Dry EyeADETNCT07185854

Medical vs Acupuncture for Dry Eye

A study testing Artificial tears and Traditional Chinese Medicine Acupuncture in people with Dry Eye and Acupuncture, run by Nadide Koca at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Dry Eye, Acupuncture
What is being tested?: Artificial tears and Traditional Chinese Medicine Acupuncture
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 15 Jan 2024to 1 Aug 2025
Phase: Interventional
Are there results?: None posted in the registry

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

Age between 18 and 65 years
Diagnosis of moderate dry eye disease according to TFOS DEWS II criteria
Anesthetized Schirmer test result between 5-10 mm
Tear break-up time (tBUT) between 6-10 seconds
Ocular Surface Disease Index (OSDI) score ≥ 13
Symptom duration of at least 3 months
Signed informed consent form

Who cannot join

Sjögren's syndrome, active blepharitis, or meibomian gland dysfunction
Systemic rheumatologic, autoimmune, or metabolic disease (e.g., diabetes)
Use of systemic or topical treatment for dry eye within the last 6 months
Previous ocular surgery
Contact lens use
Pregnancy or lactation
History of neurological or psychiatric disorders

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Ankara Training and Research Hospital Ankara, Altindag, Turkey, 06230
Ankara, Altindag, 06230

Other trials in Turkey (Türkiye)

About this study

Official title: Acupuncture Combined With Artificial Tears Compared With Artificial Tears Alone in Moderate Dry Eye: A Randomized Controlled Trial

This randomized clinical trial was designed to evaluate the effectiveness of acupuncture combined with artificial tears compared to artificial tears alone in patients with moderate dry eye disease. A total of 90 participants were enrolled at the University of Health Sciences, Ankara Training and Research Hospital. Patients were randomly assigned to receive either artificial tears only or artificial tears with acupuncture. Acupuncture was performed twice weekly for ten sessions by a certified specialist.

Assessments were conducted at baseline, after treatment, and at one-month follow-up using the Ocular Surface Disease Index (OSDI), Schirmer test, and tear break-up time (tBUT). The primary outcome measure was the change in OSDI score, while secondary outcomes included Schirmer test values and tBUT.

Read the detailed description

Dry eye disease (DED) is a chronic ocular surface disorder characterized by instability of the tear film, ocular discomfort, and visual disturbance. It significantly impairs quality of life, limiting daily activities such as reading, driving, and computer use. Standard treatments, including artificial tears and anti-inflammatory agents, often provide only partial or temporary relief and may not adequately address the underlying inflammatory mechanisms. As a complementary approach, acupuncture has been suggested to improve lacrimal gland function, enhance tear secretion, and reduce ocular inflammation, yet comparative evidence in moderate DED remains limited.

The aim of this study was to evaluate the short-term efficacy of acupuncture combined with artificial tears compared to artificial tears alone in patients with moderate DED. This prospective, randomized, controlled, parallel-group trial was conducted at the University of Health Sciences, Ankara Training and Research Hospital. Ninety adults aged 18-65 years, diagnosed with moderate DED according to TFOS DEWS II criteria (Schirmer 5-10 mm and tear break-up time 6-10 seconds), were enrolled between January 2024 and May 2025. Participants were randomly allocated to two groups: Group 1 received artificial tears only, while Group 2 received artificial tears plus acupuncture.

Conditions: Dry Eye, Acupuncture
Being tested: Artificial tears, Traditional Chinese Medicine Acupuncture
Keywords: Dry eye, Keratoconjunctivitis sicca, Acupuncture, Artificial tears, Ocular Surface Disease Index (OSDI), Schirmer test, Tear break-up time (tBUT), Complementary therapy
Medical subject headings: Dry Eye Syndromes, Keratoconjunctivitis Sicca

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Artificial tearsDrug
Also called Lubricating Eye Drops, Artificial Tear Drops, Sodium Hyaluronate Eye Drops
Topical artificial tears were administered as standard therapy for moderate dry eye disease.
Traditional Chinese Medicine AcupunctureOther
Also called Needle Acupuncture, Manual Acupuncture
Acupuncture therapy performed by a certified specialist using sterile disposable needles at predefined local and systemic acupoints (BL2, ST1, GB1, SJ23, Ex-HN5, LI4, ST36, SP6, LIV3, GB37, GB40, Ex-HN3, Du23, BL64). Sessions were delivered twice weekly for a total of 10 sessions, each lasting 20 minutes. Deqi sensation was obtained by manual stimulation. No additional systemic or topical treatments were provided to participants in this arm.

