Grape drink shows promise for fibromyalgia pain relief
NCT ID NCT07403929
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 45 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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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
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20 to 40 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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.
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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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İstanbul University-Cerrahpaşa Hospital
RECRUITINGIstanbul, Istanbul, 34098, Turkey (Türkiye)
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Zapping the vagus nerve: a new hope for fibromyalgia pain?
- Can a Video-Call stretching program ease fibromyalgia pain?
- Writing as medicine: can words soothe chronic pain?