RecruitingPhase 4NCT06843044

Efficacy and Safety of Ranquilon in Patients With Anxiety Disorders Due to Neurasthenia and Adjustment Disorders

An Open-label, Comparative, Randomized, Multicenter Phase IV Clinical Study to Evaluate the Clinical Efficacy and Safety of the Drug Ranquilon, Tablets, 1 mg, in Patients With Anxiety Disorders Due to Neurasthenia and Adjustment Disorders


Sponsor

Valenta Pharm JSC

Enrollment

250 participants

Start Date

Jan 13, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Study is to evaluate the efficacy and safety of the drug Ranquilon, 1 mg tablets, at a dosage of 6 mg/day compared to the drug Afobazole, 10 mg tablets, at a dosage of 30 mg/day for the treatment of patients with anxiety disorders due to neurasthenia and adjustment disorders.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a medication called Ranquilon can safely and effectively reduce anxiety in adults diagnosed with neurasthenia (a condition causing persistent mental and physical exhaustion) or adjustment disorder (difficulty coping after a stressful life event). **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with neurasthenia or adjustment disorder based on standard criteria - You have moderate anxiety symptoms (as measured by a standard anxiety scale) - You do not have severe suicidal thoughts - You experience significant fatigue **You may NOT be eligible if...** - You have severe anxiety or a formal psychiatric diagnosis beyond the conditions above - You are currently taking psychiatric medications - You have serious physical health problems that could interfere with the study - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRanquilon

1 mg tablets

DRUGAfobazole

10 mg tablets


Locations(6)

Engels Psychiatric Hospital State Health Care Institution of the Ministry of Health of the Saratov Region

Engel's, Russia

Unimed-C Jsc

Moscow, Russia

Aurora MedFort LLC

Saint Petersburg, Russia

Limited Liability Company "Research Center Eco-Safety"

Saint Petersburg, Russia

Limited Liability Company "Stepmed Clinic"

Saint Petersburg, Russia

Saratov City Psychoneurological Dispensary

Saratov, Russia

View Full Details on ClinicalTrials.gov

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NCT06843044


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