Study groups in NCT07185854
Study group	Role	What they receive
Artificial Tears Only	Active comparator	Participants received topical artificial tears (sodium hyaluronate/CMC-based eye drops) according to standard treatment protocol. No additional intervention was given. Receives: Drug: Artificial tears
Experimental: Artificial Tears + Acupuncture	Experimental	Participants received artificial tears plus acupuncture therapy, administered by a certified specialist, twice weekly for 10 sessions. Each session lasted 20 minutes. Receives: Drug: Artificial tears; Other: Traditional Chinese Medicine Acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Ocular Surface Disease Index (OSDI) Score
The Ocular Surface Disease Index (OSDI) is a 12-item questionnaire used to assess the severity of dry eye symptoms and their impact on visual function. Scores range from 0 to 100, with higher scores indicating more severe disease. The primary outcome is the change in OSDI score from baseline to post-treatment and 1-month follow-up.
Measured: Baseline (Day 1); End of Treatment (Week 5, after 10 sessions); 1-Month Follow-up (Week 9)

Secondary outcomes (2)

Change in Schirmer Test Values
The Schirmer test measures tear production using a standardized filter paper strip placed in the lower eyelid for 5 minutes. Values are recorded in millimeters of wetting. Lower scores indicate reduced tear secretion. The outcome is the change in tear production over time.
Measured: Baseline (Day 1); End of Treatment (Week 5, after 10 sessions); 1-Month Follow-up (Week 9)
Change in Tear Break-Up Time (tBUT)
Tear break-up time (tBUT) is assessed after instillation of fluorescein dye. The interval between the last blink and the first appearance of a dry spot on the corneal surface is measured in seconds. Shorter times indicate instability of the tear film. The outcome is the change in tBUT values across time points.
Measured: Baseline (Day 1); End of Treatment (Week 5, after 10 sessions); 1-Month Follow-up (Week 9)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jan 20241 Aug 2025

First posted22 Sep 2025
Study start15 Jan 2024
Primary completion30 Jun 2025
Study completion1 Aug 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (20)Papers the sponsor has linked to this study.
Other trials for Dry EyeStudies 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: Two-arm parallel group randomized controlled trial comparing artificial tears alone with artificial tears plus acupuncture in patients with moderate dry eye disease.
Masking: None (open label)
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07185854
Sponsor's protocol ID: AnkaraTRH-FTR-NK-09
Other IDs: 2023/11-090224
Acronym: ADET
Status last verified: Sep 2025
First submitted: 8 Sep 2025
Last updated: 22 Sep 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Individual participant data (IPD) will not be shared because the trial was conducted as a single-center interventional study and includes sensitive clinical information that cannot be sufficiently de-identified for open sharing. Aggregate results will be reported in peer-reviewed publications.

