Superoxide DismutaseNCT07895550
The Effects of Manual Acupuncture on Superoxide Dismutase Enzyme Activity and Questionnaire of Smoking Urges-Brief Scores in Active Smokers: A Randomized Controlled Trial
A study testing Acupuncture in people with Superoxide Dismutase and Acupuncture, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Superoxide Dismutase, Acupuncture
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteIndonesia
- Study dates
- 23 Nov 2026to 21 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site
Universitas Indonesia
Jakarta Pusat, DKI Jakarta, 10430
Teresa Nadia Marpaung, MD, +6281299086328, teresa.nadia@ui.ac.id
About this study
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:
Read more
- Does a single session of manual acupuncture increase SOD enzyme activity, an indicator of antioxidant defense, 90 minutes after the intervention?
- Does a single session of manual acupuncture reduce smoking cravings as measured by the Questionnaire of Smoking Urges-Brief (QSU-Brief)?
- 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:
- Be randomly assigned to receive either one 30-minute session of manual acupuncture or sham acupuncture.
- Refrain from smoking for two hours before the intervention until the final blood sample is collected.
- Undergo venous blood sampling before the intervention and 90 minutes after the intervention to measure SOD enzyme activity.
- Complete the QSU-Brief questionnaire before and immediately after the intervention to assess changes in smoking cravings.
- Conditions
- Superoxide Dismutase, Acupuncture
- Being tested
- Acupuncture, Sham Acupuncture
- Keywords
- Manual Acupuncture, Superoxide Dismutase, Oxidative Stress, QSU-Brief
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
Participants will receive a single 30-minute session of manual acupuncture at GV20 and bilateral ST36, SP6, and HT7 using sterile acupuncture needles (0.25 × 25 mm) with the Park Sham Needle Device.
Sham AcupunctureProcedure or surgery
Participants will receive a single 30-minute session of sham acupuncture at GV20 and bilateral ST36, SP6, and HT7 using the Park Sham Needle Device. Blunt, non-penetrating needles will be positioned at the same acupoints as the manual acupuncture group without penetrating the skin.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants will receive a single 30-minute session of manual acupuncture Receives: Procedure: Acupuncture |
| Control Group | Sham comparator | Participants will receive a single 30-minute session of non-penetrating sham manual acupuncture Receives: Procedure: Sham Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Superoxide Dismutase (SOD) Enzyme Activity
Superoxide dismutase (SOD) enzyme activity will be measured from venous blood samples collected before and 90 minutes after the intervention using an enzyme-linked immunosorbent assay (ELISA). SOD activity will be expressed in U/gHb (units per gram of hemoglobin). Changes in SOD activity from baseline will be compared between the manual acupuncture and sham acupuncture groups.
Measured: Baseline (before intervention) and 90 minutes after completion of the intervention.
Secondary outcomes (1)
Change in Questionnaire of Smoking Urges-Brief (QSU-Brief) Score
Smoking cravings will be assessed using the Questionnaire of Smoking Urges-Brief (QSU-Brief), a 10-item questionnaire rated on a 7-point Likert scale. Total scores range from 10 to 70, with higher scores indicating greater smoking cravings. The questionnaire will be completed before and immediately after the intervention. Changes in QSU-Brief scores from baseline will be compared between the manual acupuncture and sham acupuncture groups.
