Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06506240
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Effects of Acupuncture for Senile Pruritus
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Acupuncture for Senile Pruritus Study Protocol for a Randomised Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Senile pruritus SP characterized by idiopathic itching in individuals aged 60 years and older without primary skin lesions significantly impacts sleep and quality of life Effective alternative treatments are needed Acupuncture has been suggested as a potential intervention to alleviate itching however its role in managing SP remains uncertain This study aims to evaluate the effects and safety of acupuncture for SP This single-centre parallel two-arm randomized sham-controlled trial will enroll 64 patients diagnosed with SP in a 11 ratio to either the acupuncture or sham acupuncture group Participants outcome assessors and the statistician will be blinded Treatment will consist of 18 sessions over 6 weeks The primary outcome is change from baseline in the Numerical Rating Scale NRS score for average itching severity at week 6 assessed weekly via weekly diary of pruritus assessment Secondary outcomes include changes in NRS score for maximum itching severity daily episodes of itching itchy area of body surface overall dry skin score ODS the Dermatology Life Quality Index DLQI the Pittsburgh Sleep Quality Index PSQI the Hospital Anxiety and Depression Scale HADS and Patient Global Impression of Change PGIC Adverse events will be monitored throughout the study period The intention-to-treat ITT population will include participants who complete baseline assessments and receive at least one treatment session
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None