Condition category
Nervous System Diseases
Date applied
27/12/2013
Date assigned
17/02/2014
Last edited
17/02/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Diabetic peripheral neuropathy (DPN) is a common complication of diabetes, which may lead to diabetic foot ulcers and foot or limb amputations. It is commonly treated by acupuncture. There are many published cases reports showing that acupuncture works for DPN. More in-depth research is needed and this is the aim of this study (“Wentong Method” of “He’santong Method” based on “He’santong Method” developed by Professor He Puren).

Who can participate?
Participants diagnosed with DPN.

What does the study involve?
Participants are randomly allocated to one of two groups: “Wentong Method”/“He’santong Method” group or “Shallow acupuncture at sham points” group. Participants undergo a number of tests before and after the 8-week treatment.

What are the possible benefits and risks of participating?
Participants may experience infection, hematoma, syncope, discomfort after the acupuncture.

Where is the study run from?
BeiJing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University (China)

When is study starting and how long is it expected to run for?
August 2013 to July 2015.

Who is funding the study?
BeiJing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University (China)

Who is the main contact?
Professor Yi Jinghong
kycyjh@sina.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof Jinghong Yi

ORCID ID

Contact details

Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University
23 Mei Shu Guan Hou Jie
Dong Cheng District
Beijing
100010
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Effect of acupuncture using the He’Santong method on diabetic peripheral neuropathy: a randomised controlled trial

Acronym

Study hypothesis

1. The Wentong method and He’Santong method are both specific and holistic. This non-drug therapy has tremendous potential and is likely to treat diabetic peripheral neuropathy as expected.
2. Objective and comprehensive evaluating indexes can improve the credibility of acupuncture using the Wentong method and the He’Santong method” on diabetic peripheral neuropathy.

Ethics approval

Ethics Committee of Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, 29/11/2013, ref. 2013BL-085-01

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Diabetic Peripheral Neuropathy

Intervention

Patients are randomised to receive the following treatments:
1. Acupuncture using the Wentong method and the He’santong method
Main points: Yanglingquan, Zusanli, Taixi, Ashi points
Needling method: Wentong Method and He’Santong method
Treating course: treatment given twice a week for 8 weeks as one course of treatment
2.Shallow acupuncture at sham points
Points: sham meridians and points
Needling method: Shallow acupuncture at sham points
Treating course: treatment given twice a week for8 weeks as one course of treatment

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Traditional Chinese medicine (TCM) syndrome score at baseline, after treatment for 4 and 8 weeks, and after 4 weeks of completing the treatment
2. Nerve electrophysiological examination at baseline and after 8 weeks treatment

Secondary outcome measures

MDNS at baseline, after treatment for 4 and 8 weeks and after 4 weeks of completing the treatment

Overall trial start date

01/08/2013

Overall trial end date

31/07/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patient has diabetic peripheral neuropathy
2. Patient aged 18 to 70 years
3. Michigan diabetic neuropathy score (MDNS) of 7 to 29
4. Fasting blood glucose (FBG) less than or equal to 8.0mmol/L, Postprandial Plasma Glucose (PPG) less than or equal to 11.0 mmol/L
5. Patient providing informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Patient suffering from acute complications of diabetes within one month
2. Patients with spinal cord injury, spinal deformity, stroke sequela and neuromuscular disorders or peripheral neuropathy caused by other factors (such as heredity, alcoholism, uremia, infection, malnutrition, drug intoxication and metal intoxication)
3. Patient having epilepsy or mental illness
4. Patient having arteriovenous disease
5. Patient having the following complications: serious primary diseases of other systems, abnormal liver and kidney function, overwhelming infection or advanced tumor
6. Dipsomanias
7. Drug abuse over the past five years or been exposed to chemical poisons

Recruitment start date

01/08/2013

Recruitment end date

31/07/2015

Locations

Countries of recruitment

China

Trial participating centre

Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University
Beijing
100010
China

Sponsor information

Organisation

Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University (China)

Sponsor details

c/o Jinghong YI
23 Mei Shu Guan Hou Jie
Dong Cheng District
Beijing
100010
China

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University (China)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes