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

NCT ID: NCT02186366

Last Updated: 2014-09-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30

Brief 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.

Detailed 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.

Conditions

Anxiety Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Abdominal Massage Therapy

Abdominal Massage Therapy , 30 minutes, three times one week for 6 weeks

Group Type: EXPERIMENTAL

Buspirone

Intervention Type: 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.

Buspirone

Buspirone by mouth 5mg three times per day for 6week

Group Type: ACTIVE_COMPARATOR

Abdominal Massage Therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Other Intervention Names

Abdominal Tuina Manipulation; Buspirone HCl

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sun Qing

OTHER

Sponsor Role: lead

Responsible Party

Sun Qing

deputy director of the Tuina Department

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jennifer Gao, Master

Role: CONTACT

jennifergao1982@126.com

022-27432929 ext. 13920595861

James Zhang, Master

Role: CONTACT

james399@126.com

022-27432929 ext. 13820590796

Facility Contacts

Qing Sun, Bachelor

Role: primary

gaoshuanger111@163.com

022-27432580 ext. 13820290606

Other Identifiers

TECF 20120210

Identifier Type: -

Identifier Source: org_study_id