Intradialytic Nausea and VomitingNCT07888777
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
A study testing Acupuncture in people with Intradialytic Nausea and Vomiting and Chronic Kidney Disease, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
This study aims to evaluate the immediate effects of acupuncture therapy at three specific acupuncture points (PC6, ST36, and KI3) on intradialysis nausea and vomiting in patients with chronic kidney disease undergoing regular hemodialysis. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Intradialytic Nausea and Vomiting, Chronic Kidney Disease, Acupuncture
- What is being tested?
- Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteIndonesia
- Study dates
- Nov 2026to 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 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with chronic kidney disease (CKD) who experience intradialytic nausea and vomiting, undergo routine hemodialysis twice weekly for at least 6 months, and are hemodynamically stable.
- Subjects aged 18-59 years.
- Subjects who have not received acupuncture therapy within at least one month prior to the study.
- Subjects who are willing to participate in the study according to the scheduled protocol until completion and who have signed the informed consent form.
Who cannot join
- Subjects with malignancies or infected wounds at the acupuncture point sites intended for intervention.
- Subjects with primary skin diseases, such as allergic dermatitis, irritant contact dermatitis, neurodermatitis, and psoriasis.
- Subjects with a history of hypersensitivity reactions to previous acupuncture therapy, including stainless steel allergy, atopy, keloid formation, or other hypersensitivity reactions.
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
Anthonius S Rulie, MD, +6285942085155, anthoniusrulie@gmail.com
About this study
Official title: The Effect of Manual Acupuncture on Intradialytic Nausea and Vomiting Scores in Patients With Chronic Kidney Disease Undergoing Routine Hemodialysis: A Randomized Controlled Trial
This study aims to evaluate the immediate effects of acupuncture therapy at three specific acupuncture points (PC6, ST36, and KI3) on intradialysis nausea and vomiting in patients with chronic kidney disease undergoing regular hemodialysis. The outcome will be assessed using the Rhodes Index of Nausea, Vomiting, and Retching (RINVR) score one hour during the treatment and two hours after completion of hemodialysis.
- Being tested
- Acupuncture, sham acupuncture
- Medical subject headings
- Vomiting, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureDevice
The manual acupuncture is using sterile Huanqiu® needles
sham acupunctureDevice
The sham acupuncture using blunt-tipped needles
| Study group | Role | What they receive |
|---|---|---|
| Manual Acupuncture | Experimental | Manual acupuncture is performed at bilateral PC6 (Neiguan), ST36 (Zusanli), and KI3 (Taixi) using sterile Huanqiu® needles (0.25 × 25 mm) inserted 20 mm deep through a hole in a transparent waterproof Onemed® plaster, guided by a 20-mm tube. Needles are retained for 20 minutes without manipulation and then removed, twice per treatment period. Sample are blindfolded during the procedure. Device: Manual Acupuncture The manual acupuncture is using sterile Huanqiu® needles Receives: Device: Acupuncture |
| Sham Acupuncture | Sham comparator | Manual acupuncture is performed at bilateral PC6 (Neiguan), ST36 (Zusanli), and KI3 (Taixi) using with blunt-tipped needles that only press against an intact plaster without penetrating the skin above the Onemed® plaster, pressed by a 20-mm tube, controlling for pressure sensation and expectation. Sample are blindfolded during the procedure.
Device: Sham Acupuncture The sham acupuncture using blunt-tipped needles Receives: Device: sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rhodes Index of Nausea, Vomiting and Retching (RINVR)
Measured: baseline (after dialysis is running for 1 hour), 2 hours after dialysis is finished
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intradialytic Nausea and VomitingStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthonius Santoso Rulie, Universitas Indonesia
- Investigators
- Medical Acupuncture Study Program FKUI, Principal investigator, Medical Acupuncture Study Program Faculty of Medicine Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07888777
- Sponsor's protocol ID
- 0328/EC/KEPK/09/2026_
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Manual Acupuncture on Intradialytic Nausea and Vomiting Scores in Patients With Chronic Kidney Disease Undergoing Routine Hemodialysis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07888777
- Acronym / sponsor ID
- 0328/EC/KEPK/09/2026_
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 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.
This study aims to evaluate the immediate effects of acupuncture therapy at three specific acupuncture points (PC6, ST36, and KI3) on intradialysis nausea and vomiting in patients with chronic kidney disease undergoing regular hemodialysis. The outcome will be assessed using the Rhodes Index of Nausea, Vomiting, and Retching (RINVR) score one hour during the treatment and two hours after completion of hemodialysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual Acupuncture | Experimental | Device: AcupunctureManual acupuncture is performed at bilateral PC6 (Neiguan), ST36 (Zusanli), and KI3 (Taixi) using sterile Huanqiu® needles (0.25 × 25 mm) inserted 20 mm deep through a hole in a transparent waterproof Onemed® plaster, guided by a 20-mm tube. Needles are retained for 20 minutes without manipulation and then removed, twice per treatment period. Sample are blindfolded during the procedure. Device: Manual Acupuncture The manual acupuncture is using sterile Huanqiu® needles |
| Sham Acupuncture | Sham comparator | Device: sham acupunctureManual acupuncture is performed at bilateral PC6 (Neiguan), ST36 (Zusanli), and KI3 (Taixi) using with blunt-tipped needles that only press against an intact plaster without penetrating the skin above the Onemed® plaster, pressed by a 20-mm tube, controlling for pressure sensation and expectation. Sample are blindfolded during the procedure. Device: Sham Acupuncture The sham acupuncture using blunt-tipped needles |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients with chronic kidney disease (CKD) who experience intradialytic nausea and vomiting, undergo routine hemodialysis twice weekly for at least 6 months, and are hemodynamically stable.
- Subjects aged 18-59 years.
- Subjects who have not received acupuncture therapy within at least one month prior to the study.
- Subjects who are willing to participate in the study according to the scheduled protocol until completion and who have signed the informed consent form.
Key exclusion criteria (3 listed)
- Subjects with malignancies or infected wounds at the acupuncture point sites intended for intervention.
- Subjects with primary skin diseases, such as allergic dermatitis, irritant contact dermatitis, neurodermatitis, and psoriasis.
- Subjects with a history of hypersensitivity reactions to previous acupuncture therapy, including stainless steel allergy, atopy, keloid formation, or other hypersensitivity reactions.
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 |
|---|---|---|
| AcupunctureThe manual acupuncture is using sterile Huanqiu® needles | Device | Manual Acupuncture |
| sham acupunctureThe sham acupuncture using blunt-tipped needles | Device | Sham Acupuncture |
Primary outcome
Rhodes Index of Nausea, Vomiting and Retching (RINVR)
Time frame: baseline (after dialysis is running for 1 hour), 2 hours after dialysis is finished
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 5 Nov 2026.
- Individual participant dataSharing planned: No
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.
Medical Acupuncture Study Program FKUI principal investigator
Medical Acupuncture Study Program Faculty of Medicine Universitas Indonesia
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 Intradialytic Nausea and Vomiting and Chronic Kidney Disease, 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 4 inclusion and 3 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 5 Nov 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 Anthonius S Rulie, MD (+6285942085155, anthoniusrulie@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rhodes Index of Nausea, Vomiting and Retching (RINVR) (time frame: baseline (after dialysis is running for 1 hour), 2 hours after dialysis is finished). 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 5 Nov 2026.