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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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5 January 2021 |
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Main ID: |
ISRCTN18291857 |
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Date of registration:
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25/10/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The clinical study of pasting "Wei Tan Wai Fu Fang" on acupuncture point to treat patients suffering postoperative gastroparesis of digestive cancer
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Scientific title:
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The clinical study of pasting "Wei Tan Wai Fu Fang" on acupuncture point to treat patients suffering postoperative gastroparesis of digestive cancer: a double-blind randomised parallel group multi-site trial |
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Date of first enrolment:
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01/07/2013 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN18291857 |
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Study type:
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Interventional |
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Study design:
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Double-blind randomised parallel-group multi-site trial (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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China
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Hu
Kaiwen |
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Address:
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No. 6, District 1, Fangxingyuan, