Fibromyalgia SyndromeNCT07495943
Effects of 2-Aticyto Complex and D-Ribose on Pain and Clinical Course in Patients With Fibromyalgia
A study testing 2-Aticyto Complex and D-ribose Oral Supplement in people with Fibromyalgia Syndrome and Fibromyalgia, run by Haydarpasa Numune Training and Research Hospital at 5 sites in Turkey (Türkiye).
Trial summary
This multicenter, randomized, double-blind, placebo-controlled study will evaluate whether an oral supplement containing 2-Aticyto Complex and D-ribose (FibroThol), added to ongoing standard medical treatment, improves pain, symptoms, and clinical course in adults with fibromyalgia syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia Syndrome, Fibromyalgia
- What is being tested?
- 2-Aticyto Complex and D-ribose Oral Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 5 sitesTurkey (Türkiye)
- Study dates
- 4 Oct 2026to 4 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 65 years
- Diagnosis of fibromyalgia syndrome according to the 2016 ACR criteria
- Followed in a physical medicine and rehabilitation outpatient clinic for at least 1 year
- Receiving pregabalin and/or duloxetine treatment for at least 3 months
- Able to live independently in the community
- Literate and able to record symptoms and responses
- No cognitive dysfunction that would interfere with answering study questions
- Able and willing to provide informed consent
Who cannot join
- Rheumatologic disease
- Renal failure
- Hepatic failure
- Cardiovascular disease
- Hypoglycemia or diabetes mellitus
- Any neurologic disease (such as stroke, spinal cord injury, multiple sclerosis, or Parkinson's disease)
Show all 13Show fewer
- Known allergy or hypersensitivity to any active or excipient component of the study syrup
- Use of any other dietary supplement or nutritional support product during the study period
- Pregnancy or lactation
- Active malignancy
- Active infection
- Severe psychiatric disease that may interfere with study participation or assessment
- Refusal to participate or inability to provide informed consent
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Turkey (Türkiye)5 sites
University of Health Sciences, Haydarpasa Numune Training and Research Hospital, Department of Physical Medicine and Rehabilitation
Istanbul, Istanbul, 34662
Kubra Neslihan Kurt Oktay, MD, +905352916609, drneslihankurt@gmail.com
Arzu Erbilici, MD
University of Health Sciences, Basaksehir Cam and Sakura City Hospital, Department of Physical Medicine and Rehabilitation
Istanbul, 34480
Fatih Bagcıer, MD, +905442429042, bagcier_42@hotmail.com
University of Health Sciences, Sultan Abdulhamid Han Training and Research Hospital, Department of Physical Medicine and Rehabilitation
Istanbul, 34668
Mustafa Hüseyin Temel, MD, +905342714872, mhuseyintemel@gmail.com
Emre Ata, MD
Erenkoy Physical Therapy and Rehabilitation Hospital, Department of Physical Medicine and Rehabilitation
Istanbul, 34732
Sefa Kurt, MD, +905385159528, sefa.kurt@yahoo.com
University of Health Sciences, Fatih Sultan Mehmet Training and Research Hospital, Department of Physical Medicine and Rehabilitation
Istanbul, 34752
Ozge Gulsum Illeez, MD, +905326255684, ozgeilleez@gmail.com
About this study
Official title: Effects of 2-Aticyto Complex and D-Ribose on Pain, Symptoms, and Clinical Course in Patients With Fibromyalgia Syndrome
This multicenter, randomized, double-blind, placebo-controlled study will evaluate whether an oral supplement containing 2-Aticyto Complex and D-ribose (FibroThol), added to ongoing standard medical treatment, improves pain, symptoms, and clinical course in adults with fibromyalgia syndrome. Eligible participants are adults aged 18 to 65 years who have had fibromyalgia for at least 1 year and have been receiving pregabalin and/or duloxetine for at least 3 months. Participants will be randomly assigned to receive either FibroThol or placebo, administered as 15 mL three times daily for 4 weeks, while continuing their existing treatment. Follow-up assessments will be performed at baseline, week 2, and week 4 using patient-reported symptom and function measures. The study aims to determine whether this supportive supplement provides additional benefit compared with placebo in patients with persistent symptoms despite standard therapy.
