Effects of Acupuncture for Senile Pruritus

Last updated: November 18, 2024
Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hives (Urticaria)

Skin Wounds

Rash

Treatment

Acupuncture

Clinical Study ID

NCT06506240
2024-087-KY
  • Ages 60-80
  • All Genders

Study 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 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

Participants will be excluded if they meet any of the following criteria:

  1. Severe skin damage or infection;

  2. Severe underlying diseases including cardiovascular diseases, hepatobiliarydiseases, kidney diseases, hematologic diseases, autoimmune diseases, infectiousdiseases, severe malnutrition, or malignancies;

  3. Mental illness, cognitive dysfunction, or language disorders;

  4. Received acupuncture therapy for pruritus within the past month;

  5. Have a history of drug abuse.

Study Design

Total Participants: 108
Treatment Group(s): 1
Primary Treatment: Acupuncture
Phase:
Study Start date:
March 01, 2024
Estimated Completion Date:
February 28, 2026

Connect with a study center

  • Guang'anmen Hospital, China Academy of Chinese Medical Sciences

    Beijing, Beijing 100053
    China

    Active - Recruiting

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