Acupuncture for Functional Constipation in Older Adults

Yin Ping

Status: Completed

Conditions: Constipation - Functional

Treatments: Device: sham acupuncture; Device: acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT05496543

21Y11923900

Details and patient eligibility

About

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".

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

84 participants in 2 patient groups, including a placebo group

Acupuncture group

Experimental group

Description:

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).

Treatment:

Device: acupuncture

Sham acupuncture group

Placebo Comparator group

Description:

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.

Treatment:

Device: sham acupuncture