Completed

Warm Needling Moxibustion at Tianshu and Guanyuan Acupoints for Yang Deficiency Type Chronic Functional Constipation

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Study Aim

This study aims to treat Yang Deficiency type chronic functional constipation by using warm needling moxibustion at Tianshu and Guanyuan acupoints, with the primary goal of improving your Constipation Severity Score (CSS) at week 4 and month 6.

What is being tested

Warm Needling

+ Electroacupuncture

Device
Who is being recruted

Pathologic Processes

+ Pathological Conditions, Signs and Symptoms

+ Yang Deficiency

From 18 to 65 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: August 2022
See protocol details

Summary

Principal SponsorThe First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Last updated: March 20, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2022

Actual date on which the first participant was enrolled.

Chronic functional constipation (FC) is a common condition that can negatively impact quality of life, often associated with psychological issues like anxiety and depression. A specific type within Traditional Chinese Medicine (TCM) is 'Yang deficiency type' FC, which is understood as a deficiency of Yang Qi leading to slowed metabolism and weakened large intestine motility. This study explores whether warm needling moxibustion at specific acupoints, Tianshu (ST25) and Guanyuan (CV4), can provide superior and sustained benefits compared to electroacupuncture alone for this condition. The trial aims to offer clinical evidence on the efficacy of warm needling for a well-defined TCM condition, potentially improving care for those suffering from chronic functional constipation. This single-center, randomized controlled trial involves 60 participants diagnosed with Yang deficiency type chronic FC. Participants are divided into two groups: an experimental group receiving warm needling, and a control group receiving electroacupuncture. For the warm needling group, sterile needles are inserted at Tianshu (ST25) and Guanyuan (CV4), then a moxa stick is attached and ignited, conducting heat down the needle to deeper tissues. For the electroacupuncture group, needle insertion is identical, but the needles are connected to an electroacupuncture device delivering a dense-sparse wave. Both groups receive treatment every other day, three times weekly, for four weeks. The primary outcome is the change from baseline in the Constipation Severity Score (CSS) at week 4 and month 6, with secondary outcomes including changes in TCM syndrome score, Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS), and Patient Assessment of Constipation Quality of Life (PAC-QOL) scale.

Official TitleA Clinical Study on Warm Needling Moxibustion at Tianshu and Guanyuan Acupoints
NCT07483229
Principal SponsorThe First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Last updated: March 20, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Pathologic ProcessesPathological Conditions, Signs and SymptomsYang Deficiency

Criteria

6 inclusion criteria required to participate
Age 18 to 65 years, either sex

Meeting the Rome IV diagnostic criteria for functional constipation

Meeting the Traditional Chinese Medicine diagnostic criteria for Yang deficiency type constipation

No other treatments received before inclusion

Show More Criteria

5 exclusion criteria prevent from participating
Inability to receive abdominal acupuncture due to skin diseases or other local conditions

Not meeting the inclusion criteria

Pregnant or lactating women

Serious cardiovascular or cerebrovascular diseases

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants receive warm needling therapy at Tianshu (ST25) and Guanyuan (CV4) acupoints. After achieving deqi (needling sensation) with standard acupuncture needles (0.25×40mm), a moxa stick (2cm diameter, 3cm length) is ignited and attached to the needle handle, providing combined thermal and acupoint stimulation for 30 minutes per session. Treatment is administered every other day, three times weekly, for a total of four weeks.

Group II

Active Comparator
Participants receive electroacupuncture at Tianshu (ST25) and Guanyuan (CV4) acupoints. After achieving deqi with standard acupuncture needles (0.25×40mm), needle handles are connected to an electroacupuncture device (Hwato SDZ-V series) delivering a dense-sparse wave (2/15 Hz) at an intensity sufficient to produce mild muscle twitching. Needles are retained for 30 minutes per session. Treatment is administered every other day, three times weekly, for a total of four weeks.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

the First Affiliated Hospital of Henan University of Chinese Medicine

Zhengzhou, ChinaOpen the First Affiliated Hospital of Henan University of Chinese Medicine in Google Maps
CompletedOne Study Center