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Could ozone therapy ease fibromyalgia pain and fatigue?

NCT ID NCT07680621

Symptom relief Sponsor: Sakarya University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Last updated Jul 02, 2026

Summary

This study investigates whether major ozone autohemotherapy — a procedure where a small amount of blood is mixed with ozone and returned to the body — can improve pain, fatigue, sleep, and muscle health in women with fibromyalgia. Sixty participants will receive either exercise alone or exercise plus ozone therapy twice a week for five weeks. Researchers will measure changes in symptoms and muscle function over three months to see if the treatment offers lasting benefits.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ozone gas
What this could lead to
If it works, this could offer a new option to reduce pain, fatigue, and sleep problems in people with fibromyalgia.
What could go wrong
This is a small, early-stage study with only 60 participants. Ozone therapy may not prove effective, and its long-term safety is not yet established.

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 60 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Mar 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

18 to 65 years

Sex

Anyone

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 patients aged 18-65 years * Diagnosis of fibromyalgia syndrome according to the 2016 ACR criteria: * Symptoms present at a similar level for at least 3 months * Widespread Pain Index (WPI) ≥ 7 and Symptom Severity Scale (SSS) ≥ 5 * WPI 4-6 and SSS ≥ 9 * Not currently receiving medical treatment for fibromyalgia (except NSAIDs) Exclusion Criteria: * Current or previous pharmacological treatment specifically for fibromyalgia * Pregnancy or breastfeeding * History of active or previous malignancy * History of systemic inflammatory diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, psoriatic arthritis, dermatomyositis, familial Mediterranean fever) * Endocrine disorders (e.g., hypothyroidism, Cushing's syndrome, adrenal insufficiency) * Anemia * Chronic renal failure * Chronic liver failure * Chronic obstructive pulmonary disease (COPD) * Known severe cardiovascular disease * Body mass index (BMI) \> 30 kg/m² * Glucose-6-phosphate dehydrogenase (G6PD) deficiency

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Conditions

The condition(s) this trial relates to.

fibromyalgia

As listed by the trial registrant

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

Fibromyalgia

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

  • Sakarya Training and Research Hospital

    Sakarya, Turkey (Türkiye)

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