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Randomized, double-blind, and placebo-controlled clinical study of Milnacipran hydrochloride tablets combined with transcranial magnetic stimulation in the treatment of somatic cough disorders

Randomized, double-blind, and placebo-controlled clinical study of Milnacipran hydrochloride tablets combined with transcranial magnetic stimulation in the treatment of somatic cough disorders

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083771
Enrollment
Unknown
Registered
2024-04-30
Start date
2024-05-01
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

somatic cough disorders

Interventions

Combined treatment group:receiving both Milnacipran and true rTMS
Medication group:receiving both Milnacipran and false rTMS

Sponsors

Shanghai Tongji Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: (1) Before conducting any assessment, the patient or their legal representative must sign an informed consent form; (2) 18 years old = Age = 60 years old, regardless of gender; (3) The main symptom is cough, which lasts for more than 8 weeks and there are no obvious abnormalities in the chest X-ray; Chronic cough patients who have undergone comprehensive examination according to the Chinese Guidelines for the Diagnosis and Treatment of Cough (2015) but still cannot determine the cause of the disease, or who have not responded to treatment for known causes; (4) Subject cough visual analogue scale (VAS) = 30mm; (5) Complies with the Diagnostic and Statistical Manual for Mental Disorders, 5th edition (DSM-5) Diagnostic Criteria for Physical Symptom Disorders: A. Has one or more physical symptoms that cause significant mental distress or disrupt the patient's daily life; B. Excessive thinking, feelings, or behaviors related to physical symptoms or health concerns, manifested as one of the following phenomena: ? persistent and disproportionate thoughts about the severity of one's own symptoms; ? persistent high levels of anxiety about health or symptoms; ? excessive time and energy invested in these symptoms or health concerns; C. Although a physical symptom may not persist, the symptomatic state is persistent (typically longer than 6 months); (6) Physical Symptom Disorder Diagnosis B Standard Scale (SSD-12) = 16 points, Rapid Rating Depression Scale (MDI) = 18 points, and Generalized Anxiety Scale (GAD-7) = 10 points.

Exclusion criteria

Exclusion criteria: The exclusion criteria for cases in this study are as follows: (1) Pregnant or lactating women or those who refuse to sign informed consent forms; (2) Smoking or quitting smoking for = 2 years; (3) Have a history of respiratory infections within 8 weeks; (4) Patients with renal insufficiency, pregnant women, and lactating women; (5) Patients who need to take ACEI drugs for a long time; (6) Other psychiatric disorders or drug addicts; (7) Individuals with hypertension and other cardiovascular diseases; (8) Subjects with a history of epileptic seizures and contraindications to rTMS such as implanted metal medical devices; (9) The researchers believe that there are other situations that are not suitable for entry into the study.

Design outcomes

Primary

MeasureTime frame
Cough Visual Analog Scale ;The Somatic Symptom Disorder - B Criteria Scale;

Secondary

MeasureTime frame
Cough Symptom Score;Capsaicin cough sensitivity;Multidimensional Depression Inventory (MDI);

Countries

China

Contacts

Public ContactWU HENG

Shanghai Tongji Hospital

hengwu@tongji.edu.cn+86 138 1686 2331

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026