An interventional study of 2-Aticyto Complex and D-ribose Oral Supplement and Placebo syrup in Fibromyalgia Syndrome and Fibromyalgia, sponsored by Haydarpasa Numune Training and Research Hospital. Not yet recruiting at 5 sites in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by Haydarpasa Numune Training and Research Hospital · Not applicable, Interventional, and Treatment
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.
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.
1,243 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.
This study's planned enrollment of 200 is above the median of 60 across 937 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →Haydarpasa Numune Training and Research Hospital is the lead sponsor of 33 studies on the registry; 7 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Placebo syrup
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.
Dietary Supplement: 2-Aticyto Complex and D-ribose Oral 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.
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.
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.
Time frame: Baseline, Week 2, and Week 4
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Week 2, and Week 4
Plan to share: No — Individual participant data will not be shared. Aggregate results will be reported in publications and trial registry updates.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Haydarpasa Numune Training and Research Hospital