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NCT Number: NCT06506240

Effects of Acupuncture for Senile Pruritus

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.

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Key information

Conditions

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100053, China

Location status: Recruiting

Location contact

Who can participate

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:

  • Severe skin damage or infection;
  • Severe underlying diseases including cardiovascular diseases, hepatobiliary diseases, kidney diseases, hematologic diseases, autoimmune diseases, infectious diseases, severe malnutrition, or malignancies;
  • Mental illness, cognitive dysfunction, or language disorders;
  • Received acupuncture therapy for pruritus within the past month;
  • Have a history of drug abuse.

Treatment and study plan

Acupuncture

Other

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.

Primary outcomes

  1. Change from baseline in Numeric Rating Scale (NRS) scores for average itching severity at week 6.

    Time frame: Week 6

    This will be assessed using weekly diaries for pruritus evaluation.

Secondary outcomes

  1. Change from baseline in NRS score for average itching severity

    Time frame: Week 2, 4, 10, 14, and 18

    Assessed through weekly diary of pruritus assessment

  2. Change from baseline in NRS score for maximum itching severity

    Time frame: Week 2, 4, 6, and week 10, 14, and 18

    Assessed through weekly diary of pruritus assessment

  3. Number of episodes of itching per day

    Time frame: Week 2, 4, 6, and week 10, 14, and 18

    Assessed through weekly diary of pruritus assessment

  4. Change from baseline in itchy area of the body surface

    Time frame: Week 6, 10, 14, and 18

    Measured using the Chinese Rule of Nine

  5. ODS

    Time frame: Week 6, 10, 14, and 18

    ODS

  6. Change from baseline in DLQI

    Time frame: Week 6, 10, 14, and 18

    Change from baseline in DLQI

  7. Change from baseline in PSQI

    Time frame: Week 6, and 18

    Change from baseline in PSQI

  8. Change from baseline in HADS

    Time frame: Week 6, and 18

    Change from baseline in HADS

  9. PGIC

    Time frame: Week 6, and 18

    PGIC

Other outcomes

  1. Adverse events

    Time frame: Week 0 to week 18

    Adverse events

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Other

Registry information

Official study title

Effects of Acupuncture for Senile Pruritus: Study Protocol for a Randomised Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 17, 2024
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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