Read the detailed description
Fibromyalgia syndrome is a chronic condition associated with widespread pain, fatigue, sleep disturbance, and reduced quality of life. Although standard pharmacologic treatments such as pregabalin and duloxetine are commonly used, symptom control may remain incomplete in many patients. This study was designed to investigate whether adding a supplement containing 2-Aticyto Complex and D-ribose to ongoing standard treatment can improve clinical outcomes in adults with fibromyalgia syndrome.
This is a multicenter, randomized, double-blind, placebo-controlled clinical study. Adults aged 18 to 65 years with fibromyalgia syndrome, diagnosed according to the ACR 2016 criteria, followed for at least 1 year, and receiving pregabalin and/or duloxetine treatment for at least 3 months will be eligible for participation. Major exclusion criteria include rheumatologic disease, renal failure, hepatic failure, cardiovascular disease, diabetes or hypoglycemia, neurologic disease, use of other supplements, allergy to study product ingredients, inability to complete study procedures, or refusal to participate.
After eligibility assessment and informed consent, participants will be randomly assigned to one of two study groups: placebo plus ongoing standard treatment or FibroThol plus ongoing standard treatment. The study treatment will be administered orally at a dose of 15 mL three times daily for 4 weeks. Study visits and assessments will be performed at baseline, week 2, and week 4.
Outcome measures will include pain intensity, neuropathic pain, fibromyalgia-related functional status, fatigue, sleep quality, anxiety, and depression, assessed using validated clinical scales. Safety will be evaluated through adverse event monitoring during the study period.
A total of 200 participants will be enrolled, with 100 participants assigned to the FibroThol group and 100 participants assigned to the placebo group. The primary objective is to determine whether the addition of 2-Aticyto Complex and D-ribose to standard treatment provides additional benefit in reducing pain and improving symptoms and overall clinical course in patients with fibromyalgia syndrome.
- Conditions
- Fibromyalgia Syndrome, Fibromyalgia
- Being tested
- 2-Aticyto Complex and D-ribose Oral Supplement, Placebo syrup
- Keywords
- Fibromyalgia, Fibromyalgia Syndrome, 2-Aticyto Complex, D-ribose, FibroThol, Dietary Supplement, Placebo-Controlled, Randomized, Double-Blind, Multicenter Study, Pregabalin, Duloxetine, Pain, Fatique, Sleep Quality, Depression, Anxiety, Quality of Life
- Medical subject headings
- Fibromyalgia, Pain, Sleep Initiation and Maintenance Disorders, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-Aticyto Complex and D-ribose Oral SupplementDietary supplement
An oral dietary supplement containing 2-Aticyto Complex and D-ribose (marketed as FibroThol). In this study, participants will receive 15 mL orally three times daily for 4 weeks in addition to ongoing standard treatment with pregabalin and/or duloxetine.
Placebo syrupOther
A matching oral placebo syrup without active study ingredients. In this study, participants will receive 15 mL orally three times daily for 4 weeks in addition to ongoing standard treatment with pregabalin and/or duloxetine. The placebo contains deionized water, glycerol, sodium alginate, xanthan gum, steviol glycosides, raspberry flavor, pineapple flavor, strawberry flavor, and mint flavor.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Plus Standard Treatment | Placebo comparator | Participants will receive matching placebo orally at 15 mL three times daily for 4 weeks, in addition to their ongoing standard medical treatment with pregabalin and/or duloxetine. Receives: Other: Placebo syrup |
| FibroThol Plus Standard Treatment | Experimental | Participants will receive FibroThol, an oral supplement containing 2-Aticyto Complex and D-ribose, at 15 mL three times daily for 4 weeks, in addition to their ongoing standard medical treatment with pregabalin and/or duloxetine. Receives: Dietary Supplement: 2-Aticyto Complex and D-ribose Oral Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Intensity Measured by Numeric Rating Scale (NRS)
Pain intensity will be assessed using the Numeric Rating Scale (NRS), an 11-point scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity. Change from baseline will be compared between groups.
