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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.

NCT ID: NCT06725771

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2024-10-31

Brief Summary

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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

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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.

Conditions

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Generalised Anxiety Disorder

Keywords

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bupleurum Plus Dragon Bone and Oyster Shell Decoction with sertraline

observation group

Group Type EXPERIMENTAL

Bupleurum Plus Dragon Bone and Oyster Shell Decoction Combined with Sertraline

Intervention Type DRUG

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

Sertraline

Control group

Group Type ACTIVE_COMPARATOR

Sertraline Hydrochloride Tablets

Intervention Type DRUG

Sertraline are given to patients simultaneously

Interventions

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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

Intervention Type DRUG

Sertraline Hydrochloride Tablets

Sertraline are given to patients simultaneously

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jiangsu Province Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Lin Xiaoqian

OTHER

Sponsor Role lead

Responsible Party

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Lin Xiaoqian

Jiangsu Province Hospital of TCM Affiliated Hospital of Nanjing University of Chinese Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Jiangsu Province Hospital of TCM Affiliated Hospital of Nanjing University of Chinese Medicine

Nanjing, Jiangsu, China

Site Status

Countries

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China

Other Identifiers

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2024NL-253-02

Identifier Type: -

Identifier Source: org_study_id