Publications

Duan H, Zhou Y, Ma B, Liu R, Yang T, Chu H, Huo Z, Qi H. Effect of Acupuncture Treatment on the Ocular Pain, Mental State and Ocular Surface Characteristics of Patients with Dry Eye Disease: A Non-Randomized Pilot Study. Clin Ophthalmol. 2024 Oct 3;18:2751-2764. doi: 10.2147/OPTH.S476573. eCollection 2024.
PubMed 39376907
Zhang X, Zhang B, Peng S, Zhang G, Ma J, Zhu W. Effectiveness of acupuncture at acupoint BL1 (Jingming) in comparison with artificial tears for moderate to severe dry eye disease: a randomized controlled trial. Trials. 2022 Jul 27;23(1):605. doi: 10.1186/s13063-022-06486-4.
PubMed 35897025
Wang Y, Peng J, Xiao L, Deng Y, Lu J, Zhou YS, Yang YJ, Peng QH. Effectiveness of acupuncture combined with artificial tears in managing dry eye syndrome: A systematic review and meta-analysis. Medicine (Baltimore). 2024 Jan 5;103(1):e36374. doi: 10.1097/MD.0000000000036374.
PubMed 38181299
Moon SY, Chung HS, Lee JH, Lee H, Tchah H, Kim JY. Effectiveness of cyclosporine nanoemulsion eye drops in patients with mild-to-moderate dry eyes: objective and subjective evaluation. BMC Ophthalmol. 2024 Sep 9;24(1):401. doi: 10.1186/s12886-024-03620-5.
PubMed 39251947
Bawazeer AM, Hodge WG. One-minute schirmer test with anesthesia. Cornea. 2003 May;22(4):285-7. doi: 10.1097/00003226-200305000-00001.
PubMed 12792467
Kuang H, Zhu X, Chen H, Tang H, Zhao H. The immunomodulatory mechanism of acupuncture treatment for ischemic stroke: research progress, prospects, and future direction. Front Immunol. 2024 May 2;15:1319863. doi: 10.3389/fimmu.2024.1319863. eCollection 2024.
PubMed 38756772
Oh JE, Kim SN. Anti-Inflammatory Effects of Acupuncture at ST36 Point: A Literature Review in Animal Studies. Front Immunol. 2022 Jan 12;12:813748. doi: 10.3389/fimmu.2021.813748. eCollection 2021.
PubMed 35095910
McCann P, Kruoch Z, Lopez S, Malli S, Qureshi R, Li T. Interventions for Dry Eye: An Overview of Systematic Reviews. JAMA Ophthalmol. 2024 Jan 1;142(1):58-74. doi: 10.1001/jamaophthalmol.2023.5751.
PubMed 38127364
McMonnies CW. Why the symptoms and objective signs of dry eye disease may not correlate. J Optom. 2021 Jan-Mar;14(1):3-10. doi: 10.1016/j.optom.2020.10.002. Epub 2020 Nov 23.
PubMed 33243674
Villani E, Campagna G, Gentili V, Postorino EI, Genovese P, Palino P, Maini G, Carbucicchio A, Ferioli E, Nucci P, Rizzo R, Aragona P. Hydroxypropyl-Methylcellulose and GlicoPro(R) Eyedrops in the Treatment of Dry Eye Disease: In Vitro and Clinical Study. Ophthalmol Ther. 2025 Apr;14(4):787-803. doi: 10.1007/s40123-025-01101-6. Epub 2025 Mar 1.
PubMed 40024993
Cartes C, Aravena C, Monsalve A, Segovia C, Romero C, Quidel D, Cid F, Monsalve R, Navarro L, Araya D, Araneda D, Sepulveda M. Prevalence of Dry Eye Disease in Laser-Assisted In Situ Keratomileusis Candidates. Eye Contact Lens. 2024 Jul 1;50(7):305-310. doi: 10.1097/ICL.0000000000001095. Epub 2024 May 2.
PubMed 38918902
Chen A, Augello P, Asbell P, Ying GS; DREAM Research Group. The repeatability of tests for dry eye signs and symptoms in the dry eye assessment and management (DREAM) study. Cont Lens Anterior Eye. 2025 Apr;48(2):102322. doi: 10.1016/j.clae.2024.102322. Epub 2024 Oct 30.
PubMed 39477774
Qian L, Wei W. Identified risk factors for dry eye syndrome: A systematic review and meta-analysis. PLoS One. 2022 Aug 19;17(8):e0271267. doi: 10.1371/journal.pone.0271267. eCollection 2022.
PubMed 35984830
Kwon J, Moghtader A, Kang C, Bibak Bejandi Z, Shahjahan S, Alzein A, Djalilian AR. Overview of Dry Eye Disease for Primary Care Physicians. Medicina (Kaunas). 2025 Mar 6;61(3):460. doi: 10.3390/medicina61030460.
PubMed 40142272
Mathebula SD, Khosa PR, Maleswene MM. Comparison of patient reported dry eye symptoms as evaluated by the ocular surface disease index and symptom assessment. Afr J Prim Health Care Fam Med. 2025 May 21;17(1):e1-e7. doi: 10.4102/phcfm.v17i1.4861.
PubMed 40459105

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Acupuncture Combined With Artificial Tears Compared With Artificial Tears Alone in Moderate Dry Eye: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT07185854
Acronym / sponsor ID: ADET / AnkaraTRH-FTR-NK-09
Conditions: Dry Eye, Acupuncture
Keywords: Dry eye, Keratoconjunctivitis sicca, Acupuncture, Artificial tears, Ocular Surface Disease Index (OSDI), Schirmer test, Tear break-up time (tBUT), Complementary therapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: Nadide KocaUniversity, hospital or other
Study start: 15 Jan 2024 (actual)
Primary completion: 30 Jun 2025 (actual)
Study completion: 1 Aug 2025 (actual)
First posted: 22 Sep 2025 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Two-arm parallel group randomized controlled trial comparing artificial tears alone with artificial tears plus acupuncture in patients with moderate dry eye disease.

