NCT07135830

Brief Summary

This study aims to assess the potential recovery and strength effects of male handball players.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2025

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 22, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

August 25, 2025

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2025

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2025

Completed
Last Updated

August 22, 2025

Status Verified

August 1, 2025

Enrollment Period

16 days

First QC Date

August 7, 2025

Last Update Submit

August 15, 2025

Conditions

Keywords

ashwagandhastrengthrecoveryhandball

Outcome Measures

Primary Outcomes (5)

  • Rating of 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

    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

    Evaluations were conducted at three distinct time points: at baseline and at the 4th and 8th days after the baseline.

  • Knee Flexion

    Evaluations were conducted at three distinct time points: at baseline and at the 4th and 8th days after the baseline.

  • Handgrip

    Evaluations were conducted at three distinct time points: at baseline and at the 4th and 8th days after the baseline.

Secondary Outcomes (1)

  • Total Quality Recovery

    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

Study Arms (2)

Ashwaggandha supplementation

EXPERIMENTAL

Participants in this group took one capsule per day containing 600 mg of ashwagandha

Other: Handball training

Placebo

PLACEBO COMPARATOR

The placebo group consumed one capsule per day, identical in color and size to the ashwagandha capsules

Other: Handball training

Interventions

Athletes will perfrom their regular handball training

Ashwaggandha supplementationPlacebo

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Handball players competing nationally

You may not qualify if:

  • Injured athletes
  • Female athletes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Filipe Maia Principal Investigator

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 7, 2025

First Posted

August 22, 2025

Study Start

August 25, 2025

Primary Completion

September 10, 2025

Study Completion

September 30, 2025

Last Updated

August 22, 2025

Record last verified: 2025-08