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| Sponsor: | Ministry of Science and Technology of the People´s Republic of China |
|---|---|
| Information provided by: | Ministry of Science and Technology of the People´s Republic of China |
| ClinicalTrials.gov Identifier: | NCT00508482 |
Purpose
The purpose of this study is to re-evaluate the therapeutic superiority and safety of acupuncture treatment using high quality and large sampled clinical research. Our objectives are to normalize the syndrome differentiation, point selection, technical procedure, and electric acupuncture parameters, which provide high level evidence-based proofs for acupuncture clinical treatments. We want to provide a preferred treatment protocol, which is effective, safe, and easy to use in clinical practice. This research also clarifies that the insertion depth is a key factor in the therapeutic effect of acupuncture. The results of our study will help promote the development of the standardization of acupuncture.
| Condition | Intervention | Phase |
|---|---|---|
|
Constipation |
Device: Deep needle on ST25 (bilateral) with electric stimulator Drug: Lactulose Device: Huatuo brand needle, LH202H electric stimulator |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Clinical Standardization Study of the Preferred Acupuncture Treatment Protocol to Treat Functional Constipation |
| Estimated Enrollment: | 475 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
Deep needle on ST25 Tianshu (bilateral) with electric stimulator. Insert the needle (75 mm, Huatuo brand) vertically until it is 1 to 2mm into the peritoneum and the patient feels obvious dragging pain (which is about 1.8 to 2.5 cun) with no hand technique of the needle. Then put the electrode on the handle of the needle on both sides and the parameter is constant amplitude, 2/15Hz frequency, and the current intensity is adjusted to the abdominal muscles shiver slightly and the patient feels trivial pain. The abdomen circumference, the needle depth and the electric intensity of the first time treatment should be recorded as reference in the standardization.) Leave the needles for 30min. Once a day, five time a week, four weeks. |
Device: Deep needle on ST25 (bilateral) with electric stimulator
Huatuo brand needle (75mm, 30#), LH202H electric stimulator, parameter is constant wave, 2/15Hz, and current intensity is the abdominal muscles shiver slightly and the patient feels trivial pain. Once a day, five times a week, four weeks. |
|
B: Active Comparator
Lactulose oral solution, oral administration, 20-30ml The patient takes before breakfast. The treatment continues for four weeks.
|
Drug: Lactulose
20-30ml, before breakfast, and continues for four weeks
|
|
C
Acupuncture: ST-25 Tianshu (bilaterally), 25 mm filiform needle (Huatuo brand, 30#), vertically, depth: 0.3 cun (, or 7.5 mm); the acupuncture technique is superficial acupuncture and parameter of electric stimulator is the same as Group A. Course: once a day, five times a week, four weeks |
Device: Huatuo brand needle, LH202H electric stimulator
Huatuo brand needle (25 mm, 30#) Electric stimulator parameter is constant wave, 2/15Hz, the current intensity is the patient's abdominal muscles shiver slightly and the the patient feels trivial pain.
|
Functional constipation is a high morbidity disease. The life-long treatment of functional constipation can seriously impact a patient's quality of life. At present, the most frequently used treatment is catharsis, which deals with the symptom. This therapy is effective in the short-term for general functional constipation, whereas the effect is poor in colonic slow transit constipation. There are three main problems with catharsis. First, there are no long-lasting effects once the patient stops taking medication. Second, there are many side effects, including abdominal pain with defecation and diarrhea. Third, long-term use of irritant laxatives will not only make the constipation become refractory and complex; but also, this type of medicine can harm the enteric nervous system, cause melanosis coli, or even carcinoma of colon. Traditional Chinese Medicine diagnosis and treatment has its own advantages in treating functional constipation, but the therapeutic effect of treating colonic slow transit constipation is still uncertain. Although constipation is relieved to a certain extent, the patient also suffers from abdominal pain during defecation. Chinese herbs, such as Radix et Rhizoma Rhei, or Cassia angustifolia Vahl, are laxatives which also provide short-term effects. Long-term administration of the Chinese herbs will affect the regulation of Meissner's plexus, Auerbach's plexus, and gastrointestinal hormones, as well as make the digestive system depend on laxatives.
Therefore, a therapy that is safe with minimal side effects and good short-term and long-term effects is urgently needed in functional constipation treatment, especially for the type of slow colonic transit functional constipation.
Clinical practice shows that acupuncture meets this need. The acupuncture therapy is safe and effective especially for slow colonic transit functional constipation,and the therapeutic effects are still present several months after the treatment has been completed.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Zhishun Liu, M.D. | 8610-010-88001124 | liuzhishun@yahoo.com.cn |
| Contact: Jinna Yu, M.D. | 8610-010-88001413 | ayujinnaa@sina.com |
| China | |
| Guang'an Men Hospital Affiliated to China Academy of Chinese Medical Sciences | Recruiting |
| Beijing, China, 100053 | |
| Contact: Zhishun Liu, M.D. 8610-010-88001124 liuzhishun@yahoo.com.cn | |
| Contact: Jinna Yu, M.D. 8610-010-88001413 yujinnaa@sina.com | |
| Sub-Investigator: Jinna Yu, M.D. | |
| Study Director: | Zhishun Liu, M.D. | Guang'an Men Hospital Affiliated to China Academy of Chinese Medical Sciences |
More Information
| Responsible Party: | Guang'an Men Hospital Affiliated to China Academy of Chinese Medical Sciences ( Liu Zhishun, Chief of the Acupuncture Department, Guang'an Men Hospital ) |
| Study ID Numbers: | 2006BAI12B05-1 |
| Study First Received: | July 26, 2007 |
| Last Updated: | September 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00508482 History of Changes |
| Health Authority: | China: State Food and Drug Administration |
|
Acupuncture Functional constipation |
|
Signs and Symptoms Signs and Symptoms, Digestive Therapeutic Uses Gastrointestinal Agents |
Constipation Pharmacologic Actions Lactulose |