Efficacy Study of Abdominal Massage Therapy to Treat Generalized Anxiety Disorder of Deficiency of Both Heart and Spleen Type

Anxiety Disorders Clinical Trial

Official title:

Study of Abdominal Massage Therapy for Generalized Anxiety Disorder Based on the " Essence Fosters Spirit " Theory

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02186366
• Other study ID #: TECF 20120210
• Status: Recruiting
• Phase: N/A
• First received: June 23, 2014
• Last updated: September 1, 2014
• Start date: September 2014

Study information

• Verified date: September 2014
• Source: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
• Contact: Jennifer Gao, Master
• Phone: 022-27432929
• Email: jennifergao1982[@]126.com
• Is FDA regulated: No
• Health authority: China: Ministry of HealthChina: Food and Drug AdministrationChina: Tianjin Education Commission for Higher Education
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 50 Years

Eligibility

Inclusion Criteria:

• Meet criteria for a primary diagnosis of current GAD as demonstrated by a structured clinical interview for Diagnostic and Statistical Manual -IV(DSM-IV);meet a diagnosis of Deficiency of both heart and spleen type.

• The scores of SAS=50, 24=the scores of HAMD =15.

• The symptoms of anxiety have continued not less than 6months.

Exclusion Criteria:

• major depression, schizophrenia ,bipolar disease other psychotic disorders, drug-dependent persons;

• patients with severe suicidal tendencies;

• women in pregnancy or breastfeeding, menstrual or postpartum recovery;

• suffered from serious illness or impairment of system,such as heart and brain blood vessels, lungs, liver, kidneys and blood system.

• persons allergic to Buspirone and excipient;

• persons suffering from epilepsy or hypertension or Glaucoma or myasthenia gravis or leukopenia;

• persons must be taking monoamine oxidase inhibitors;

• persons who drink a lot;

• persons with the local skin lesions in abdomen damage (such as damage, Burns, etc);

• persons with abdominal visceral tumors, nodules, inflammation, edema, abdominal aortic atherosclerosis;

• persons without the incompetence or unable to read, write and understand independently;

• persons whom the researchers believe should not participate in this study.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders

Intervention

Other:
• Abdominal Massage Therapy
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.

Drug:
• Buspirone
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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Sun Qing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	content of Norepinephrine in blood plasma	We will test the content of Norepinephrine of participants in blood plasma and record the data.	baseline and post- 6week intervention	No
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Primary	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	No
Secondary	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	No
Secondary	Scores of self-rating anxiety scale( SAS)	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	No
Secondary	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	No
Secondary	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	No