A Non-randomized Controlled Trial Was Conducted to Observ... | NCT06725771

Studies
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.

NCT06725771

Sponsor

Lin Xiaoqian

Status

Completed

Last Update Posted

Dec 10, 2024Actual

Enrollment

205Actual

Phase

Not Applicable

Conditions

Generalised Anxiety Disorder

Interventions

Bupleurum Plus Dragon Bone and Oyster Shell Decoction Combined with Sertraline
Sertraline Hydrochloride Tablets

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Brief Title

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.

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2022Actual

Primary Completion Date

Oct 31, 2024Actual

Completion Date

Oct 31, 2024Actual

First Submitted Date

Dec 6, 2024

First Submission Date that Met QC Criteria

Dec 9, 2024

First Posted Date

Dec 10, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 9, 2024

Last Update Posted Date

Dec 10, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Lin Xiaoqian, Jiangsu Province Hospital of TCM Affiliated Hospital of Nanjing University of Chinese Medicine, Jiangsu Province Hospital of Traditional Chinese MedicineSponsor-Investigator

Lead Sponsor

Lin XiaoqianOTHER

Collaborators

Name	Class
Jiangsu Province Hospital of Traditional Chinese Medicine	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

205Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Bupleurum Plus Dragon Bone and Oyster Shell Decoction with sertraline	Experimental	observation group	Drug: Bupleurum Plus Dragon Bone and Oyster Shell Decoction Combined with Sertraline
Sertraline	Active Comparator	Control group	Drug: Sertraline Hydrochloride Tablets

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bupleurum Plus Dragon Bone and Oyster Shell Decoction Combined with Sertraline	Drug	Bupleurum Plus Dragon Bone and Oyster Shell Decoction and Sertraline are given to patients simultaneously

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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 Outcomes

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

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jiangsu Province Hospital of TCM Affiliated Hospital of Nanjing University of Chinese Medicine		Nanjing	Jiangsu	210029	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D001008	Anxiety Disorders
D001523	Mental Disorders

ID	Term
D015057	1-Naphthylamine
D000588	Amines
D009930	Organic Chemicals
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D011083	Polycyclic Compounds