Efficacy and Safety of Ranquilon in Patients With Anxiety Disorders Due to Neurasthenia and Adjustment Disorders
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorValenta Pharm JSC
About this trial
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 criteria
Qualifiers
Males and females aged 18 to 70 years;
Written informed consent form in accordance with current legislation;
Patients with anxiety and established diagnoses based on ICD-10 criteria: neurasthenia (F48.0) or adjustment disorder (F43.2);
Anxiety severity on the HARS scale of 18-24 points;
Disqualifiers
The patient's decision to withdraw from the study (revocation of informed consent);
Each patient has the right to discontinue participation in the study at any time without explanation. Withdrawal from the study will not affect the medical care provided to the patient in the future;
The investigator's decision that the patient needs to be excluded in the best interest of the patient;
The patient refuses to cooperate with the investigator or is non-compliant;
Trial design
Treatments tested in this trial
- Ranquilon
- Afobazole
Treatment groups
250 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov