A Non-randomized Controlled Trial Was Conducted to Observe the Improvement in the Level of HAMA in Patients With Generalized Anxiety Disorder During the 6-week Period of Oral Treatment With Chaihu Jia Longgu Muli Tang (Bupleurum Plus Dragon Bone and Oyster Shell Decoction) Combined With Sertraline.

Clinical Study on the Treatment of Generalized Anxiety Disorder With Chaihu Jia Longgu Muli Tang (Bupleurum Plus Dragon Bone and Oyster Shell Decoction)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06725771

Enrollment

205

Registered

2024-12-10

Start date

2022-09-01

Completion date

2024-10-31

Last updated

2024-12-10

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

Conditions

Generalised Anxiety Disorder

Keywords

Generalized Anxiety Disorder, Chaihu Jia Longgu Muli Tang, Sertraline, Heat-Depressed on Shao-Yang

Brief summary

The purpose of this study is to clinically observe the efficacy of Bupleurum Plus Dragon Bone and Oyster Shell Decoction in the treatment of Generalized Anxiety Disorder to improve the scores of HAMA

Detailed description

Generalized Anxiety Disorder, not only results in a disturbed psychological condition, but even daily life with coworkers and family will also be disrupted. Chaihu Jia Longgu Muli Tang (Bupleurum Plus Dragon Bone and Oyster Shell Decoction), a compound Chinese herbal medicine found in Treatise on Cold Damage, has been used for treating mental disorders with symptoms such as chest distress, irritability, being frightened, etc since the China Han dynasty. In this study, we will observe the efficacy of this formula, in order to provide an evidence-based basis for clinical observation and evaluation of Generalized Anxiety Disorder.

Interventions

DRUGBupleurum Plus Dragon Bone and Oyster Shell Decoction Combined with Sertraline

Bupleurum Plus Dragon Bone and Oyster Shell Decoction and Sertraline are given to patients simultaneously

DRUGSertraline Hydrochloride Tablets

Sertraline are given to patients simultaneously

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Meets the western medical diagnostic criteria for generalized anxiety disorder; * The TCM diagnosis is Heat-Depressed on Shao-Yang (rè yù shǎo yáng) type; * Hamilton Anxiety Scale (HAMA) score ≥ 7; * Age 18-80 years old.

Exclusion criteria

* Allergy to Chinese Medicine formulas; * Pregnant or breastfeeding; * Suicidal ideation and suicide attempt; * Substance use disorders; * Severe cardiovascular diseases liver diseases and kidney diseases.

Design outcomes

Primary

Measure	Time frame	Description
Hamilton Anxiety Scale (HAMA)	0, 2, 4, 6 weeks	To evaluate participant's anxiety status

Secondary

Measure	Time frame	Description
Heat-Depressed on Shaoyang scale	0, 2, 4, 6 weeks	To evaluate participant's somatic symptoms, based on Chaihu Jia Longgu Muli Tang treatment

Other

Measure	Time frame	Description
Pittsburgh Sleep Quality Index (PSQI)	0, 2, 4, 6 weeks	To evaluate participant's sleep disturbances status
Hamilton Depression Scale (HAMD-24)	0, 2, 4, 6 weeks	To evaluate participant's depression status

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026