Senile PruritusNCT06506240
Effects of Acupuncture for Senile Pruritus
A study testing Acupuncture in people with Senile Pruritus, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Senile Pruritus
- What is being tested?
- Acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, 100053
He Chen, +86 19927523321, chenhenick@gmail.com
About this study
Official title: Effects of Acupuncture for Senile Pruritus: Study Protocol for a Randomised Controlled Trial
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.
- Conditions
- Senile Pruritus
- Being tested
- Acupuncture
- Keywords
- Acupuncture, Senile pruritus, Randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture group | Experimental | 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 , SP10, ST36, SP6, LR3, LI4, ST25, CV4, GV20, and superior GV29. Sterile disposable stainless-steel needles (0.3 mm×40 mm; Hwato brand, Suzhou Medical Appliance Factory, Suzhou, China) will be used. Patients will lie supine, and routine skin sterilization will be performed locally. Needles will be inserted at depths ranging from 10 to 30 mm at the designated acupuncture points. Each needle will be manually manipulated with lifting, thrusting, twirling, and rotating to elicit Deqi sensation (including soreness, numbness, distention, and heaviness). Needles will remain inserted for 30 minutes per session and manipulated three times, every 10 minutes. Acupuncture sessions will be conducted three times weekly over a six-week period. Receives: Other: Acupuncture |
| Sham acupuncture group | Sham comparator | Patients in the control group will undergo sham acupuncture using sterile disposable stainless-steel needles (0.3 mm×25 mm; Hwato brand, Suzhou Medical Appliance Factory, Suzhou, China). Needles will be inserted to depths of 2 to 3 mm at the same acupuncture points as in the acupuncture group. There will be no needle manipulation or attempt to induce Deqi sensation. Needles will be retained for 30 minutes per session. Receives: Other: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Numeric Rating Scale (NRS) scores for average itching severity at week 6.
This will be assessed using weekly diaries for pruritus evaluation.
Measured: Week 6
Secondary outcomes (9)
Change from baseline in NRS score for average itching severity
Assessed through weekly diary of pruritus assessment
Measured: Week 2, 4, 10, 14, and 18
Change from baseline in NRS score for maximum itching severity
Assessed through weekly diary of pruritus assessment
Measured: Week 2, 4, 6, and week 10, 14, and 18
Number of episodes of itching per day
Assessed through weekly diary of pruritus assessment
Measured: Week 2, 4, 6, and week 10, 14, and 18
Change from baseline in itchy area of the body surface
Measured using the Chinese Rule of Nine
Measured: Week 6, 10, 14, and 18
ODS
ODS
Measured: Week 6, 10, 14, and 18
Change from baseline in DLQI
Change from baseline in DLQI
Measured: Week 6, 10, 14, and 18
Change from baseline in PSQI
Change from baseline in PSQI
Measured: Week 6, and 18
Change from baseline in HADS
Change from baseline in HADS
Measured: Week 6, and 18
PGIC
PGIC
Measured: Week 6, and 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start1 Mar 2024
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Senile PruritusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This trial is a single-center, parallel-arm, randomized, sham-controlled clinical trial. Eligible participants are randomized and allocated to either the acupuncture or sham acupuncture groups at a 1:1 ratio.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, He Chen, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06506240
- Sponsor's protocol ID
- 2024-087-KY
- Status last verified
- Jul 2024
- First submitted
- 11 Jul 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol, statistical analysis plan, informed consent form (ICF) will be shared.
Publications
Chen H, Liu S, Gao S, Yi J, Shi H, Fang J, Wang W, Chen H, Liu Z. Effects and safety of acupuncture versus non-penetrating sham acupuncture for senile pruritus: Rationale and design for a randomized controlled trial. Contemp Clin Trials Commun. 2025 Feb 12;44:101454. doi: 10.1016/j.conctc.2025.101454. eCollection 2025 Apr.
PubMed 40027278
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Acupuncture for Senile Pruritus: Study Protocol for a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06506240
- Acronym / sponsor ID
- 2024-087-KY
- Conditions
- Senile Pruritus
- Keywords
- Acupuncture, Senile pruritus, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This trial is a single-center, parallel-arm, randomized, sham-controlled clinical trial. Eligible participants are randomized and allocated to either the acupuncture or sham acupuncture groups at a 1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Acupuncture group | Experimental | Other: AcupunctureTreatment 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 , SP10, ST36, SP6, LR3, LI4, ST25, CV4, GV20, and superior GV29. Sterile disposable stainless-steel needles (0.3 mm×40 mm; Hwato brand, Suzhou Medical Appliance Factory, Suzhou, China) will be used. Patients will lie supine, and routine skin sterilization will be performed locally. Needles will be inserted at depths ranging from 10 to 30 mm at the designated acupuncture points. Each needle will be manually manipulated with lifting, thrusting, twirling, and rotating to elicit Deqi sensation (including soreness, numbness, distention, and heaviness). Needles will remain inserted for 30 minutes per session and manipulated three times, every 10 minutes. Acupuncture sessions will be conducted three times weekly over a six-week period. |
| Sham acupuncture group | Sham comparator | Other: AcupuncturePatients in the control group will undergo sham acupuncture using sterile disposable stainless-steel needles (0.3 mm×25 mm; Hwato brand, Suzhou Medical Appliance Factory, Suzhou, China). Needles will be inserted to depths of 2 to 3 mm at the same acupuncture points as in the acupuncture group. There will be no needle manipulation or attempt to induce Deqi sensation. Needles will be retained for 30 minutes per session. |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcupunctureTreatment 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. | Other | Acupuncture group, Sham acupuncture group |
Primary outcome
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.
9 secondary outcomes
Change from baseline in NRS score for average itching severity
Time frame: Week 2, 4, 10, 14, and 18
Change from baseline in NRS score for maximum itching severity
Time frame: Week 2, 4, 6, and week 10, 14, and 18
Number of episodes of itching per day
Time frame: Week 2, 4, 6, and week 10, 14, and 18
Change from baseline in itchy area of the body surface
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, 10, 14, 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 6, and 18
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Derived from this study: PubMed 40027278Chen H, Liu S, Gao S, Yi J, Shi H, Fang J, Wang W, Chen H, Liu Z. Effects and safety of acupuncture versus non-penetrating sham acupuncture for senile pruritus: Rationale and design for a randomized controlled trial. Contemp Clin Trials Commun. 2025 Feb 12;44:101454. doi: 10.1016/j.conctc.2025.101454. eCollection 2025 Apr.
- Individual participant dataSharing planned: Yes. The study protocol, statistical analysis plan, informed consent form (ICF) will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Senile Pruritus, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact He Chen (+86 19927523321, chenhenick@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Numeric Rating Scale (NRS) scores for average itching severity at week 6. (time frame: Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06506240, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.