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)

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

Study Overview

• Status: Completed
• Conditions: Generalised Anxiety Disorder
• Intervention / Treatment: Drug: Bupleurum Plus Dragon Bone and Oyster Shell Decoction Combined with Sertraline; Drug: Sertraline Hydrochloride Tablets

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 Type: Interventional
• Enrollment (Actual): 205
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210029
      • Jiangsu Province Hospital of TCM Affiliated Hospital of Nanjing University of Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Bupleurum Plus Dragon Bone and Oyster Shell Decoction with sertraline; observation group	Drug: Bupleurum 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
Active Comparator: Sertraline; Control group	Drug: Sertraline Hydrochloride Tablets; Sertraline are given to patients simultaneously

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Lin Xiaoqian
• Collaborators: Jiangsu Province Hospital of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): October 31, 2024
• Study Completion (Actual): October 31, 2024

Study Registration Dates

• First Submitted: December 6, 2024
• First Submitted That Met QC Criteria: December 9, 2024
• First Posted (Estimated): December 10, 2024

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 9, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Generalized Anxiety Disorder; Sertraline; Chaihu Jia Longgu Muli Tang; Heat-Depressed on Shao-Yang
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Membrane Transport Modulators; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Antidepressive Agents; Serotonin Agents; Selective Serotonin Reuptake Inhibitors; Sertraline
• Other Study ID Numbers: 2024NL-253-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No