A Study of the Efficacy and Safety of Ranquilon Tablets in Patients With Anxiety in Neurasthenia and Adjustment Disorders

Inclusion Criteria:

1. Men and women between the ages of 18 and 70
2. Presence of written consent to participate in the study in accordance with applicablelaw
3. Patients with anxiety and diagnoses based on ICD-10 criteria: neurasthenia (F48.0) oradjustment disorder (F43.2)
4. HARS anxiety scores of 18-24
5. Severity of asthenia on the Asthenia Self Assessment Scale (MFI-20) of more than 50points
6. Hamilton Depression Assessment Scale (HAMD-17) score < 6
7. CGI-s scale score of at least 4
8. Negative pregnancy test for women of preserved reproductive potential
9. Consent to use effective contraception for the duration of the study and 30 days aftercompletion (for women of unresolved reproductive potential and men)
10. Ability to understand the requirements for study participants, to give written consentto participate in the study (including the use and communication of patient healthinformation relevant to the study) and to comply with the procedures of the studyprotocol

Exclusion Criteria:

1. Known intolerance to the active ingredient and/or excipients in the study drug/placeboof the study drug
2. Known presence of lactase deficiency, lactose intolerance, glucose-galactosemalabsorption or galactose intolerance
3. Patients who require concomitant therapy prohibited in this study (MAO inhibitors,antidepressants, neuroleptics, anxiolytics and sedatives (including herbal), sleepingpills when used on a continuous basis), or have taken these drugs within the lastmonth
4. Established or suspected alcohol/drug use at the time of screening or randomization,and/or a history of alcohol, drug or drug dependence
5. Presence of cancer, including a history of cancer (with the exception of a cured tumorwith sustained remission for more than 5 years)
6. Presence of tuberculosis, including a history of tuberculosis
7. The presence of HIV, chronic viral hepatitis B/C, syphilis (including a history), or apositive test for HIV, hepatitis B/C, syphilis at screening
8. Patients with a diagnosis established on the basis of ICD-10 criteria: other anxietydisorders (F41)
9. Schizophrenia, schizoaffective, affective and panic disorders
10. Acute psychosis (endogenous-procedural, organic or somatogenic), including history
11. Organic lesions of the central nervous system of traumatic and alcoholic genesis
12. Postencephalitic syndrome
13. Brain tumors, including in the anamnesis
14. Degenerative diseases of the central nervous system (CNS), in particular, multiplesclerosis
15. Depression, including a history of depression
16. Generalized anxiety disorder, including a history
17. Suicidal thoughts or ideas; a history of suicide attempts
18. Epilepsy, seizures, including a history of seizures
19. Diabetes mellitus at the stage of decompensation
20. Established diagnosis of chronic kidney disease stage 3A or higher, or glomerularfiltration rate (GFR) calculated by the Cockcroft-Gault formula = 59 ml/min/1.73 m2 orless
21. Established diagnosis of hepatic failure of any severity, or elevated ALT, AST ortotal bilirubin, urea >3 times the upper limit of normal values
22. Conditions after major surgical interventions, if less than six months have elapsedsince the intervention
23. Chronic heart failure New York Heart Association (NYHA) functional class III-IV
24. Severe, decompensated, or unstable disease (any disease or condition that threatensthe patient's life or worsens the patient's prognosis, or makes it impossible toperform a clinical trial in the patient)
25. Pregnant women, women breastfeeding, or women planning to become pregnant during thestudy and 30 days after study participation ends
26. Refusal by the patient to use approved contraception or to completely abstain fromsexual intercourse during the entire period of study participation, beginning at Visit 0, and for 30 days after completion of study participation
27. Patient's current or planned participation in psychological or psychotherapeuticinterventions designed to treat an anxiety disorder during the course of the clinicaltrial
28. Participation in any other clinical trial within 90 days prior to the screening period
29. Lack of willingness to cooperate on the part of the patient
30. Other reasons that, in the opinion of the investigator, prevent the patient fromparticipating in the study or pose an unreasonable risk to the patient Withdrawal Criteria:
31. Patient's desire to stop participating in the study (withdrawal of informed consent)Each patient has the right to stop participating in the study at any time withoutgiving a reason. Withdrawal from the study will not affect the medical care providedto the patient in the future.
32. A decision by the research physician that the patient should be excluded is in thepatient's own best interest
33. Patient refuses to cooperate with the investigator or is undisciplined
34. Causes/occurrence of situations during the study that threaten patient safety (e.g.,hypersensitivity reactions, SAE, etc.)
35. Inclusion of a patient in the study with inclusion/inclusion criteria not met (priorto randomization)
36. Significant violation of the treatment regimen A significant violation is defined asa) skipping study drug/placebo for 2 consecutive full days or more, or b) taking, intotal, < 80% or >120% of the full course (full course = 168 pills)
37. Positive pregnancy test
38. Confirmed diagnosis of COVID-19
39. Occurrence in the course of the study of other reasons that prevent the studyaccording to the protocol
40. Death of a patient