Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:14 AM
Ignite Modification Date:
2025-12-25 @ 1:14 AM
NCT ID:
NCT05863793
Eligibility Criteria:
Inclusion Criteria:
* 1\. Aged 18-75 years (either sex)
* Patients who meet diagnosis of DPN defined by ADA in 2005：a. DPN is defined as the presence of symptoms and/or signs of peripheral nerve dysfunction in people with diabetes, after the exclusion of other causes. b. NP is defined as altered sensitivity to pressure and (1) altered sensitivity to pain or (2) altered sensitivity to vibration or (3) achilles reflex.
* Symmetric and predominantly sensory, starting from the lower limbs distally and gradually spreading proximally in a glove-and-stocking distribution.
* Ability to understand study procedures and willingness to comply with them for the entire period of study.
* Written informed consent
Exclusion Criteria:
* PN caused by conditions other than diabetes (e.g.,alcohol abuse, chemotherapy, hereditary causes, chronic inflammatory, or idiopathic PN)
* Psychiatric illnesses other than mild depression.
* Severe or unstable cardiovascular, liver, kidney, respiratory, or hematological disorders.
* Received acupuncture treatment in the last 3 months.
* Pregnant or lactating women.
* Research unit personnel directly related to the study and their immediate family members.
* Incapable of giving informed consent or following the study instructions due to language disturbances, serious cognitive deficits, or lack of time.
* Currently participating in other clinical trials.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05863793
Study Brief:
Protocol Section:
NCT05863793