- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07451353
Short-term Comparative Clinical Outcomes of Acupuncture and Phototherapy in Chronic Generalized Pruritus
Short-term Comparative Clinical Outcomes of Acupuncture and Phototherapy in Chronic Generalized Pruritus: A Prospective Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
None Selected
-
Ankara, None Selected, Turkey (Türkiye), 06630
- Nermin KARAOSMANOĞLU
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 18 years
- Clinical diagnosis of chronic generalized pruritus lasting longer than 6 weeks
- Ability to understand the study procedures and provide written informed consent
- Willingness to comply with the study protocol and attend scheduled visits
Exclusion Criteria (Acupuncture Group):
- Pregnancy or breastfeeding
- Bleeding disorders or use of anticoagulant therapy
- Skin diseases or lesions impairing skin integrity at acupuncture application sites
- Advanced hypertension or heart failure
Exclusion Criteria (Phototherapy Group):
- Pregnancy or breastfeeding
- Sun hypersensitivity or photodermatoses
- Skin diseases triggered by sunlight
- Claustrophobia
- Advanced hypertension or heart failure
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Acupunture
Patients received acupuncture treatment twice weekly for one month (total of eight sessions).
Sterile disposable steel needles (0.25 × 25 mm) were applied at standardized acupuncture points: LI11 (Quchi), LI4 (Hegu), ST36 (Zusanli), SP4 (Gongsun), SP6 (Sanyinjiao), SP10 (Xuehai), GB31 (Fengshi), LU10 (Yuji), PC6 (Neiguan), and DU20 (Baihui).
Each session lasted 30 minutes, with manual stimulation performed every 10 minutes until the Deqi sensation was achieved.
|
Sterile disposable stainless steel acupuncture needles (0.25 × 25 mm) were used for acupuncture treatment.
|
|
Active Comparator: Narrow-band UVB Phototherapy
Patients underwent narrow-band UVB phototherapy three times per week for one month.
Treatment doses ranged between 3.6 and 5.34 J/cm², adjusted according to individual skin type.
|
Patients underwent narrow-band UVB phototherapy three times per week for one month.
Narrowband UVB therapy was administered using a licensed NB-UVB phototherapy unit.
Treatment doses ranged between 3.6 and 5.34 J/cm², adjusted according to individual skin type.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Visual Analogue Scale for Pruritus
Time Frame: Baseline to 1 month
|
The Visual Analogue Scale (VAS) is a patient-reported scale used to assess pruritus severity. Unit of Measure: Units on a Scale Scale Description : Visual Analogue Scale ranges from 0 to 10, where 0 indicates no pruritus and 10 indicates the worst imaginable pruritus. Higher scores indicate worse pruritus severity. |
Baseline to 1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Investigator's Global Assessment for Chronic Pruritus
Time Frame: Baseline to 1 month
|
Investigator's Global Assessment (IGA) is a clinician-rated scale assessing disease severity in patients with chronic pruritus. Unit of Measure: Units on a Scale Scale Description: Investigator's Global Assessment scores range from 0 to 4, where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe disease. Higher scores indicate worse disease severity. |
Baseline to 1 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2024/15
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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