- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07135830
- Original Trial
Ashwagandha (Withania Somnifera) and Its Effects on Recovery Perceived and Muscle Strength in Male Handball Players
August 15, 2025 updated by: Filipe Silvano Pinto Maia, University of Maia
Ashwagandha (Withania Somnifera) and Its Effects on Recovery Perceived and Muscle Strength in Male Handball Players: a Randomized Controlled Trial
This study aims to assess the potential recovery and strength effects of male handball players.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Filipe Maia Principal Investigator
- Phone Number: +351 22 986 6000
- Email: fmaia.dcd@umaia.pt
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Handball players competing nationally
Exclusion Criteria:
- Injured athletes
- Female athletes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Ashwaggandha supplementation
Participants in this group took one capsule per day containing 600 mg of ashwagandha
|
Athletes will perfrom their regular handball training
|
|
Placebo Comparator: Placebo
The placebo group consumed one capsule per day, identical in color and size to the ashwagandha capsules
|
Athletes will perfrom their regular handball training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Rating of fatigue
Time Frame: Evaluations were conducted at three distinct time points: at baseline and at the 4th and 8th days after the baseline. Participants' levels of fatigue were measured using the Rating of Fatigue Scale, which includes 10 descriptors ranging from "not fatigue
|
Evaluations were conducted at three distinct time points: at baseline and at the 4th and 8th days after the baseline. Participants' levels of fatigue were measured using the Rating of Fatigue Scale, which includes 10 descriptors ranging from "not fatigue
|
|
Perceived soreness
Time Frame: Evaluations were conducted at three distinct time points: at baseline and at the 4th and 8th days after the baseline. Perceived muscle soreness was evaluated using a 7-point Likert scale, where 0 indicated no soreness and 6 represented severe pain that s
|
Evaluations were conducted at three distinct time points: at baseline and at the 4th and 8th days after the baseline. Perceived muscle soreness was evaluated using a 7-point Likert scale, where 0 indicated no soreness and 6 represented severe pain that s
|
|
Knee Extension
Time Frame: Evaluations were conducted at three distinct time points: at baseline and at the 4th and 8th days after the baseline.
|
Evaluations were conducted at three distinct time points: at baseline and at the 4th and 8th days after the baseline.
|
|
Knee Flexion
Time Frame: Evaluations were conducted at three distinct time points: at baseline and at the 4th and 8th days after the baseline.
|
Evaluations were conducted at three distinct time points: at baseline and at the 4th and 8th days after the baseline.
|
|
Handgrip
Time Frame: Evaluations were conducted at three distinct time points: at baseline and at the 4th and 8th days after the baseline.
|
Evaluations were conducted at three distinct time points: at baseline and at the 4th and 8th days after the baseline.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Total Quality Recovery
Time Frame: Evaluations were conducted at three distinct time points: at baseline and at the 4th and 8th days after the baseline.Perceived recovery was evaluated using the Total Quality Recovery (TQR) scale, which ranges from 6 to 20, with endpoints reflecting "very
|
Evaluations were conducted at three distinct time points: at baseline and at the 4th and 8th days after the baseline.Perceived recovery was evaluated using the Total Quality Recovery (TQR) scale, which ranges from 6 to 20, with endpoints reflecting "very
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 25, 2025
Primary Completion (Estimated)
September 10, 2025
Study Completion (Estimated)
September 30, 2025
Study Registration Dates
First Submitted
August 7, 2025
First Submitted That Met QC Criteria
August 15, 2025
First Posted (Actual)
August 22, 2025
Study Record Updates
Last Update Posted (Actual)
August 22, 2025
Last Update Submitted That Met QC Criteria
August 15, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- JFF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.