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Randomized, Double-Blind, Placebo-Controlled Clinical Study on Milnacipran Hydrochloride Tablets for the Treatment of Somatic Cough Disorder

Randomized, Double-Blind, Placebo-Controlled Clinical Study on Milnacipran Hydrochloride Tablets for the Treatment of Somatic Cough Disorder

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109820
Enrollment
Unknown
Registered
2025-09-25
Start date
2025-10-09
Completion date
Unknown
Last updated
2025-09-29

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

Conditions

somatic cough disorder

Interventions

Test Group:Milnacipran Pharmacotherapy

Sponsors

ShangHai Tongji Hospita
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Before any assessment is conducted, the patient or their legal representative must sign an informed consent form; (2) Aged between 18 and 70 years old (inclusive), with no restriction on gender; (3) Meeting the diagnosis of somatoform cough disorder.

Exclusion criteria

Exclusion criteria: (1) Pregnant or lactating women, or those who refuse to sign the informed consent form; (2) Current smokers or those who have quit smoking for <= 2 years; (3) Those with a history of respiratory tract infection within 8 weeks; (4) Those with hepatic or renal insufficiency; (5) Those with a known allergy to milnacipran; (6) Patients taking non-selective MAO inhibitors, selective MAO-B inhibitors, cardiac glycosides, or 5HT1D agonists; (7) Patients with severe psychotic disorders or substance dependence (including: bipolar affective disorder, schizophrenia, and those with manifestations such as mania or suicidal attempts); (8) Patients with severe hypertension, cardiovascular and cerebrovascular diseases, autoimmune diseases, or allergic reactions; (9) Patients with organic brain damage or ataxia; (10) Patients with dysuria or a history of dysuria, glaucoma or increased intraocular pressure, and those with convulsive diseases (such as epilepsy) or a history of such diseases; (11) Patients with a previous bleeding disorder who are also taking anticoagulants (e.g., non-steroidal anti-inflammatory drugs, aspirin, and other drugs that may increase the risk of bleeding); (12) Other circumstances deemed by the researcher to make the individual unsuitable for participation in the study.

Design outcomes

Primary

MeasureTime frame
Cough Visual Analog Scale;Cough Symptom Score;

Secondary

MeasureTime frame
The Somatic Symptom Disorder - B Criteria Scale;Multidimensional Depression Inventory (MDI);Leicester Cough Questionnaire (LCQ);Generalized Anxiety Disorder-7 (GAD-7);Results of Capsaicin Cough Sensitivity Test;Results of Sputum Supernatant Test (Induced Sputum);

Countries

China

Contacts

Public ContactWu Heng

ShangHai Tongji Hospita

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

Outcome results

None listed

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