Measured: Baseline, Week 2, and Week 4
Secondary outcomes (7)
Change in Neuropathic Pain Measured by DN4
Neuropathic pain symptoms will be assessed using the Douleur Neuropathique 4 (DN4) questionnaire, with a total score range of 0 to 10. Higher scores indicate more neuropathic pain features, and a score of 4 or more suggests neuropathic pain. Change from baseline will be compared between groups.
Measured: Baseline, Week 2, and Week 4
Change in Fibromyalgia Impact Questionnaire Score
Participation limitations will be assessed using the Fibromyalgia Participation Questionnaire, with transformed scale values ranging from 0 to 100. Higher scores indicate better participation and social functioning, so an increase from baseline reflects improvement.
Measured: Baseline, Week 2, and Week 4
Change in Fibromyalgia Participation Questionnaire Score
Fatigue severity will be assessed using the Fatigue Severity Scale, a 9-item scale with a total score range of 9 to 63. Higher scores indicate greater fatigue severity. Change from baseline will be compared between groups.
Measured: Baseline, Week 2, and Week 4
Change in Fatigue Severity Scale (FSS) Score
Participation limitations will be assessed using the Fibromyalgia Participation Questionnaire, with transformed scale values ranging from 0 to 100. Higher scores indicate better participation and social functioning, so an increase from baseline reflects improvement.
Measured: Baseline, Week 2, and Week 4
Change in Pittsburgh Sleep Quality Index (PSQI) Score
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index, with a global score range of 0 to 21. Higher scores indicate poorer sleep quality. Change from baseline will be compared between groups.
Measured: Baseline, Week 2, and Week 4
Change in Beck Depression Inventory Score
Depressive symptoms will be assessed using the Beck Depression Inventory, a 21-item scale with a total score range of 0 to 63. Higher scores indicate more severe depressive symptoms. Change from baseline will be compared between groups.
Measured: Baseline, Week 2, and Week 4
Change in Beck Anxiety Inventory Score
Anxiety symptoms will be assessed using the Beck Anxiety Inventory, a 21-item scale with a total score range of 0 to 63. Higher scores indicate more severe anxiety symptoms. Change from baseline will be compared between groups.
Measured: Baseline, Week 2, and Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start4 Oct 2026 (estimated)
- Primary completion4 May 2027 (estimated)
- Study completion4 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Fibromyalgia SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be assigned by block randomization in a 1:1 ratio to one of two parallel groups: placebo plus ongoing standard treatment or FibroThol plus ongoing standard treatment. Study treatment will be administered orally for 4 weeks in a multicenter setting.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haydarpasa Numune Training and Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Almediko Saglik Urunleri Turizm Gida Sanayi ve Ticaret Limited Sirketi
- Responsible party
- Principal investigator, Kubra Neslihan Kurt Oktay, Haydarpasa Numune Training and Research Hospital
- Investigators
- Kubra Neslihan Kurt Oktay, MD, Principal investigator, University of Health Sciences, Haydarpasa Numune Training and Research Hospital, Department of Physical Medicine and RehabilitationKubra Nesihan Kurt Oktay, MD, Study chair, University of Health Sciences, Haydarpasa Numune Training and Research Hospital, Department of Physical Medicine and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07495943
- Sponsor's protocol ID
- HNHAH-KAEK 2025/1
- Status last verified
- Sep 2026
- First submitted
- 23 Mar 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Aggregate results will be reported in publications and trial registry updates.
Publications
Teitelbaum J, Jandrain J, McGrew R. Treatment of Chronic Fatigue Syndrome and Fibromyalgia with D-Ribose- An Open-label, Multicenter Study. The Open Pain Journal. 2012;5:32-37.
Kerget F, Kerget B, Aksakal A, Kocak AO. Can 2-Aticyto Complex be an Effective Agent for Recovery of The Symptoms and Enhancing Laboratory Parameters in COVID-19 Patients? European Journal of Medical and Health Sciences. 2021;3(2):35-39. doi:10.24018/ejmed.2021.3.2.745.
Teitelbaum JE, Johnson C, St Cyr J. The use of D-ribose in chronic fatigue syndrome and fibromyalgia: a pilot study. J Altern Complement Med. 2006 Nov;12(9):857-62. doi: 10.1089/acm.2006.12.857.
