NCT06390761 Efficacy of Acupuncture for the Treatment of Parkinson's Disease Related Constipation
| NCT ID | NCT06390761 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xi'an No.3 Hospital |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-04-30 |
| Primary Completion | 2027-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-04-30 with a primary completion date of 2027-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of the study is to evaluate the efficacy of acupuncture in treating Parkinson's disease related constipation (PDC). In the randomized controlled clinical trial study, patients meeting the criteria for inclusion will be randomly enrolled and divided into two groups in a 1:1 ratio: the acupuncture group and the sham acupuncture group. The intervention is going to be executed using the acupoints EX-HN1（Sishencong),LI4 (Hegu),ST25 (Tianshu),ST37(Shangjuxu),ST36(Zusanli),ST44 (Neiting), ST44 (Taichong), SP6 (Sanyinjiao) and CV4 (Shuangyuan).The acupuncture needles will be inserted to a depth of 0.8 to 1 cm in the acupuncture group. The sham acupuncture group's needles will be inserted to a depth of 0.2 to 0.3 cm with nonacupuncture points located 0.5 cm in lateral to the real acupoint or to the right for midline points. During the study, researchers will observe changes in complete spontaneous bowel movements (CSBMs), Constipation Symptom and Efficacy Assessment Scale (CSEAS) (including the six dimensions of difficulty, Bristol, time, incompleteness, frequency,and bloating), the Patient-Assessment of Constipation Quality of Life questionnaire (PAC-QOL), and the Unified Parkinson's Disease Rating Scale (UPDRS) at baseline (week 0), post-treatment (week 4), and follow-up (week 12).Colonic transit time measurement and conventional anorectal manometry were evaluated at the above time points.
Eligibility Criteria
Inclusion Criteria: 1. A diagnosis of PD (according to the Movement Disorder Society's revised clinical diagnostic criteria for Parkinson's disease in 2015) and functional constipation (according to the Rome IV diagnostic criteria) ; 2. Age between 35 and 80 years; 3. Hoehn-Yahr grade ≤ 3; 4. No medications taken within 2 weeks that may affect gastrointestinal function (such as prucalopride and probiotics); 5. No anticipation in other clinical trials within 1 month; 6. Voluntary engagement in this study, ability to sign the informed consent, and cooperation in the completion of the bowel diary and scale filling. Exclusion Criteria: 1. Organic lesions of the digestive system (such as intestinal adhesions, obstructions, tumors, or malformations in the gastrointestinal tract); 2. A history of abdominal or anorectal surgery that may affect intestinal transit, systemic diseases that may affect the dynamics of the digestive tract (such as diabetes and hyperthyroidism); 3. Serious life-threatening diseases (such as severe cardiovascular diseases and malignant tumors); 4. Skin lesions that were inappropriate for needling, the viscose allergy that prevented acupuncture device attachment; 5. Pregnant or lactating women.
Contact & Investigator
Gejuan Zhang, Doctor
STUDY DIRECTOR
The dean
Frequently Asked Questions
Who can join the NCT06390761 clinical trial?
This trial is open to participants of all sexes, aged 35 Years or older, up to 80 Years, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06390761 currently recruiting?
Yes, NCT06390761 is actively recruiting participants. Contact the research team at zhanggejuan@163.com for enrollment information.
Where is the NCT06390761 trial being conducted?
This trial is being conducted at Xi'an, China.
Who is sponsoring the NCT06390761 clinical trial?
NCT06390761 is sponsored by Xi'an No.3 Hospital. The principal investigator is Gejuan Zhang, Doctor at The dean. The trial plans to enroll 60 participants.
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