review #1 received
Received 08 Jan, 2020
Reviewers invited
Invitations sent on 06 Jan, 2020
Reviewer #1 agreed
On 06 Jan, 2020
Editor assigned
On 03 Jan, 2020
Submission checks complete
On 02 Jan, 2020
Version 1
Posted 29 May, 2019
No comments provided
Editorial decision: Minor revision
On 13 Dec, 2019
Review #3 received
Received 11 Dec, 2019
Review #2 received
Received 11 Dec, 2019
Reviewer #3 agreed
On 26 Nov, 2019
Reviewer #2 agreed
On 08 Oct, 2019
Review #1 received
Received 21 Sep, 2019
Reviewer #1 agreed
On 10 Sep, 2019
Reviewers invited
Invitations sent on 09 Sep, 2019
Editor assigned
On 17 Jul, 2019
Submission checks complete
On 28 May, 2019
First submitted
On 17 May, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Translational Medicine
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published version at Trials.
Background
Muscle soreness after exercise, or so-called delayed onset muscle soreness (DOMS), may cause significant changes to 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 was to evaluate the effect of JGT for reducing pain and improving muscle damage after exercise.
Methods
This study is a randomized, double-blind, placebo-controlled, cross-over 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 hour 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.
Discussion
This 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.
Figure 1
Figure 2