Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02186366
Recruitment Status : Unknown
Verified September 2014 by Sun Qing, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine.
Recruitment status was:  Recruiting
First Posted : July 10, 2014
Last Update Posted : September 3, 2014
Sponsor:
Information provided by (Responsible Party):
Sun Qing, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

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.


Condition or disease Intervention/treatment Phase
Anxiety Disorders Other: Abdominal Massage Therapy Drug: Buspirone Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of Abdominal Massage Therapy for Generalized Anxiety Disorder Based on the " Essence Fosters Spirit " Theory
Study Start Date : September 2014
Estimated Primary Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Abdominal Massage Therapy
Abdominal Massage Therapy , 30 minutes, three times one week for 6 weeks
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.
Other Name: Buspirone HCl

Active Comparator: Buspirone
Buspirone by mouth 5mg three times per day for 6week
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.
Other Name: Abdominal Tuina Manipulation




Primary Outcome Measures :
  1. reductive rate of Hamilton Depression Scale( HAMD reductive rate) [ Time Frame: baseline and post- 6week intervention ]
    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%


Secondary Outcome Measures :
  1. Scores of Hamilton Depression Scale(HAMD) [ Time Frame: baseline, post- 3week intervention, post- 6week intervention and post-3month after 6- week intervention ]
    We will estimate the scores of the Hamilton Depression Scale of participants.

  2. Scores of self-rating anxiety scale( SAS) [ Time Frame: baseline, post- 3week intervention, post- 6week intervention and post-3month after 6- week intervention ]
    We will estimate the scores of the self-rating anxiety scale of participants.

  3. Scores of Quality of life assessment scale [ Time Frame: baseline, post- 3week intervention, post- 6week intervention and post-3month after 6- week intervention ]
    We will estimate the scores of the Quality of life assessment scale of participants.

  4. Scores of Clinical Global Impression [ Time Frame: post- 3week intervention and post- 6week intervention and post-3month after 6- week intervention ]
    We will estimate the scores of Clinical Global Impression.


Other Outcome Measures:
  1. content of 5-HT in blood plasma [ Time Frame: baseline and post- 6week intervention ]
    We will test the content of 5-HT of participants in blood plasma and record the data.

  2. content of Norepinephrine in blood plasma [ Time Frame: baseline and post- 6week intervention ]
    We will test the content of Norepinephrine of participants in blood plasma and record the data.

  3. content of total cortisol in blood plasma [ Time Frame: baseline and post- 6week intervention ]
    We will test the content of total cortisol of participants in blood plasma and record the data.

  4. blood stream speed of MCA, ACA, PCA and BA [ Time Frame: baseline and post- 6week intervention ]
    We will test blood stream speed of MCA, ACA, PCA and BA of patients by Transcranial Doppler and record the data.

  5. vascular resistance index of MCA, ACA, PCA and BA [ Time Frame: baseline and post- 6week intervention ]
    We will test vascular resistance index of MCA, ACA, PCA and BA of patients by Transcranial Doppler and record the data.

  6. pulsatility index of MCA, ACA, PCA and BA [ Time Frame: baseline and post- 6week intervention ]
    We will test pulsatility index of MCA, ACA, PCA and BA of patients by Transcranial Doppler and record the data.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02186366


Contacts
Layout table for location contacts
Contact: Jennifer Gao, Master 022-27432929 ext 13920595861 jennifergao1982@126.com
Contact: James Zhang, Master 022-27432929 ext 13820590796 james399@126.com

Locations
Layout table for location information
China, Tianjin
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine Recruiting
Tianjin, Tianjin, China, 300193
Contact: Qing Sun, Bachelor    022-27432580 ext 13820290606    gaoshuanger111@163.com   
Sponsors and Collaborators
Sun Qing

Layout table for additonal information
Responsible Party: Sun Qing, deputy director of the Tuina Department, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT02186366     History of Changes
Other Study ID Numbers: TECF 20120210
First Posted: July 10, 2014    Key Record Dates
Last Update Posted: September 3, 2014
Last Verified: September 2014
Keywords provided by Sun Qing, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine:
Anxiety Disorders, Massage Therapy, Treatment Efficacy
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Anxiety Disorders
Pathologic Processes
Mental Disorders
Buspirone
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action