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NCT07895550
The Effects of Manual Acupuncture on Superoxide Dismutase Enzyme Activity and Questionnaire of Smoking Urges-Brief Scores in Active Smokers: A Randomized Controlled Trial
Conditions: Superoxide Dismutase, Acupuncture
Sex: All
Ages: 21 Years – 40 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 44
Sponsor: Universitas Indonesia
Location: Universitas Indonesia Jakarta Pusat DKI Jakarta
Summary
The goal of this randomized, double-blind clinical trial is to evaluate the effects of a single session of manual acupuncture on superoxide dismutase (SOD) enzyme activity and smoking cravings in active smokers aged 21-40 years. The study will also examine the correlation between changes in SOD enzyme activity and changes in smoking cravings, as measured by the Questionnaire of Smoking Urges-Brief (QSU-Brief).
The main questions it aims to answer are:
1. Does a single session of manual acupuncture increase SOD enzyme activity, an indicator of antioxidant defense, 90 minutes after the intervention?
2. Does a single session of manual acupuncture reduce smoking cravings as measured by the Questionnaire of Smoking Urges-Brief (QSU-Brief)?
3. Is there a correlation between changes in SOD enzyme activity and changes in QSU-Brief scores?
Researchers will compare a manual acupuncture group with a sham acupuncture group to determine whether manual acupuncture produces greater changes in SOD enzyme activity and smoking cravings.
Participants will:
1. Be randomly assigned to receive either one 30-minute session of manual acupuncture or sham acupuncture.
2. Refrain from smoking for two hours before the intervention until the final blood sample is collected.
3. Undergo venous blood sampling before the intervention and 90 minutes after the intervention to measure SOD enzyme activity.
4. Complete the QSU-Brief questionnaire before and immediately after the intervention to assess changes in smoking cravings.
Eligibility Criteria
Inclusion Criteria:
* Male or female participants aged 21-40 years.
* Active smokers who have smoked at least 20 cigarettes per day for more than 5 years and meet the CDC definition of current smokers.
* Body Mass Index (BMI) between 18.5 and 29.9 kg/m².
* No previous experience with acupuncture treatment.
* Willing to participate in all study procedures and provide written informed consent.
* Able to communicate effectively and independently complete the study questionnaires.
Exclusion Criteria:
* Use of tobacco or nicotine products other than conventional cigarettes, including electronic cigarettes, vaping products, hand-rolled cigarettes, nicotine patches, or nicotine gum.
* Presence of fever or body temperature above 37.5°C.
* History of diagnosed chronic diseases, including autoimmune diseases, cancer, metabolic disorders, liver diseases, kidney diseases, pulmonary diseases, or cardiovascular diseases.
* Presence of skin lesions, wounds, tumors, or infections at the acupuncture sites.
* Hematological disorders or current use of anticoagulant medications.
* History of hypersensitivity to metals, particularly acupuncture needle materials.
* Currently undergoing pharmacological or non-pharmacological smoking cessation treatment.
* Use of antioxidant supplements within 4 weeks before the study.
* Use of anti-inflammatory medications within 2 weeks before the study.
Source: ClinicalTrials.gov (NCT07895550). StuddyBuddy aggregates publicly available trial information.