Constipation - FunctionalNCT05496543

Acupuncture for Functional Constipation in Older Adults

A study testing acupuncture in people with Constipation - Functional, run by Yin Ping at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Through a scientific and standardized randomized controlled study, we observe the effectiveness and safety of acupuncture in the treatment of functional constipation in the elderly through the method of "nourishing kidney and dredging Fu organs". Read more about this study

Who is it for?: Ages 60 to 80 years
Conditions the study is for: Constipation - Functional
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: 84 participants
Where: 1 siteChina
Study dates: 10 Oct 2022to 30 Sep 2024
Phase: Interventional
Are there results?: None posted in the registry

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 60 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Meet Rome IV Diagnostic Criteria for Constipation and TCM Diagnostic Criteria of constipation with yin deficiency syndrome;
No gender restriction, age 60-80;
FC that is classified as mild or moderate;
Have not used any medicine for constipation at least 2 weeks before treatment (except emergency treatment);
Have not participated in other medical clinical trials over the past one month;
Those who can understand various evaluation scales, complete the evaluation and cooperate with the completion of the planned course of treatment;
Sign the informed consent.

Who cannot join

Irritable bowel syndrome and constipation caused by tumors, inflammatory reactions, endocrine and metabolic diseases, and drugs;
Constipation caused by organic diseases;
Patients with serious primary diseases such as heart, brain, liver, kidney and hematopoietic system, infectious diseases, tumors, and mental diseases;
Those who voluntarily give up or cannot cooperate with treatment and observation due to various circumstances;
Patients with cognitive impairment or aphasia;
Those who take other drugs during treatment, which affect the efficacy and judgment (except emergency treatment).

Trial locations and contacts

1 site in 1 country.

China1 site

Longhua Hospital
Shanghai, 200032

Other trials in China

About this study

Official title: A Randomized Controlled Clinical Trial of Acupuncture in Nourishing Kidney and Dredging Fu Organs for Functional Constipation in Older Adults

Read the detailed description

Functional constipation is a common disease of old people. To date, there has not specific therapy on it. Former research showed acupuncture may work for functional constipation. In the trial, patients in the acupuncture and sham acupuncture groups will receive 24 acupuncture treatments over an 8-week period. This RCT is designed to confirm the efficacy and safety of acupuncture in functional constipation treatment.

Conditions: Constipation - Functional
Being tested: acupuncture, sham acupuncture

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

acupunctureDevice
All acupoints will be routinely sterilized at first. After the insertion of the needles, manipulations of lifting, twirling, and thrusting are performed on all needles to reach de qi, which is a sensation typically associated with needling including soreness, numbness, swelling, heaviness, and other feelings. This is considered to be an important component of the therapeutic effect of acupuncture.
sham acupunctureDevice
The placebo needles chosen for this study are flat-tipped needles without a tip, which could not be pierced into the skin. In the meanwhile, an external patch device will fix the needles, which are visually pierced into the skin. After the treatment, the acupuncturist will press the acupuncture point with a dry cotton ball so that the patient can feel the pulling out of the "needle".

Study groups in NCT05496543
Study group	Role	What they receive
Acupuncture group	Experimental	Participants will receive acupuncture treatment at Zhao Hai(KI 6), Da Zhong(KI 4), Tai Xi(KI 3), Tian Shu(ST 25), and Shang Ju Xu(ST 37) bilaterally. Each treatment will last 30 minutes and participants will receive the treatment 3 times per week (every other day) for 8 weeks, 24 sessions in total. Follow-up time is week 4 and week 12 after treatment (ie, week 12 and week 20). Receives: Device: acupuncture
Sham acupuncture group	Placebo comparator	Participants will receive sham acupuncture treatment on bilateral sham Zhao Hai(KI 6), Da Zhong(KI 4), Tai Xi(KI 3), Tian Shu(ST 25), and Shang Ju Xu(ST 37) that match real acupuncture points. The duration of needle retention, treatment period, and follow-up in the control group is the same as that in the intervention group. Receives: Device: sham acupuncture

What is being measured

The primary outcome is the main question the study is designed to answer.

The change in the mean number of CSBMs per week compared to baseline during the 8-week treatment period
Complete Spontaneous Bowel Movements (CSBMs) refers to the frequency of a bowel movement that occurred in the absence of laxatives or manipulation.
Measured: At baseline, week 4 (in treatment), week 8 (end of treatment), and the follow-up period (week 12 and week 20 after randomization).

