Generalised anxiety disorder
Conditions
Interventions
Test group:Baihe Ningshen Granules + Buspirone Tablet Analogue
Positive drug control group:Baihe Ningshen Granules Analogue + Buspirone Tablets
Sponsors
Beijing Anding Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: ? Meet the DSM-5 western medical diagnostic criteria for generalised anxiety disorder and the 2022 Expert Consensus of the Chinese Society for Integrative Medicine's Committee on Mental Diseases on "Expert Consensus on Chinese Medicine Symptom Identification and Quantitative Grading Criteria for Generalised Anxiety Disorder" before enrolment; Meet the Chinese medicine diagnostic criteria for the yin-deficiency and internal-heat type of generalised anxiety disorder before enrolment; ? Age =18 years old and =70 years old, gender is not limited; ?Baseline HAMA score before enrolment =14 and =29 points, of which the score of anxiety (item 1) =2 points and the score of depression (item 6) =2 points; ? The rate of reduction of baseline HAMA score before enrolment compared with that at screening is <25%; ? Voluntarily participate in this clinical trial, can cooperate with the investigator to carry out the trial, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: ?Comorbidity with any of the following psychiatric disorders: delusional disorder, dissociative anxiety disorder, panic disorder, agoraphobia, anxiety disorders due to other physical illnesses, substance/drug-induced anxiety disorders, social anxiety disorder (social phobia), obsessive-compulsive disorder, post-traumatic stress disorder and adjustment disorders, depression, bipolar and psychotic disorders, anorexia nervosa; ? People with mental disorders associated with other diseases; ?Comorbidity with any substance-related and addictive disorder, including alcohol, caffeine, cannabis, hallucinogens, inhalants, opioids, sedatives, hypnotic drugs, stimulants, tobacco, etc.; ?Persons with a history of severe drug allergy or hypersensitivity reaction, known or suspected history of allergy or serious adverse reaction to the test drug and its excipients, and allergic constitution; ? Females who are pregnant, breastfeeding, or have plans to give birth within 6 months; ?Received treatment with buspirone tablets within 2 weeks prior to screening; ?Those who are at risk of hypotension or whose systolic blood pressure is found to be =80mmHg and diastolic blood pressure is found to be =50mmHg at the time of screening; ? Received or could not discontinue the following drugs during the trial within 2 weeks before screening: 1) Calcium antagonists (e.g., carnidipine, amlodipine, nifedipine, etc.); 2) Butyrophenyl drugs (e.g., haloperidol, spiperone, etc.); 3) selective 5-HT reuptake inhibitors (e.g. paroxetine, citalopram, escitalopram, sertraline, fluvoxamine); (4) 5-HT receptor antagonists and reuptake inhibitors (e.g., trazodone); 5) Tricyclic and heterocyclic drugs (e.g., promethazine, doxepin, amoxapine, maprotiline); 6) antipsychotics (e.g., phenazopyridine, sulpiride, risperidone, quetiapine, olanzapine, etc.); 7) Calcium antagonists (e.g. Carnidipine, Amlodipine, Nifedipine, etc.); 8) butyrophenyl drugs (e.g. haloperidol, spironolactone, etc.); 9) Delisin, St John's wort-containing preparations, etc; 10) Affective stabilisers (e.g. lithium salts, valproate, etc.); ? Previously received or inability to discontinue systemic psychotherapy during the trial; ?HAMD-24 score =20; ?Persons with suicidal tendencies as judged by the investigator; ? people with glaucoma, myasthenia gravis, leukopenia and allergy to buspirone tablets; ? Abnormal liver or kidney function: ALT or AST = 1.5 times of the upper limit of normal, or SCr > upper limit of normal; ? Those who have participated in other drug clinical trials within 3 months before screening; ? Other conditions that the investigator considers inappropriate for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of reduction in HAMA score from baseline at week 8 of the treatment period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of reduction in HAMA score from baseline at week 4 of the treatment period and weeks 4 and 8 of the follow-up period;Proportion of subjects with =50% reduction in HAMA score at weeks 2, 4 and 8 of the treatment period and weeks 4 and 8 of the follow-up period;Proportion of subjects with =50% reduction in HAMA score at weeks 2, 4 and 8 of the treatment period and weeks 4 and 8 of the follow-up period;Change from baseline in HAMA psychoanxiety factor scores at weeks 2, 4 and 8 of the treatment period and weeks 4 and 8 of the follow-up period;Change from Baseline in HAMA Somatic Anxiety Factor Scores at Weeks 2, 4, and 8 of the Treatment Period and Weeks 4 and 8 of the Follow-up Period;Decrease in QOL score from baseline at weeks 2, 4 and 8 of the treatment period and weeks 4 and 8 of the follow-up period;Decrease in CGI-S score from baseline at weeks 2, 4 and 8 of the treatment period and at weeks 4 and 8 of the follow-up period;Decrease in CGI-I score from baseline at weeks 2, 4 and 8 of the treatment period and at weeks 4 and 8 of the follow-up period;Reductions in TCM evidence scores from baseline at weeks 2, 4 and 8 of the treatment period and weeks 4 and 8 of the follow-up period;Rate of reduction from baseline in SAS scores at weeks 2, 4 and 8 of the treatment period and at weeks 4 and 8 of the follow-up period;Rate of reduction from baseline in SDS scores at weeks 2, 4 and 8 of the treatment period and weeks 4 and 8 of the follow-up period;Recurrence at weeks 4 and 8 of the follow-up period; | — |
Countries
China
Contacts
Public ContactJia Hongxiao
Beijing Anding Hospital, Capital Medical University
Outcome results
None listed