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.

Not Applicable

Completed

• Conditions: Generalised Anxiety Disorder
• Interventions: Drug: Bupleurum Plus Dragon Bone and Oyster Shell Decoction Combined with Sertraline; Drug: Sertraline Hydrochloride Tablets

• Registration Number: NCT06725771
• Lead Sponsor: Lin Xiaoqian

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.

Study Timeline

• Study Start: 2022-09-01
• Primary Completion: 2024-10-31
• Study Completion: 2024-10-31
• Status Verified: 2024-12
• Study First Submitted: 2024-12-06
• Study First Submitted QC: 2024-12-09
• Last Update Submitted: 2024-12-09
• Study First Posted: 2024-12-10
• Last Update Posted: 2024-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bupleurum Plus Dragon Bone and Oyster Shell Decoction with sertraline	Bupleurum Plus Dragon Bone and Oyster Shell Decoction Combined with Sertraline	observation group
Sertraline	Sertraline Hydrochloride Tablets	Control group

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Jiangsu Province Hospital of TCM Affiliated Hospital of Nanjing University of Chinese Medicine; 🇨🇳 Nanjing, Jiangsu, China