PubMed 17109576
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 2-Aticyto Complex and D-Ribose on Pain, Symptoms, and Clinical Course in Patients With Fibromyalgia Syndrome
- ClinicalTrials.gov ID
- NCT07495943
- Acronym / sponsor ID
- HNHAH-KAEK 2025/1
- Conditions
- Fibromyalgia Syndrome, Fibromyalgia
- Keywords
- Fibromyalgia, Fibromyalgia Syndrome, 2-Aticyto Complex, D-ribose, FibroThol, Dietary Supplement, Placebo-Controlled, Randomized
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Haydarpasa Numune Training and Research HospitalUniversity, hospital or other
- Collaborators
- Almediko Saglik Urunleri Turizm Gida Sanayi ve Ticaret Limited Sirketi
- Study start
- 4 Oct 2026 (estimated)
- Primary completion
- 4 May 2027 (estimated)
- Study completion
- 4 May 2027 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicenter, randomized, double-blind, placebo-controlled study will evaluate whether an oral supplement containing 2-Aticyto Complex and D-ribose (FibroThol), added to ongoing standard medical treatment, improves pain, symptoms, and clinical course in adults with fibromyalgia syndrome. Eligible participants are adults aged 18 to 65 years who have had fibromyalgia for at least 1 year and have been receiving pregabalin and/or duloxetine for at least 3 months. Participants will be randomly assigned to receive either FibroThol or placebo, administered as 15 mL three times daily for 4 weeks, while continuing their existing treatment. Follow-up assessments will be performed at baseline, week 2, and week 4 using patient-reported symptom and function measures. The study aims to determine whether this supportive supplement provides additional benefit compared with placebo in patients with persistent symptoms despite standard therapy.
Detailed description
Fibromyalgia syndrome is a chronic condition associated with widespread pain, fatigue, sleep disturbance, and reduced quality of life. Although standard pharmacologic treatments such as pregabalin and duloxetine are commonly used, symptom control may remain incomplete in many patients. This study was designed to investigate whether adding a supplement containing 2-Aticyto Complex and D-ribose to ongoing standard treatment can improve clinical outcomes in adults with fibromyalgia syndrome.
This is a multicenter, randomized, double-blind, placebo-controlled clinical study. Adults aged 18 to 65 years with fibromyalgia syndrome, diagnosed according to the ACR 2016 criteria, followed for at least 1 year, and receiving pregabalin and/or duloxetine treatment for at least 3 months will be eligible for participation. Major exclusion criteria include rheumatologic disease, renal failure, hepatic failure, cardiovascular disease, diabetes or hypoglycemia, neurologic disease, use of other supplements, allergy to study product ingredients, inability to complete study procedures, or refusal to participate.
After eligibility assessment and informed consent, participants will be randomly assigned to one of two study groups: placebo plus ongoing standard treatment or FibroThol plus ongoing standard treatment. The study treatment will be administered orally at a dose of 15 mL three times daily for 4 weeks. Study visits and assessments will be performed at baseline, week 2, and week 4.
Outcome measures will include pain intensity, neuropathic pain, fibromyalgia-related functional status, fatigue, sleep quality, anxiety, and depression, assessed using validated clinical scales. Safety will be evaluated through adverse event monitoring during the study period.
A total of 200 participants will be enrolled, with 100 participants assigned to the FibroThol group and 100 participants assigned to the placebo group. The primary objective is to determine whether the addition of 2-Aticyto Complex and D-ribose to standard treatment provides additional benefit in reducing pain and improving symptoms and overall clinical course in patients with fibromyalgia syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants will be assigned by block randomization in a 1:1 ratio to one of two parallel groups: placebo plus ongoing standard treatment or FibroThol plus ongoing standard treatment. Study treatment will be administered orally for 4 weeks in a multicenter setting.