Secondary outcomes (7)

Bristol Stool Scale
A scale to classify the patient's voluntary bowel movement stool.
Measured: At baseline and at week 8 (end of treatment).
Patient Assessment of Constipation-Symptoms (PAC-SYM)
A scale to assess the condition of the patient's constipation-related symptoms
Measured: At baseline and at week 8 (end of treatment).
Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL)
A brief but comprehensive assessment of the daily life quality of patients with FC, containing 28 items
Measured: At baseline and at week 8 (end of treatment).
Self-rating Anxiety Scale（SAS）
A measure of somatic symptoms associated with anxiety reactions.
Measured: At baseline and at week 8 (end of treatment).
Self-rating Depression Scale（SDS）
A self-rating scale to assess patients' depression
Measured: At baseline and at week 8 (end of treatment).
Weekly usage of emergency bowel medications
The proportions of participants using medications and doses for emergency treatment
Measured: At baseline and at week 8 (end of treatment).
Incidence of adverse events
The adverse events (AEs) assessment aims at evaluating the AEs of acupuncture treatment.
Measured: During 1-8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Oct 202230 Sep 2024

First posted11 Aug 2022
Study start10 Oct 2022
Primary completion1 Mar 2024
Study completion30 Sep 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Constipation - FunctionalStudies of the same condition, open and under way.
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: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05496543
Sponsor's protocol ID: 21Y11923900
Status last verified: May 2025
First submitted: 9 Aug 2022
Last updated: 22 May 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Zhou K, Fang J, Wang X, Wang Y, Hong Y, Liu J, Wang L, Xue C, Wang P, Liu B, Zhu B. Characterization of de qi with electroacupuncture at acupoints with different properties. J Altern Complement Med. 2011 Nov;17(11):1007-13. doi: 10.1089/acm.2010.0652. Epub 2011 Oct 14.
PubMed 21999154
Dunstan DA, Scott N. Norms for Zung's Self-rating Anxiety Scale. BMC Psychiatry. 2020 Feb 28;20(1):90. doi: 10.1186/s12888-019-2427-6.
PubMed 32111187
Dunstan DA, Scott N. Clarification of the cut-off score for Zung's self-rating depression scale. BMC Psychiatry. 2019 Jun 11;19(1):177. doi: 10.1186/s12888-019-2161-0.
PubMed 31185948

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
Recruiting
Effects of Connective Tissue Massage Plus Biofeedback for Dyssynergic Defecation
Dyssynergic Defecation
RecruitingObservational study
Relationship Between Interoception and Postural Control in Constipation-Predominant Irritable Bowel Syndrome
Constipation, Irritable Bowel Disease
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation

All Constipation - Functional trials

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Clinical Trial of Acupuncture in Nourishing Kidney and Dredging Fu Organs for Functional Constipation in Older Adults
ClinicalTrials.gov ID: NCT05496543
Acronym / sponsor ID: 21Y11923900
Conditions: Constipation - Functional
Study type: Interventional
Recruitment status: Completed
Enrolment: 84 participants (actual)
Lead sponsor: Yin PingUniversity, hospital or other
Collaborators: Shanghai Municipal Hospital of Traditional Chinese Medicine, Longhua Hospital
Study start: 10 Oct 2022 (actual)
Primary completion: 1 Mar 2024 (actual)
Study completion: 30 Sep 2024 (actual)
First posted: 11 Aug 2022 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Acupuncture group	Experimental	Device: acupunctureParticipants will receive acupuncture treatment at Zhao Hai(KI 6), Da Zhong(KI 4), Tai Xi(KI 3), Tian Shu(ST 25), and Shang Ju Xu(ST 37) bilaterally. Each treatment will last 30 minutes and participants will receive the treatment 3 times per week (every other day) for 8 weeks, 24 sessions in total. Follow-up time is week 4 and week 12 after treatment (ie, week 12 and week 20).
Sham acupuncture group	Placebo comparator	Device: sham acupunctureParticipants will receive sham acupuncture treatment on bilateral sham Zhao Hai(KI 6), Da Zhong(KI 4), Tai Xi(KI 3), Tian Shu(ST 25), and Shang Ju Xu(ST 37) that match real acupuncture points. The duration of needle retention, treatment period, and follow-up in the control group is the same as that in the intervention group.

