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CompletedNCT04188340Updated Dec 5, 2019

Effect of Su-Man Formula Massage Oil Acupressure on Sleep Quality and Anxiety in Patients With Insomnia

An interventional study of Su-Man formula massage oil in Insomnia, sponsored by China Medical University Hospital. Completed at 1 site in Taiwan. Open to female participants aged 20 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-05.

Sponsored by China Medical University Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
20 Years to 50 Years
Sex
Female
01

Study summary

The present study predict that Su-Man formula massage oil acupressure can improved sleep quality.

Read the detailed description

About 7% person in general population became as insomnia every year, and that has 30% person due to insomnia induces other symptoms such as anxiety. In addition, the incidence of insomnia in the female is 50% more than in the male. Insomnia belong to the scope of bù-mèi in traditional Chinese Medicine (TCM). TCM consider that the cause of insomnia is due to unbalance between yin and yang, and acupressure can treat insomnia. Several studies report that aromatherapy can enhance sleepy. Therefore, the purpose of the present study was to assess the therapeutic effect of Su-Man formula massage oil associates with acupressure on sleepy quality and anxiety lysis. A total 40 patients with insomnia divided into two groups, each group is 20 patients as follows: 1) control group, using bergamot massage oil apply to GV20, GV24 SP6, HT7 and PC6 acupoints, and massage for 10 times before sleep continuously 28 days; 2) test group, using Su-Man formula massage oil ap-ply to GV20, GV24, SP6, HT7 and PC6 acupoints, and massage for 10 times before sleep continuously 28 days. The primary outcome measurement is the Chinese version of Insomnia Severity In-dex(ISI-C), Pittsburgh Sleep Quality Index (CPSQI), and Beck Anxiety Inventory(BAI); The secondary outcome measure is the changes of meridian energy.

02

Conditions studied

  • Insomnia

Keywords

  • Su-Man formula massage oil
  • Acupressure
  • Meridian energy
  • Insomnia
03

In context

Sleep Initiation and Maintenance Disorders

1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.

This study's enrollment of 38 is below the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.

Browse Sleep Initiation and Maintenance Disorders studies →

Lead sponsor

China Medical University Hospital is the lead sponsor of 464 studies on the registry; 116 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • Women who has poor sleep status attaining a score of 5 on the Chinese Pittsburgh Sleep Quality Index
  • 20-50 years

Exclusion criteria

Exclusion Criteria:

  • having asthma or any diseases involving notable organ damage (e.g., heart, lungs, liver, or kidney failure or severe olfactory dysfunction)
  • being pregnant
  • being breastfeeding
  • have reached menopause
  • taking any medicine for improving sleep or anxiolytic drugs
  • be allergic to the oil that this study used.
  • having skin problem over the applying area,
  • having smoking and alchol drinking habit
  • inability to participate in the full course of the intervention courses
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
38 participants (actual)

Study arms

  • Placebo comparator
    control group

    using bergamot massage oil apply to GV20, GV24 SP6, HT7 and PC6 acupoints, and massage for 20 times before sleep continuously 28 days

    Behavioral: Su-Man formula massage oil

  • Experimental
    test group

    using Su-Man formula massage oil ap-ply to GV20, GV24, SP6, HT7 and PC6 acupoints, and massage for 20 times before sleep continuously 28 days

    Behavioral: Su-Man formula massage oil

Interventions

  • BehavioralSu-Man formula massage oil

    bergamot massage oil:dilute bergamot essential oil(0.5%) with almond oil Su-Man formula massage oil: mixed 4 different essential oil include bergamot, red mandarin, petit grain bigarade, spikenard and diluted with almond oil 5%.

    Also known as: bergamot massage oil

06

What researchers measure

Primary outcomes

  1. Chinese version of Pittsburgh Sleep Quality Index

    Evaluate the sleep quaility of participants

    Time frame: 5mins

Secondary outcomes

  1. M.E.A.D (Meridian Energy Analysis Device)

    The instrument mainly detects 24 representative points of the twelve meridians around the human body. The bioelectrical resistance of each meridian is measured by the test rod to evaluate the conductivity of each meridian, and the physiology of the subject is analyzed by computer. situation.

    Time frame: 10mins

  2. Chinese version of Insomnia Severity Index

    Evaluate the sleep quaility

    Time frame: 5mins

  3. Chinese version of Beck Anxiety Inventory

    measuring the severity of anxiety

    Time frame: 5mins

07

Study locations

1 site
  • ZEN chinese medicine clinic
    New Taipei City, 235, Taiwan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04188340
Lead sponsor
China Medical University Hospital
Responsible party
Sponsor
First posted
Dec 5, 2019
Start date
Apr 18, 2018
Primary completion
Apr 2, 2019
Completion
Apr 2, 2019
Last update
Dec 5, 2019

Study contacts

Ching-Liang Hsieh, PhD
principal investigator · China Medical University, China

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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