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Not yet recruitingNCT07895550Updated Oct 26, 2026

The Effects of Manual Acupuncture on Superoxide Dismutase Enzyme Activity and Questionnaire of Smoking Urges-Brief Scores in Active Smokers: A Randomized Controlled Trial

An interventional study of Acupuncture and Sham Acupuncture in Superoxide Dismutase and Acupuncture, sponsored by Universitas Indonesia. Not yet recruiting at 1 site in Indonesia. Open to participants aged 21 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by Universitas Indonesia · Not applicable, Interventional, and Basic science

Updated Oct 26, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
21 Years to 40 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Superoxide Dismutase
  • Acupuncture

Keywords

  • Manual Acupuncture
  • Superoxide Dismutase
  • Oxidative Stress
  • QSU-Brief
03

In context

Lead sponsor

Universitas Indonesia is the lead sponsor of 29 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
44 participants (estimated)

Study arms

  • Experimental
    Intervention Group

    Participants will receive a single 30-minute session of manual acupuncture

    Procedure: Acupuncture

  • Sham comparator
    Control Group

    Participants will receive a single 30-minute session of non-penetrating sham manual acupuncture

    Procedure: Sham Acupuncture

Interventions

  • ProcedureAcupuncture

    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.

  • ProcedureSham Acupuncture

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: Baseline (before intervention) and immediately after completion of the 30-minute intervention.

07

Study locations

1 site
  • Universitas Indonesia
    Jakarta Pusat, DKI Jakarta 10430, Indonesia
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07895550
Lead sponsor
Universitas Indonesia
Responsible party
Teresa Nadia Renasari (MD, Universitas Indonesia) — Principal investigator
First posted
Oct 26, 2026
Start date
Nov 23, 2026 (estimated)
Primary completion
Dec 14, 2026 (estimated)
Completion
Dec 21, 2026 (estimated)
Last update
Oct 26, 2026

Study contacts

Teresa Nadia Marpaung, MD
Contact
teresa.nadia@ui.ac.id
+6281299086328
KPEK FKUI-RSCM
principal investigator · Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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