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The efficacy and safety of 'Antianxiety Granule' in anxiety disorder: A multicenter, randomized, double-blind, placebo parallel controlled trial

The efficacy and safety of 'Antianxiety Granule' in anxiety disorder: A multicenter, randomized, double-blind, placebo parallel controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800016039
Enrollment
Unknown
Registered
2018-05-08
Start date
2018-06-01
Completion date
Unknown
Last updated
2019-04-23

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

Conditions

anxiety disorder

Interventions

Experimental group:Antianxiety granule

Sponsors

Shanghai Municipal Hospital of Traditonal Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Outpatient aged 18-70 years male or female; 2. Subject fulfilled the revised the ICD - 10 in the diagnosis criteria of GAD; 3. Patients who never taking other anxiolytics or have stopped it for more than half a month; 4. HAMA score T > 14; 5. Patients who have well compliance and take the granule for 6 weeks and followed up for 1 week; 6. Voluntary participation,signature of informed consent; 7. It is one of the Diagnosis and Treatment Scheme for Anxiety Disorder of TCM that is in line with the Internal Medicine of TCM and the key specialty of the Depression Center of Shanghai Municipal Hospital of Traditional Chinese Medicine; 8. Severe criteria:Patients with poorer psychosocial functioning, and feel pain because he is unbearable and unable to escape; Disease criteria:Meet the symptom criteria for at least 6 months.

Exclusion criteria

Exclusion criteria: 1. Elimination of Organic Psychosyndrome, or Anxiety Disorders caused by psychoactive substances and non-addictive substances; 2. Currently pregnant or lactating or women of childbearing age but cant take contraceptive during treatment; 3. With obvious heart,liver,kidney or other systemic symptoms; 4. Laboratory tests and ECG showed clinically significant abnormalities, and investigators judge it may influence the evaluation of the granule or the subject's safety; 5. AST, ALT exceeds 2.0 times the upper limit of normal; 6. Patients who has paticipated in other drug clinical trials in 4 weeks; 7. HAMD score T =18.

Design outcomes

Primary

MeasureTime frame
Hamilton Anxiety Scale;

Secondary

MeasureTime frame
State&Trait Anxiety Scale;

Countries

China

Contacts

Public ContactJian Xu

Shanghai Municipal Hospital of Traditional Chinese Medicine

0296@szy.sh.cn+86 13901781509

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026