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The Blinding Effect of a Sham-Controlled Setting: A Randomized Controlled Trial Among Healthy Individuals

The Blinding Effect of a Sham-Controlled Setting: A Randomized Controlled Trial Among Healthy Individuals

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025002330
Enrollment
Unknown
Registered
2025-11-28
Start date
2025-12-01
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Individuals

Interventions

Acupuncture group:Acupuncture
Sham acupuncture group:sham acupuncture

Sponsors

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Age 18-65 years, men or women; (2) Body mass index (BMI) 18.5–27.9 kg/m², without malnutrition, obesity, or obesity-related chronic conditions. (3) No acute or chronic organic or functional disorders that may interfere with the effect of study (e.g., chronic pain, hypertension), and no clinically significant abnormalities on physical examination. (4) No acupuncture treatment received within the past month. (5) Written informed consent provided.

Exclusion criteria

Exclusion criteria: (1) Contraindications to acupuncture, or history of severe acupuncture-related adverse events, such as significant coagulopathy, skin infection or severe dermatologic lesions, or severe vasovagal reactions. (2) Could not participate independently or difficulty in communication (e.g., severe psychiatric disorders, dementia, or illiteracy). (3) Prior participation in similar blinding assessment studies or being highly familiar with acupuncture trial designs (e.g., acupuncture professionals). (4) Women who are pregnant, breastfeeding, planning pregnancy, or of childbearing potential without effective contraception. (5) Suspected or confirmed history of alcohol or substance abuse.

Design outcomes

Primary

MeasureTime frame
James' Blinding Index;

Secondary

MeasureTime frame
Bang's Blinding Index;Deqi sensation;The sensation of insertion at acupoints;Blind selection agreement;Changes in pain threshold;

Countries

China

Contacts

Public ContactLiu Cun-Zhi

Beijing University of Chinese Medicine

lcz_tg@126.com15901261692

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026