Ashwagandha for Muscle Damage

Overseen By Philip Chilibeck

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Saskatchewan

Disqualifiers: Pregnant, Breastfeeding, Exercise-affected conditions, others

Compensation: Varies

Number of Visits: 4

Duration: 10 days

20 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Ashwagandha for muscle damage?

Research shows that Ashwagandha can increase muscle strength and activity, as well as help muscle cells grow and repair. It has been found to improve muscle function and reduce muscle damage, making it potentially effective for muscle health. ^{1 2 3 4 5}

Is Ashwagandha generally safe for human use?

The provided research articles do not contain specific safety data on Ashwagandha. However, they highlight that while herbal medicines are often seen as low risk, they can have potential safety issues due to factors like contamination or interactions with other drugs. It's important to consult healthcare professionals for personalized advice. ^{6 7 8 9 10}

How does the drug Ashwagandha differ from other treatments for muscle damage?

Ashwagandha is unique because it contains withanolides, which help muscle cells develop and repair by activating specific pathways in the body. Unlike other treatments, it is a natural herb used in traditional medicine and may also improve muscle strength and recovery in people who exercise regularly. ^{2 3 5 11 12}

What is the purpose of this trial?

Ashwagandha is an herbal supplement that has a wide range of benefits related to exercise when supplemented for about 8-12 weeks. This study aims to investigate whether short-term Ashwagandha supplementation can enhance muscle recovery following exercise by measuring muscle strength recovery, swelling, and soreness in the biceps.

Eligibility Criteria

This trial is for men and women aged 18-35 who are generally healthy. It's not suitable for those with conditions affected by exercise, or individuals who are pregnant, breastfeeding, or have allergies to Dicalcium Phosphate, Cellulose, Vegetable magnesium stearate, or Silica.

Exclusion Criteria

Conditions that may be affected by exercise (determined by 'yes' answers to the 'Get Active Questionnaire')

Pregnant

Breastfeeding

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive Ashwagandha supplementation or placebo for 10 days

10 days

Daily supplementation

Exercise and Assessment

Participants perform muscle-damaging exercise and undergo assessments before and after exercise, and at 24, 48, and 72 hours post-exercise

4 days

Multiple assessments over 4 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

1-2 weeks

Treatment Details

Interventions

• Ashwagandha

Trial Overview The study tests if taking Ashwagandha supplements can help muscles recover after exercise. Participants will either receive Ashwagandha or a placebo and their muscle strength recovery, swelling, and soreness will be monitored.

Participant Groups

Group I: Ashwagandha Experimental Treatment 1 Intervention

600 mg/d Ashwagandha

Group II: Placebo Placebo Group 1 Intervention

600 mg/d placebo for 10 days

Who Is Running the Clinical Trial?

University of Saskatchewan

Lead Sponsor

Trials

261

Recruited

156,000+

Findings from Research

A systematic review of 57 studies from 2010 to 2015 identified various botanical extracts that can help improve skeletal muscle health, particularly in older adults.

The review categorized the benefits of these extracts into five key areas: reducing inflammation, preventing muscle damage, combating fatigue, preventing muscle atrophy, and promoting muscle regeneration and differentiation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review on the Effects of Botanicals on Skeletal Muscle Health in Order to Prevent Sarcopenia. Rondanelli, M., Miccono, A., Peroni, G., et al.[2020]

In a study involving 18 healthy volunteers, ashwagandha (WS) was well-tolerated at escalating doses over 30 days, with only one participant experiencing mild adverse effects, indicating its safety for use.

The study showed significant improvements in muscle strength and a trend towards reduced body fat percentage, suggesting that ashwagandha may enhance physical performance and overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploratory study to evaluate tolerability, safety, and activity of Ashwagandha (Withania somnifera) in healthy volunteers. Raut, AA., Rege, NN., Tadvi, FM., et al.[2021]

Herbal medicinal products (HMPs) are increasingly recognized for their potential risks, including toxicity, contamination, and interactions with other drugs, despite being perceived as low risk by the public.

Regulatory safety assessments for HMPs face challenges due to under-reporting of adverse reactions and a lack of comprehensive toxicity data, but new methods like predictive toxicology and poison control data can enhance safety evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of herbal medicinal products: challenges, and opportunities to increase the knowledge base for safety assessment. Jordan, SA., Cunningham, DG., Marles, RJ.[2022]

A study analyzing 489 kratom-related adverse drug reactions (ADRs) reported to the FDA from 2004 to 2021 found that kratom use is associated with significant safety concerns, including a 63-fold higher than expected rate of accidental deaths.

The analysis revealed strong signals for addiction and withdrawal symptoms, as well as a notable number of reports related to toxicity and seizures, indicating that while kratom is popular for treating pain and anxiety, it poses potential health risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of adverse drug reactions and outcomes attributed to kratom in the US Food and Drug Administration Adverse Event Reporting System from January 2004 through September 2021. Li, X., Ndungu, P., Taneja, SB., et al.[2023]

The study analyzed adverse event reports related to herbal supplements from two databases, FAERS and CVAR, revealing that herbal supplements accounted for 2.51% and 6.83% of total reports, respectively, indicating a significant presence of herbal-related safety concerns.

Common herbs associated with adverse events included Avena sativa (oats), Cannabis sativa (marijuana), and Hypericum perforatum (St John's Wort), highlighting the need for further investigation into the safety profiles of these supplements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying Herbal Adverse Events From Spontaneous Reporting Systems Using Taxonomic Name Resolution Approach. Sharma, V., Gelin, LFF., Sarkar, IN.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review on the Effects of Botanicals on Skeletal Muscle Health in Order to Prevent Sarcopenia. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Exploratory study to evaluate tolerability, safety, and activity of Ashwagandha (Withania somnifera) in healthy volunteers. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Ashwagandha Withanolides on Muscle Cell Differentiation. [2022]

4. Japan pubmed.ncbi.nlm.nih.gov

Effects of Ashwagandha (roots of Withania somnifera) on neurodegenerative diseases. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Examining the effect of Withania somnifera supplementation on muscle strength and recovery: a randomized controlled trial. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Assessment of herbal medicinal products: challenges, and opportunities to increase the knowledge base for safety assessment. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

An evaluation of adverse drug reactions and outcomes attributed to kratom in the US Food and Drug Administration Adverse Event Reporting System from January 2004 through September 2021. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Identifying Herbal Adverse Events From Spontaneous Reporting Systems Using Taxonomic Name Resolution Approach. [2020]

9. England pubmed.ncbi.nlm.nih.gov

Adverse effects of herbal medicines: an overview of systematic reviews. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Adverse drug reactions in some African herbal medicine: literature review and stakeholders' interview. [2022]

11. Ireland pubmed.ncbi.nlm.nih.gov

Adaptogenic and cardioprotective action of ashwagandha in rats and frogs. [2019]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Herb-Induced Liver Injury by Ayurvedic Ashwagandha as Assessed for Causality by the Updated RUCAM: An Emerging Cause. [2023]