| Arm | Type | Receives |
|---|---|---|
| Placebo Plus Standard Treatment | Placebo comparator | Other: Placebo syrupParticipants will receive matching placebo orally at 15 mL three times daily for 4 weeks, in addition to their ongoing standard medical treatment with pregabalin and/or duloxetine. |
| FibroThol Plus Standard Treatment | Experimental | Dietary Supplement: 2-Aticyto Complex and D-ribose Oral SupplementParticipants will receive FibroThol, an oral supplement containing 2-Aticyto Complex and D-ribose, at 15 mL three times daily for 4 weeks, in addition to their ongoing standard medical treatment with pregabalin and/or duloxetine. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults aged 18 to 65 years
- Diagnosis of fibromyalgia syndrome according to the 2016 ACR criteria
- Followed in a physical medicine and rehabilitation outpatient clinic for at least 1 year
- Receiving pregabalin and/or duloxetine treatment for at least 3 months
- Able to live independently in the community
Key exclusion criteria (13 listed)
- Rheumatologic disease
- Renal failure
- Hepatic failure
- Cardiovascular disease
- Hypoglycemia or diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2-Aticyto Complex and D-ribose Oral SupplementAn oral dietary supplement containing 2-Aticyto Complex and D-ribose (marketed as FibroThol). In this study, participants will receive 15 mL orally three times daily for 4 weeks in addition to ongoing standard treatment with pregabalin and/or duloxetine. | Dietary supplement | FibroThol Plus Standard Treatment |
| Placebo syrupA matching oral placebo syrup without active study ingredients. In this study, participants will receive 15 mL orally three times daily for 4 weeks in addition to ongoing standard treatment with pregabalin and/or duloxetine. The placebo contains deionized water, glycerol, sodium alginate, xanthan gum, steviol glycosides, raspberry flavor, pineapple flavor, strawberry flavor, and mint flavor. | Other | Placebo Plus Standard Treatment |
Primary outcome
Change in Pain Intensity Measured by Numeric Rating Scale (NRS)
Time frame: Baseline, Week 2, and Week 4
Pain intensity will be assessed using the Numeric Rating Scale (NRS), an 11-point scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher scores indicate greater pain intensity. Change from baseline will be compared between groups.
7 secondary outcomes
Change in Neuropathic Pain Measured by DN4
Time frame: Baseline, Week 2, and Week 4
Change in Fibromyalgia Impact Questionnaire Score
Time frame: Baseline, Week 2, and Week 4
Change in Fibromyalgia Participation Questionnaire Score
Time frame: Baseline, Week 2, and Week 4
Change in Fatigue Severity Scale (FSS) Score
Time frame: Baseline, Week 2, and Week 4
Change in Pittsburgh Sleep Quality Index (PSQI) Score
Time frame: Baseline, Week 2, and Week 4
Change in Beck Depression Inventory Score
Time frame: Baseline, Week 2, and Week 4
Change in Beck Anxiety Inventory Score
Time frame: Baseline, Week 2, and Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- BackgroundTeitelbaum J, Jandrain J, McGrew R. Treatment of Chronic Fatigue Syndrome and Fibromyalgia with D-Ribose- An Open-label, Multicenter Study. The Open Pain Journal. 2012;5:32-37.
- BackgroundKerget F, Kerget B, Aksakal A, Kocak AO. Can 2-Aticyto Complex be an Effective Agent for Recovery of The Symptoms and Enhancing Laboratory Parameters in COVID-19 Patients? European Journal of Medical and Health Sciences. 2021;3(2):35-39. doi:10.24018/ejmed.2021.3.2.745.
- Background: PubMed 17109576Teitelbaum JE, Johnson C, St Cyr J. The use of D-ribose in chronic fatigue syndrome and fibromyalgia: a pilot study. J Altern Complement Med. 2006 Nov;12(9):857-62. doi: 10.1089/acm.2006.12.857.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Aggregate results will be reported in publications and trial registry updates.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kubra Neslihan Kurt Oktay, MD principal investigator
University of Health Sciences, Haydarpasa Numune Training and Research Hospital, Department of Physical Medicine and Rehabilitation
Kubra Nesihan Kurt Oktay, MD study chair
University of Health Sciences, Haydarpasa Numune Training and Research Hospital, Department of Physical Medicine and Rehabilitation
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2-Aticyto Complex and D-ribose Oral Supplement in people with Fibromyalgia Syndrome and Fibromyalgia, run by Haydarpasa Numune Training and Research Hospital at 5 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kubra Neslihan Kurt Oktay, MD (+905352916609, drneslihankurt@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity Measured by Numeric Rating Scale (NRS) (time frame: Baseline, Week 2, and Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07495943, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.