Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100053, China
Location status: Recruiting
NCT Number: NCT06506240
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 108 patients diagnosed with SP in a 1:1 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.
Interested in participating?
Request Info60 year–80 year
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, 100053, China
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Participants aged between 60 and 80 years who meet diagnostic criteria for SP, with an average severity score of itching in the past week of ≥4 points on the Numerical Rating Scale (NRS), and who voluntarily provide written informed consent are eligible for inclusion.
Exclusion criteria
Participants will be excluded if they meet any of the following criteria:
Treatment will be administered by licensed practitioners with over five years of experience, in separate rooms to prevent patient interaction. The selected acupuncture points include LI11 (Quchi), SP10 (Xuehai), ST36 (Zusanli), SP6 (Sanyinjiao), LR3 (Taichong), LI4 (Hegu), ST25 (Tianshu), CV4 (Guanyuan), GV20 (Baihui), and superior GV29 (superior Yintang). Patients will receive acupuncture or sham acupuncture three times weekly for 6 weeks.
Time frame: Week 6
This will be assessed using weekly diaries for pruritus evaluation.
Time frame: Week 2, 4, 10, 14, and 18
Assessed through weekly diary of pruritus assessment
Time frame: Week 2, 4, 6, and week 10, 14, and 18
Assessed through weekly diary of pruritus assessment
Time frame: Week 2, 4, 6, and week 10, 14, and 18
Assessed through weekly diary of pruritus assessment
Time frame: Week 6, 10, 14, and 18
Measured using the Chinese Rule of Nine
Time frame: Week 6, 10, 14, and 18
ODS
Time frame: Week 6, 10, 14, and 18
Change from baseline in DLQI
Time frame: Week 6, and 18
Change from baseline in PSQI
Time frame: Week 6, and 18
Change from baseline in HADS
Time frame: Week 6, and 18
PGIC
Time frame: Week 0 to week 18
Adverse events
Contact information is provided by the study sponsor or research team.
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Other
Effects of Acupuncture for Senile Pruritus: Study Protocol for a Randomised Controlled Trial
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