Measured: Baseline (before intervention) and immediately after completion of the 30-minute intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start23 Nov 2026 (estimated)
- Primary completion14 Dec 2026 (estimated)
- Study completion21 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Superoxide DismutaseStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either the intervention group receiving a single 30-minute session of manual acupuncture or the control group receiving sham acupuncture. Outcomes will be assessed by measuring superoxide dismutase (SOD) enzyme activity before and 90 minutes after the intervention, and smoking cravings using the Questionnaire of Smoking Urges-Brief (QSU-Brief) before and immediately after the intervention.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teresa Nadia Renasari, Universitas Indonesia
- Investigators
- KPEK FKUI-RSCM, Principal investigator, Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07895550
- Sponsor's protocol ID
- 26-10-1524
- Status last verified
- Oct 2026
- First submitted
- 17 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data (IPD) with other researchers. Study findings will be reported in aggregate form without disclosing participants' identities.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Manual Acupuncture on Superoxide Dismutase Enzyme Activity and Questionnaire of Smoking Urges-Brief Scores in Active Smokers: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07895550
- Acronym / sponsor ID
- 26-10-1524
- Conditions
- Superoxide Dismutase, Acupuncture
- Keywords
- Manual Acupuncture, Superoxide Dismutase, Oxidative Stress, QSU-Brief
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 23 Nov 2026 (estimated)
- Primary completion
- 14 Dec 2026 (estimated)
- Study completion
- 21 Dec 2026 (estimated)
- First posted
- 26 Oct 2026 (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.
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:
- Does a single session of manual acupuncture increase SOD enzyme activity, an indicator of antioxidant defense, 90 minutes after the intervention?
- Does a single session of manual acupuncture reduce smoking cravings as measured by the Questionnaire of Smoking Urges-Brief (QSU-Brief)?
- 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:
- Be randomly assigned to receive either one 30-minute session of manual acupuncture or sham acupuncture.
- Refrain from smoking for two hours before the intervention until the final blood sample is collected.
- Undergo venous blood sampling before the intervention and 90 minutes after the intervention to measure SOD enzyme activity.
- Complete the QSU-Brief questionnaire before and immediately after the intervention to assess changes in smoking cravings.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either the intervention group receiving a single 30-minute session of manual acupuncture or the control group receiving sham acupuncture. Outcomes will be assessed by measuring superoxide dismutase (SOD) enzyme activity before and 90 minutes after the intervention, and smoking cravings using the Questionnaire of Smoking Urges-Brief (QSU-Brief) before and immediately after the intervention.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Procedure: AcupunctureParticipants will receive a single 30-minute session of manual acupuncture |
| Control Group | Sham comparator | Procedure: Sham AcupunctureParticipants will receive a single 30-minute session of non-penetrating sham manual acupuncture |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| AcupunctureParticipants will receive a single 30-minute session of manual acupuncture at GV20 and bilateral ST36, SP6, and HT7 using sterile acupuncture needles (0.25 × 25 mm) with the Park Sham Needle Device. | Procedure or surgery | Intervention Group |
| Sham AcupunctureParticipants will receive a single 30-minute session of sham acupuncture at GV20 and bilateral ST36, SP6, and HT7 using the Park Sham Needle Device. Blunt, non-penetrating needles will be positioned at the same acupoints as the manual acupuncture group without penetrating the skin. | Procedure or surgery | Control Group |
Primary outcome
Change in Superoxide Dismutase (SOD) Enzyme Activity
Time frame: Baseline (before intervention) and 90 minutes after completion of the intervention.
Superoxide dismutase (SOD) enzyme activity will be measured from venous blood samples collected before and 90 minutes after the intervention using an enzyme-linked immunosorbent assay (ELISA). SOD activity will be expressed in U/gHb (units per gram of hemoglobin). Changes in SOD activity from baseline will be compared between the manual acupuncture and sham acupuncture groups.
1 secondary outcome
Change in Questionnaire of Smoking Urges-Brief (QSU-Brief) Score
Time frame: Baseline (before intervention) and immediately after completion of the 30-minute intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data (IPD) with other researchers. Study findings will be reported in aggregate form without disclosing participants' identities.
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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.
KPEK FKUI-RSCM principal investigator
Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital
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 Superoxide Dismutase and Acupuncture, run by Universitas Indonesia at 1 site in Indonesia.
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 6 inclusion and 9 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: opening soon, as of the sponsor's last update on 26 Oct 2026. 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 Indonesia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Teresa Nadia Marpaung, MD (+6281299086328, teresa.nadia@ui.ac.id), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Superoxide Dismutase (SOD) Enzyme Activity (time frame: Baseline (before intervention) and 90 minutes after completion of the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2026.