Arm	Type	Receives
Artificial Tears Only	Active comparator	Drug: Artificial tearsParticipants received topical artificial tears (sodium hyaluronate/CMC-based eye drops) according to standard treatment protocol. No additional intervention was given.
Experimental: Artificial Tears + Acupuncture	Experimental	Drug: Artificial tears, Other: Traditional Chinese Medicine AcupunctureParticipants received artificial tears plus acupuncture therapy, administered by a certified specialist, twice weekly for 10 sessions. Each session lasted 20 minutes.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Age between 18 and 65 years
Diagnosis of moderate dry eye disease according to TFOS DEWS II criteria
Anesthetized Schirmer test result between 5-10 mm
Tear break-up time (tBUT) between 6-10 seconds
Ocular Surface Disease Index (OSDI) score ≥ 13

Key exclusion criteria (7 listed)

Sjögren's syndrome, active blepharitis, or meibomian gland dysfunction
Systemic rheumatologic, autoimmune, or metabolic disease (e.g., diabetes)
Use of systemic or topical treatment for dry eye within the last 6 months
Previous ocular surgery
Contact lens use

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
Artificial tearsAlso: Lubricating Eye Drops, Artificial Tear Drops, Sodium Hyaluronate Eye DropsTopical artificial tears were administered as standard therapy for moderate dry eye disease.	Drug	Artificial Tears Only, Experimental: Artificial Tears + Acupuncture
Traditional Chinese Medicine AcupunctureAlso: Needle Acupuncture, Manual AcupunctureAcupuncture therapy performed by a certified specialist using sterile disposable needles at predefined local and systemic acupoints (BL2, ST1, GB1, SJ23, Ex-HN5, LI4, ST36, SP6, LIV3, GB37, GB40, Ex-HN3, Du23, BL64). Sessions were delivered twice weekly for a total of 10 sessions, each lasting 20 minutes. Deqi sensation was obtained by manual stimulation. No additional systemic or topical treatments were provided to participants in this arm.	Other	Experimental: Artificial Tears + Acupuncture

Primary outcome

Change in Ocular Surface Disease Index (OSDI) Score
Time frame: Baseline (Day 1); End of Treatment (Week 5, after 10 sessions); 1-Month Follow-up (Week 9)
The Ocular Surface Disease Index (OSDI) is a 12-item questionnaire used to assess the severity of dry eye symptoms and their impact on visual function. Scores range from 0 to 100, with higher scores indicating more severe disease. The primary outcome is the change in OSDI score from baseline to post-treatment and 1-month follow-up.

