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.

Lin Xiaoqian

Status: Completed

Conditions: Generalised Anxiety Disorder

Treatments: Drug: Sertraline Hydrochloride Tablets; Drug: Bupleurum Plus Dragon Bone and Oyster Shell Decoction Combined with Sertraline

Study type: Interventional

Funder types: Other

Identifiers

NCT06725771

2024NL-253-02

Details and patient eligibility

About

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

Full 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.

Enrollment: 205 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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205 participants in 2 patient groups

Bupleurum Plus Dragon Bone and Oyster Shell Decoction with sertraline

Experimental group

Description:

observation group

Treatment:

Drug: Bupleurum Plus Dragon Bone and Oyster Shell Decoction Combined with Sertraline

Sertraline

Active Comparator group

Description:

Control group

Treatment:

Drug: Sertraline Hydrochloride Tablets