Condition category
Digestive System
Date applied
18/11/2011
Date assigned
09/12/2011
Last edited
23/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Ulcerative colitis is a long-term condition where the colon and rectum become inflamed. The colon is the large intestine (bowel), and the rectum is the end of the bowel where stools are stored. Corticosteroids such as dexamethasone are a type of medication used to reduce the inflammation. They can be administered orally (by mouth) or through a suppository or enema (into the rectum). Xilei-san is a traditional Chinese herbal medicine. Recently a study showed that Xilei-san was effective at treating ulcerative proctitis (a mild form of ulcerative colitis). The aim of this study is to compare a rectal Xilei-san enema with a conventional steroid enema in the treatment of patients with mild or moderate ulcerative proctitis.

Who can participate?
Patients aged 18 to 80 with ulcerative proctitis

What does the study involve?
Participants undergo a colonoscopy, where a flexible tube containing a camera is used to examine the colon and assess the severity of their condition. Participants are then randomly allocated to be treated with either dexamethasone or Xilei-San enemas. They are assessed again at week 4, 8 and 20.

What are the possible benefits and risks of participating?
Participants may benefit from a decrease in the severity of their condition. Participants may suffer from an allergic reaction, and the symptoms are joint pain, muscle pain, fever, rash and discomfort.

Where is the study run from?
First Affiliated Hospital of Zhengzhou University (China)

When is the study starting and how long is it expected to run for?
August 2010 to August 2011

Who is funding the study?
1. Research fund for the Doctoral Program of Higher Education of China (China)
2. The Youth Innovation Fund of the First Affiliated Hospital of Zhengzhou University (China)

Who is the main contact?
Dr Fangbin Zhang

Trial website

Contact information

Type

Scientific

Primary contact

Dr Fangbin Zhang

ORCID ID

Contact details

40 Daxue Road
Zhengzhou
450052
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A Chinese herbal medicine (Xilei-san) for mild/moderate ulcerative proctitis: a randomised, placebo controlled study

Acronym

Study hypothesis

Xilei-san enema is effective in the treatment of mild to moderate ulcerative proctitis (UP)

Ethics approval

First Affiliated Hospital of Zhengzhou University, 01/08/2010, ref: 20100801GS-7

Study design

Randomised placebo-controlled single-centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Mild or moderate ulcerative proctitis

Intervention

Dexamethasone was formulated as 5 mg/60 ml and Xilei-San as 1000 mg/60 ml (Beijing Tong Ren Tang Ltd., Co., Beijing, China). Patients were instructed to take the formulation as enema once a day for 4 weeks and monitored the usage of drug and the compliance of patients by weekly clinic visit. Only those patients attaining clinical response were recruited in the second stage treatment.

In the second stage treatment, dexamethasone was formulated as 2 mg/60 ml. Patients in group I were received rectal preparation once a day for 2 weeks, followed by once every 2 days for 1 week, and once every 3 days for 1 week, then discontinue the dexamethasone therapy for 12 weeks. Patients in group II were received the same dosage of rectal Xilei-San preparation once a day for 4 weeks, then discontinued the Xilei-San therapy for 12 weeks.

All patients were assigned to be administered oral mesalazine 1000 mg (Etiasa, Ferring, Ipsen, Germany) 3 times a day as the foundation treatment and not allowed to use other medicine during the whole trial.

Patients were enrolled consecutively following a medical evaluation of the initial clinical and endoscopic severity of the condition using full colonoscopy. They were evaluated at inclusion, and at week 4, 8 and 20. Colonoscopy was done by the same gastroenterologist and all biopsy specimens were studied by the same experienced pathologist.

Clinical severity of the disease was determined according to the refined criteria of Marteau considering the major clinical manifestations of mild to moderate UP was rectal bleeding, but not obvious systemic symptoms. Remission was defined as a score = 0, and last 3 times fecal occult blood test was negative within the last 1 week. Improvement was defined as a decrease in the score by 2 points from baseline. Partial improvement was defined as a decrease in the score by 2 points from baseline and sum score > 2 points. Non-improvement was defined as a decrease in the score by < 2 points from baseline or an increase in the score. Clinical relapse was evaluated in patients attaining clinical response and remission at week 8, and was defined as occurrence of bloody stools and positive fecal occult blood test >2 times in last 12 weeks.

Endoscopic severity of the disease was determined according to mucosa appearance: 0 = normal; 1 = erythema, reduced capillary network, mild friability, minimal granularity; 2 = friability, marked erythema, no vascularisation, erosions, pus; 3 = ulceration, spontaneous bleeding, pus; Three categories for endoscopic response were: remission, a score = 0; response, a decrease in the score by 1 point from baseline; no response, similar or aggravated endoscopic finding compared with baseline.

Histological severity of the disease was determined according to the criteria of Truelove & Richards.: 0 = no significant Inflammation; 1 = mild inflammation; 2 = moderate inflammation; 3 = severe inflammation.

Intervention type

Drug

Phase

Not Applicable

Drug names

Herbal medicine (Xilei-san)

Primary outcome measures

Clinical remission rate at week 4

Secondary outcome measures

1. Clinical and endoscopic remission rates at week 8
2. Clinical relapse rates at week 20
3. Adverse events were assessed at week 4, 8 and 20

Overall trial start date

01/08/2011

Overall trial end date

01/08/2011

Reason abandoned

Eligibility

Participant inclusion criteria

Patients between the ages of 18 and 80 years were eligible to participate if they had previously established UP with mild to moderate exacerbation at least 7 days

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Xilei-san group: 18; Conventional steroid group: 17

Participant exclusion criteria

1. Patients receiving 5-aminosalicylic acid and/or immunosuppressive agents in 7 days prior to entry into the trial, except those suffering symptomatic relapse during maintenance treatment of oral 5-aminosalicylic acid (5-ASA) preparations
2. Patients currently or recently receiving any oral or rectal steroid preparation
3. Patients having any episode of drug allergy and
4. Pregnant or lactating women

Recruitment start date

01/08/2011

Recruitment end date

01/08/2011

Locations

Countries of recruitment

China

Trial participating centre

Zhengzhou University
Zhengzhou
450052
China

Sponsor information

Organisation

Zhengzhou University (China)

Sponsor details

40 Daxue Road
Zhengzhou
450052
China

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Research fund for the Doctoral Program of Higher Education of China (China)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Youth Innovation Fund of the First Affiliated Hospital of Zhengzhou University (China)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

23/09/2016: Plain English summary added.