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Completed

NCT Number: NCT02084186

Moxibustion for Mild and Moderate Ulcerative Colitis

The purpose of this study is to determine whether moxibustion is effective to mild and moderate ulcerative colitis and the effect of moxibustion on metabolism.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Institute of Acupuncture-Moxibustion and Meridian

Shanghai, 200030, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meet the diagnosis of UC
  • Mayo ≤10
  • Patients should have never received any pharmacological therapy or if they are receiving aminosalicylates and/or prednisolone (the dosage has been taken at least 4 weeks, and should be kept the same as before throughout the trial)
  • Patients should have never received antibiotic, biologicals, probiotics, acetaminophen, acetamide and contraceptive.
  • A written informed consent

Exclusion criteria

  • Patients with cardiac, encephalic, hepatic, nephric, hematopoietic system, psychotic or any other serious diseases
  • Pregnancy or lactation

Treatment and study plan

herb-partitioned moxibustion

Other

Ignited moxa cones are placed upon herbal cake. Herbs are smashed into powder. Every 2.8g medicine powder mix with 3g millet wine and then be pressed into herbal cakes which are 28mm in diameter and 7mm in high with a specific mould. Then the herbal cake with a moxa cone will be fixed on Tianshu and Shangjuxu.

bran-partitioned moxibustion

Other

Ignited moxa cones are placed upon bran cake. Every 2.8g bran powder mix with 3g millet wine and then be pressed into bran cakes which are 28mm in diameter and 7mm in high with a specific mould. Then the bran cake with a moxa cone will be fixed on Tianshu and Shangjuxu.

Primary outcomes

  1. disease activity index (DAI)

    Time frame: 3 months

    Using Mayo subscore

Secondary outcomes

  1. Inflammatory Bowel Disease Questionnaire (IBDQ)

    Time frame: 3 months

  2. symptom score

    Time frame: 3 months

  3. histomorphology observation of intestinal mucosa

    Time frame: 3 months

    Using the Geboes histology score

  4. metabolic profile of intestinal mucosa, urine, plasma and serum

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Shanghai Institute of Acupuncture, Moxibustion and Meridian

Other

Registry information

Official study title

The Mechanism of Moxibustion in Treating Ulcerative Colitis Based on Metabonomics

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 11, 2014
Registry last updated
Oct 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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