Who may qualify

Ages: 60 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Meet Rome IV Diagnostic Criteria for Constipation and TCM Diagnostic Criteria of constipation with yin deficiency syndrome;
No gender restriction, age 60-80;
FC that is classified as mild or moderate;
Have not used any medicine for constipation at least 2 weeks before treatment (except emergency treatment);
Have not participated in other medical clinical trials over the past one month;

Key exclusion criteria (6 listed)

Irritable bowel syndrome and constipation caused by tumors, inflammatory reactions, endocrine and metabolic diseases, and drugs;
Constipation caused by organic diseases;
Patients with serious primary diseases such as heart, brain, liver, kidney and hematopoietic system, infectious diseases, tumors, and mental diseases;
Those who voluntarily give up or cannot cooperate with treatment and observation due to various circumstances;
Patients with cognitive impairment or aphasia;

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
acupunctureAll acupoints will be routinely sterilized at first. After the insertion of the needles, manipulations of lifting, twirling, and thrusting are performed on all needles to reach de qi, which is a sensation typically associated with needling including soreness, numbness, swelling, heaviness, and other feelings. This is considered to be an important component of the therapeutic effect of acupuncture.	Device	Acupuncture group
sham acupunctureThe placebo needles chosen for this study are flat-tipped needles without a tip, which could not be pierced into the skin. In the meanwhile, an external patch device will fix the needles, which are visually pierced into the skin. After the treatment, the acupuncturist will press the acupuncture point with a dry cotton ball so that the patient can feel the pulling out of the "needle".	Device	Sham acupuncture group

Primary outcome

The change in the mean number of CSBMs per week compared to baseline during the 8-week treatment period
Time frame: At baseline, week 4 (in treatment), week 8 (end of treatment), and the follow-up period (week 12 and week 20 after randomization).
Complete Spontaneous Bowel Movements (CSBMs) refers to the frequency of a bowel movement that occurred in the absence of laxatives or manipulation.

7 secondary outcomes

Bristol Stool Scale
Time frame: At baseline and at week 8 (end of treatment).
Patient Assessment of Constipation-Symptoms (PAC-SYM)
Time frame: At baseline and at week 8 (end of treatment).
Patient Assessment of Constipation Quality of Life Questionnaire (PAC-QOL)
Time frame: At baseline and at week 8 (end of treatment).
Self-rating Anxiety Scale（SAS）
Time frame: At baseline and at week 8 (end of treatment).
Self-rating Depression Scale（SDS）
Time frame: At baseline and at week 8 (end of treatment).
Weekly usage of emergency bowel medications
Time frame: At baseline and at week 8 (end of treatment).
Incidence of adverse events
Time frame: During 1-8 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
Background: PubMed 21999154Zhou K, Fang J, Wang X, Wang Y, Hong Y, Liu J, Wang L, Xue C, Wang P, Liu B, Zhu B. Characterization of de qi with electroacupuncture at acupoints with different properties. J Altern Complement Med. 2011 Nov;17(11):1007-13. doi: 10.1089/acm.2010.0652. Epub 2011 Oct 14.
Background: PubMed 32111187Dunstan DA, Scott N. Norms for Zung's Self-rating Anxiety Scale. BMC Psychiatry. 2020 Feb 28;20(1):90. doi: 10.1186/s12888-019-2427-6.
Background: PubMed 31185948Dunstan DA, Scott N. Clarification of the cut-off score for Zung's self-rating depression scale. BMC Psychiatry. 2019 Jun 11;19(1):177. doi: 10.1186/s12888-019-2161-0.
Individual participant dataSharing planned: No

Related trials for Constipation - Functional

Active, not recruitingPhase 2
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-based Treatment Groups of Plecanatide Versus Placebo in Children and Adolescent Participants 6 to Less Than 18 Years of Age With FC
Functional Constipation (FC)
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
Recruiting
Effects of Connective Tissue Massage Plus Biofeedback for Dyssynergic Defecation
Dyssynergic Defecation
RecruitingObservational study
Relationship Between Interoception and Postural Control in Constipation-Predominant Irritable Bowel Syndrome
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RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
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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. This study is not recruiting at the moment.

PING YIN principal investigator

Shanghai University of Traditional Chinese Medicine

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 Constipation - Functional, run by Yin Ping at 1 site in China.

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 7 inclusion and 6 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: finished, as of the sponsor's last update on 22 May 2025. 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 China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change in the mean number of CSBMs per week compared to baseline during the 8-week treatment period (time frame: At baseline, week 4 (in treatment), week 8 (end of treatment), and the follow-up period (week 12 and week 20 after randomization).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05496543, which also lists 3 linked publications.

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 22 May 2025.