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Generalized Anxiety Disorder (GAD) is characterized by the presence of persistent worry or fear of no explicit object and fixed content, or things that might occur in real life,which not corresponds with the realities. Patients with GAD may occur a series of somatic symptoms including muscle tension, backaches, headaches, fatigue, insomnia, restlessness, as well as psychological feelings of anxiety, worry and feeling overwhelmed. And it always brings some type of functional disability or decrease in quality of life. GAD is treated by Selective Serotonin Reuptake Inhibitors (SSRIs) or Serotonin, Norepinephrine Reuptake Inhibitors(SNRI) and 5-ht1a receptor agonists as regular medication which have the definite effects. But, some adverse reaction of SSRIs or SNRI leads to the compliance of taking medicine of patients with GAD. There is an impressive data suggesting that Abdominal Massage Therapy is effective in decreasing some symptoms of somatic symptoms and psychological feelings.
This study is designed as a parallel group, positive control, non-inferiority study. It will recruit 140 cases of generalized anxiety disorder of deficiency of both heart and spleen type. Both the treatment group and the control group will be randomly assigned 70 cases. Patients in the treatment group will be treated by Abdominal Massage for 6 weeks,and the control group by buspirone . The total study includes 4 views that are respectively before the treatment,after 3 weeks treatment, after the whole treatment , and 3 months after the whole treatment. At all of the 4 views, all participants will be estimated the scores of Hamilton Depression Scale(HAMD) ,self-rating anxiety scale(SAS), and Quality of life assessment scale. At the second, third and the forth views, all participants will be estimated Clinical Global Impression ( CGI). At the first and the third views, all participants will be collected the data of content of hydroxytryptamine(5-HT), Norepinephrine and total cortisol in blood plasma, and of blood stream speed, vascular resistance index and pulsatility index of middle cerebral artery (MCA), anterior cerebral artery(ACA), posterior cerebral artery (PCA) and basilar artery(BA). This study aims to investigate the efficacy of Abdominal Massage Therapy vs. buspirone, and discover the correlation between these scales and these objective indicators.
Quality control: The study site and all researchers must comply with the required qualifications. All researchers must be trained before the study. The study will take a number of measures to ensure the recruitment of the required sample size, and compliance of intervention providers and participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abdominal Massage Therapy | Experimental | Abdominal Massage Therapy , 30 minutes, three times one week for 6 weeks |
|
| Buspirone | Active Comparator | Buspirone by mouth 5mg three times per day for 6week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abdominal Massage Therapy | Other | Abdominal Massage Therapy , 30 minutes, three times one week for 6 weeks. If the subjects have recovered in the treatment of 6 weeks, we can end treatment early. |
| Measure | Description | Time Frame |
|---|---|---|
| reductive rate of Hamilton Depression Scale( HAMD reductive rate) | We will estimate the scores of the Hamilton Depression Scale of participants at baseline and post- 6week intervention,then calculate the HAMD reductive rate according to the following formula:HAMD reductive rate=(scores of HAMD at baseline - scores of HAMD at post- 6week intervention )/ scores of HAMD at baseline×100% | baseline and post- 6week intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Scores of Hamilton Depression Scale(HAMD) | We will estimate the scores of the Hamilton Depression Scale of participants. | baseline, post- 3week intervention, post- 6week intervention and post-3month after 6- week intervention |
| Scores of self-rating anxiety scale( SAS) |
| Measure | Description | Time Frame |
|---|---|---|
| content of 5-HT in blood plasma | We will test the content of 5-HT of participants in blood plasma and record the data. | baseline and post- 6week intervention |
| content of Norepinephrine in blood plasma |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Gao, Master | Contact | 022-27432929 | 13920595861 | jennifergao1982@126.com |
| James Zhang, Master | Contact | 022-27432929 | 13820590796 | james399@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine | Recruiting | Tianjin | Tianjin Municipality | 300193 | China |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002065 | Buspirone |
| ID | Term |
|---|---|
| D013141 | Spiro Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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|
| Buspirone | Drug | Buspirone by mouth 5mg three times per day for 6week. If the subjects have recovered in the treatment of 6 weeks, we can end treatment early. |
|
|
We will estimate the scores of the self-rating anxiety scale of participants. |
| baseline, post- 3week intervention, post- 6week intervention and post-3month after 6- week intervention |
| Scores of Quality of life assessment scale | We will estimate the scores of the Quality of life assessment scale of participants. | baseline, post- 3week intervention, post- 6week intervention and post-3month after 6- week intervention |
| Scores of Clinical Global Impression | We will estimate the scores of Clinical Global Impression. | post- 3week intervention and post- 6week intervention and post-3month after 6- week intervention |
We will test the content of Norepinephrine of participants in blood plasma and record the data.
| baseline and post- 6week intervention |
| content of total cortisol in blood plasma | We will test the content of total cortisol of participants in blood plasma and record the data. | baseline and post- 6week intervention |
| blood stream speed of MCA, ACA, PCA and BA | We will test blood stream speed of MCA, ACA, PCA and BA of patients by Transcranial Doppler and record the data. | baseline and post- 6week intervention |
| vascular resistance index of MCA, ACA, PCA and BA | We will test vascular resistance index of MCA, ACA, PCA and BA of patients by Transcranial Doppler and record the data. | baseline and post- 6week intervention |
| pulsatility index of MCA, ACA, PCA and BA | We will test pulsatility index of MCA, ACA, PCA and BA of patients by Transcranial Doppler and record the data. | baseline and post- 6week intervention |
| D010879 |
| Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
| D011083 | Polycyclic Compounds |