Completed

Efficacy of Acupuncture and Moxibustion Treatment in Patients With Active Crohn's Disease and Its Regulation Mechanism to the Immune Homeostasis Mediated by Th17/Treg Cells

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Treatment Group

+ Control Group

Other
Who is being recruted

Digestive System Diseases+3

+ Gastroenteritis

+ Gastrointestinal Diseases

From 18 to 70 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorShanghai Institute of Acupuncture, Moxibustion and Meridian
Last updated: November 20, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

The purpose of this study is to determine whether acupuncture or moxibustion therapies are effective in the treatment of active Crohn's disease. meanwhile, we are aim to observe the content of Inflammatory factors and Neurotransmitter before and after acupuncture and moxibustion therapy. Through treating active Crohn's disease by acupuncture and moxibustion therapies for 12 weeks, we are aim to observe the efficiency and the probably change of Inflammatory factors and Neurotransmitter of colonic mucosa and we may elucidate the mechanism of the efficiency of acupuncture and moxibustion therapy.

NCT01697761
Principal SponsorShanghai Institute of Acupuncture, Moxibustion and Meridian
Last updated: November 20, 2014
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

92 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 70 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

Digestive System DiseasesGastroenteritisGastrointestinal DiseasesIntestinal DiseasesInflammatory Bowel DiseasesCrohn Disease

Criteria

5 inclusion criteria required to participate
Crohn's Disease Activity Index [CDAI] > 150 and < 450
Not taking immunosuppressive agents or use " with " biological preparations within 3 months prior to entering the study
age 18-70 years
not taking any medication or taking salicylates, prednisone ( dose <= 15mg and at least have taken a month ), after entering the study the dose remained constant
Show More Criteria
5 exclusion criteria prevent from participating
Patients with other serious diseases
Severe Crohn's disease patients or patients in remission ( CDAI > 450 or < 150 )
The pregnancy or lactation period patients
The psychiatric patients
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
treat by moxibustion and acupuncture

Group II

Experimental
treat by Sham acupuncture and moxibustion

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

Shanghai Institute of Acupuncture-Moxibustion and Merdian

Shanghai, ChinaOpen Shanghai Institute of Acupuncture-Moxibustion and Merdian in Google Maps
CompletedOne Study Center