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Grape drink shows promise for fibromyalgia pain relief

NCT ID NCT07403929

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This study looks at whether a traditional fermented grape drink called hardaliye can reduce pain and inflammation in women with fibromyalgia. About 45 women aged 20-40 will be split into three groups: one gets a personalized diet plus the drink, one gets only the diet, and one gets only the drink. The goal is to see if the drink improves antioxidant levels, lowers inflammation, and eases symptoms like pain, sleep problems, and mood issues over 8 weeks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 45 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 40 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Female, 20-40 years * BMI 25.0-29.9 kg/m² * FM per 2016 ACR criteria; abdominal pain/cramp per SSS sub-item * MEDAS ≤5 at screening. * Willing to maintain habitual activity and comply with assigned intervention; able to provide informed consent. Exclusion Criteria: * Age \<20 or \>40 * BMI ≤24.99 or ≥30.0 kg/m² * Professional athletes; night-shift workers * Food allergies; acute infection; antibiotic use within past month or during intervention. * Use (past 3 months) of dietary supplements; recent weight-loss or special diets (e.g., ketogenic). * Pregnancy/lactation; menopause. * Major hepatic/renal/cardiac/immune disease; chronic GI diseases; diabetes; CNS disorders; cancer; thyroid disease; severe pulmonary disease. Inflammatory arthritis/autoimmune disease impacting weight; medications including corticosteroids, estrogens, analgesics/anti-inflammatories, anti-diabetic or lipid-lowering drugs. * Severe psychiatric illness/substance use; heavy alcohol/smoking. * High recent intake of grape juice/molasses; excess tea/coffee (≥7 cups/day). * Adherence \<80% to beverage or MNT during run-in/screening.

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Conditions

The condition(s) this trial relates to.

Chronic Pain fibromyalgia Inflammation Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • İstanbul University-Cerrahpaşa Hospital

    RECRUITING

    Istanbul, Istanbul, 34098, Turkey (Türkiye)

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