Anxiety DisordersNCT02186366
Efficacy Study of Abdominal Massage Therapy to Treat Generalized Anxiety Disorder of Deficiency of Both Heart and Spleen Type
A study testing Abdominal Massage Therapy and Buspirone in people with Anxiety Disorders, run by Sun Qing at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders
- What is being tested?
- Abdominal Massage Therapy and Buspirone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- Sep 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, 300193
Qing Sun, Bachelor, 022-27432580 ext. 13820290606, gaoshuanger111@163.com
About this study
Official title: Study of Abdominal Massage Therapy for Generalized Anxiety Disorder Based on the " Essence Fosters Spirit " Theory
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.
Read the 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
- Being tested
- Abdominal Massage Therapy, Buspirone
- Keywords
- Anxiety Disorders, Massage Therapy, Treatment Efficacy
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abdominal Massage TherapyOther
Also called Abdominal Tuina Manipulation
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.
BuspironeDrug
Also called Buspirone HCl
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.
| Study group | Role | What they receive |
|---|---|---|
| Abdominal Massage Therapy | Experimental | Abdominal Massage Therapy , 30 minutes, three times one week for 6 weeks Receives: Drug: Buspirone |
| Buspirone | Active comparator | Buspirone by mouth 5mg three times per day for 6week Receives: Other: Abdominal Massage Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%
Measured: baseline and post- 6week intervention
Secondary outcomes (4)
Scores of Hamilton Depression Scale(HAMD)
We will estimate the scores of the Hamilton Depression Scale of participants.
Measured: baseline, post- 3week intervention, post- 6week intervention and post-3month after 6- week intervention
Scores of self-rating anxiety scale( SAS)
We will estimate the scores of the self-rating anxiety scale of participants.
Measured: 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.
Measured: 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.
Measured: post- 3week intervention and post- 6week intervention and post-3month after 6- week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Qing
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sun Qing, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02186366
- Sponsor's protocol ID
- TECF 20120210
- Status last verified
- Sep 2014
- First submitted
- 23 Jun 2014
- Last updated
- 3 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Abdominal Massage Therapy for Generalized Anxiety Disorder Based on the " Essence Fosters Spirit " Theory
- ClinicalTrials.gov ID
- NCT02186366
- Acronym / sponsor ID
- TECF 20120210
- Conditions
- Anxiety Disorders
- Keywords
- Anxiety Disorders, Massage Therapy, Treatment Efficacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Sun QingUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Oct 2015 (estimated)
- First posted
- 10 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abdominal Massage Therapy | Experimental | Drug: BuspironeAbdominal Massage Therapy , 30 minutes, three times one week for 6 weeks |
| Buspirone | Active comparator | Other: Abdominal Massage TherapyBuspirone by mouth 5mg three times per day for 6week |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abdominal Massage TherapyAlso: Abdominal Tuina ManipulationAbdominal 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 | Buspirone |
| BuspironeAlso: Buspirone HClBuspirone 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. | Drug | Abdominal Massage Therapy |
Primary outcome
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%
4 secondary outcomes
Scores of Hamilton Depression Scale(HAMD)
Time frame: baseline, post- 3week intervention, post- 6week intervention and post-3month after 6- week intervention
Scores of self-rating anxiety scale( SAS)
Time frame: baseline, post- 3week intervention, post- 6week intervention and post-3month after 6- week intervention
Scores of Quality of life assessment scale
Time frame: baseline, post- 3week intervention, post- 6week intervention and post-3month after 6- week intervention
Scores of Clinical Global Impression
Time frame: post- 3week intervention and post- 6week intervention and post-3month after 6- week intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abdominal Massage Therapy and Buspirone in people with Anxiety Disorders, run by Sun Qing at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jennifer Gao, Master (022-27432929 ext. 13920595861, jennifergao1982@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
reductive rate of Hamilton Depression Scale（ HAMD reductive rate） (time frame: baseline and post- 6week intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2014.