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)
1 other identifier
interventional
205
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2024
CompletedFirst Submitted
Initial submission to the registry
December 6, 2024
CompletedFirst Posted
Study publicly available on registry
December 10, 2024
CompletedDecember 10, 2024
December 1, 2024
2.2 years
December 6, 2024
December 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hamilton Anxiety Scale (HAMA)
To evaluate participant's anxiety status
0, 2, 4, 6 weeks
Secondary Outcomes (1)
Heat-Depressed on Shaoyang scale
0, 2, 4, 6 weeks
Other Outcomes (2)
Pittsburgh Sleep Quality Index (PSQI)
0, 2, 4, 6 weeks
Hamilton Depression Scale (HAMD-24)
0, 2, 4, 6 weeks
Study Arms (2)
Bupleurum Plus Dragon Bone and Oyster Shell Decoction with sertraline
EXPERIMENTALobservation group
Sertraline
ACTIVE COMPARATORControl group
Interventions
Bupleurum Plus Dragon Bone and Oyster Shell Decoction and Sertraline are given to patients simultaneously
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Allergy to Chinese Medicine formulas;
- Pregnant or breastfeeding;
- Suicidal ideation and suicide attempt;
- Substance use disorders;
- Severe cardiovascular diseases liver diseases and kidney diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jiangsu Province Hospital of TCM Affiliated Hospital of Nanjing University of Chinese Medicine
Nanjing, Jiangsu, 210029, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Jiangsu Province Hospital of TCM Affiliated Hospital of Nanjing University of Chinese Medicine
Study Record Dates
First Submitted
December 6, 2024
First Posted
December 10, 2024
Study Start
September 1, 2022
Primary Completion
October 31, 2024
Study Completion
October 31, 2024
Last Updated
December 10, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share