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Completed

NCT Number: NCT02822118

Therapeutic Effect of Chang'an I Recipe on Irritable Bowel Syndrome With Diarrhea

To evaluate the efficacy and safety of TCM decoction Chang'an I Recipe in the treatment of IBS-D. A multicenter, randomized, double-blind, placebo-controlled clinical trial was designed. Patients were applied for central random number and were given corresponding treatment according to inclusion sequences.The treatment group was administered the Chang'an I Recipe, 150ml/bag, 3 times/day; while the control group was administered the placebo, 150ml/bag, 3 times/day. Both courses of treatment were 8 weeks.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Dongzhimen Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients meeting the diagnostic criteria of Western medicine for IBS-D;
  • aged 18-70 years old; with a baseline IBS-SSS score over 75 points;
  • voluntarily signed the informed consent;
  • local resident who could ensure follow-ups, with basic reading ability.

Exclusion criteria

  • Patients with IBS-C, -M, and uncertain forms;
  • accompanied with serious lesions in major organs including heart, liver, and kidney, hematopoietic system diseases, and tumors;
  • gastrointestinal organic disease (e.g., chronic pancreatitis), or systemic diseases affecting the digestive tract motion (e.g., hyperthyroidism, diabetes, chronic renal insufficiency, and nervous system diseases);
  • undergoing or requiring constant use of drugs that may affect gastrointestinal functions (e.g., anti-cholinergic drugs, calcium channel blockers, 5-HT3 receptor antagonist, antidiarrheal agents, antacids, prokinetic agents, antidepressants, anxiolytics, and intestinal flora regulating drugs);
  • with history of abdominal surgery (e.g., cholecystectomy);
  • with an allergy history of tested drugs or severe allergy history of food;
  • pregnant and lactating female;
  • with a history of neurological or psychiatric disorders;
  • or participating in other clinical trial.

Treatment and study plan

Chang'an I Recipe

Drug

Patients in this group were administered the Chang'an I Recipe, 150ml/bag, 3 times/day for 8 weeks.

Other names: The treatment group

Placebo

Drug

Patients in this group were administered the placebo, 150ml/bag, times/day for 8 weeks.

Other names: The control group

Primary outcomes

  1. change of Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS)

    Time frame: IBS-SSS was evaluated by patients at 0, 2, 4 ,6 and 8 weeks.

    Score less than 75 points was considered as in remission, 75~175 as mild, 175~300 as moderate, and over 300 as severe.

Secondary outcomes

  1. Serum markers regarding liver and kidney function

    Time frame: at baseline and 8 weeks.

Sponsors and collaborators

Lead sponsor

Xiyuan Hospital of China Academy of Chinese Medical Sciences

Other

Registry information

Official study title

Therapeutic Effect of Chang'an I Recipe on Irritable Bowel Syndrome With Diarrhea: A Multicenter Randomized Double-Blind Placebo-Controlled Clinical Trial

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Jul 4, 2016
Registry last updated
Sep 5, 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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