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Completed

NCT Number: NCT06725771

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.

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

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Nanjing, Jiangsu, 210029, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Sertraline Hydrochloride Tablets

Drug

Sertraline are given to patients simultaneously

Primary outcomes

  1. Hamilton Anxiety Scale (HAMA)

    Time frame: 0, 2, 4, 6 weeks

    To evaluate participant's anxiety status

Secondary outcomes

  1. Heat-Depressed on Shaoyang scale

    Time frame: 0, 2, 4, 6 weeks

    To evaluate participant's somatic symptoms, based on Chaihu Jia Longgu Muli Tang treatment

Other outcomes

  1. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 0, 2, 4, 6 weeks

    To evaluate participant's sleep disturbances status

  2. Hamilton Depression Scale (HAMD-24)

    Time frame: 0, 2, 4, 6 weeks

    To evaluate participant's depression status

Sponsors and collaborators

Lead sponsor

Lin Xiaoqian

Other

Collaborators

  • Jiangsu Province Hospital of Traditional Chinese Medicine

Registry information

Official study title

Clinical Study on the Treatment of Generalized Anxiety Disorder With Chaihu Jia Longgu Muli Tang (Bupleurum Plus Dragon Bone and Oyster Shell Decoction)

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 10, 2024
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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