2 secondary outcomes

Change in Schirmer Test Values
Time frame: Baseline (Day 1); End of Treatment (Week 5, after 10 sessions); 1-Month Follow-up (Week 9)
Change in Tear Break-Up Time (tBUT)
Time frame: Baseline (Day 1); End of Treatment (Week 5, after 10 sessions); 1-Month Follow-up (Week 9)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
Background: PubMed 39376907Duan H, Zhou Y, Ma B, Liu R, Yang T, Chu H, Huo Z, Qi H. Effect of Acupuncture Treatment on the Ocular Pain, Mental State and Ocular Surface Characteristics of Patients with Dry Eye Disease: A Non-Randomized Pilot Study. Clin Ophthalmol. 2024 Oct 3;18:2751-2764. doi: 10.2147/OPTH.S476573. eCollection 2024.
Background: PubMed 35897025Zhang X, Zhang B, Peng S, Zhang G, Ma J, Zhu W. Effectiveness of acupuncture at acupoint BL1 (Jingming) in comparison with artificial tears for moderate to severe dry eye disease: a randomized controlled trial. Trials. 2022 Jul 27;23(1):605. doi: 10.1186/s13063-022-06486-4.
Background: PubMed 38181299Wang Y, Peng J, Xiao L, Deng Y, Lu J, Zhou YS, Yang YJ, Peng QH. Effectiveness of acupuncture combined with artificial tears in managing dry eye syndrome: A systematic review and meta-analysis. Medicine (Baltimore). 2024 Jan 5;103(1):e36374. doi: 10.1097/MD.0000000000036374.
Background: PubMed 39251947Moon SY, Chung HS, Lee JH, Lee H, Tchah H, Kim JY. Effectiveness of cyclosporine nanoemulsion eye drops in patients with mild-to-moderate dry eyes: objective and subjective evaluation. BMC Ophthalmol. 2024 Sep 9;24(1):401. doi: 10.1186/s12886-024-03620-5.
Background: PubMed 12792467Bawazeer AM, Hodge WG. One-minute schirmer test with anesthesia. Cornea. 2003 May;22(4):285-7. doi: 10.1097/00003226-200305000-00001.
Background: PubMed 38756772Kuang H, Zhu X, Chen H, Tang H, Zhao H. The immunomodulatory mechanism of acupuncture treatment for ischemic stroke: research progress, prospects, and future direction. Front Immunol. 2024 May 2;15:1319863. doi: 10.3389/fimmu.2024.1319863. eCollection 2024.
Background: PubMed 35095910Oh JE, Kim SN. Anti-Inflammatory Effects of Acupuncture at ST36 Point: A Literature Review in Animal Studies. Front Immunol. 2022 Jan 12;12:813748. doi: 10.3389/fimmu.2021.813748. eCollection 2021.
Background: PubMed 38127364McCann P, Kruoch Z, Lopez S, Malli S, Qureshi R, Li T. Interventions for Dry Eye: An Overview of Systematic Reviews. JAMA Ophthalmol. 2024 Jan 1;142(1):58-74. doi: 10.1001/jamaophthalmol.2023.5751.
Background: PubMed 33243674McMonnies CW. Why the symptoms and objective signs of dry eye disease may not correlate. J Optom. 2021 Jan-Mar;14(1):3-10. doi: 10.1016/j.optom.2020.10.002. Epub 2020 Nov 23.
Background: PubMed 40024993Villani E, Campagna G, Gentili V, Postorino EI, Genovese P, Palino P, Maini G, Carbucicchio A, Ferioli E, Nucci P, Rizzo R, Aragona P. Hydroxypropyl-Methylcellulose and GlicoPro(R) Eyedrops in the Treatment of Dry Eye Disease: In Vitro and Clinical Study. Ophthalmol Ther. 2025 Apr;14(4):787-803. doi: 10.1007/s40123-025-01101-6. Epub 2025 Mar 1.
Background: PubMed 38918902Cartes C, Aravena C, Monsalve A, Segovia C, Romero C, Quidel D, Cid F, Monsalve R, Navarro L, Araya D, Araneda D, Sepulveda M. Prevalence of Dry Eye Disease in Laser-Assisted In Situ Keratomileusis Candidates. Eye Contact Lens. 2024 Jul 1;50(7):305-310. doi: 10.1097/ICL.0000000000001095. Epub 2024 May 2.
Background: PubMed 39477774Chen A, Augello P, Asbell P, Ying GS; DREAM Research Group. The repeatability of tests for dry eye signs and symptoms in the dry eye assessment and management (DREAM) study. Cont Lens Anterior Eye. 2025 Apr;48(2):102322. doi: 10.1016/j.clae.2024.102322. Epub 2024 Oct 30.
Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the trial was conducted as a single-center interventional study and includes sensitive clinical information that cannot be sufficiently de-identified for open sharing. Aggregate results will be reported in peer-reviewed publications.

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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. This study is not recruiting at the moment.

Nadide Koca principal investigator

Department of Physical Therapy and Rehabilitation, University of Health Sciences, Ankara Training and Research Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Artificial tears and Traditional Chinese Medicine Acupuncture in people with Dry Eye and Acupuncture, run by Nadide Koca at 1 site 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Ocular Surface Disease Index (OSDI) Score (time frame: Baseline (Day 1); End of Treatment (Week 5, after 10 sessions); 1-Month Follow-up (Week 9)). 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 NCT07185854, which also lists 20 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 22 Sep 2025.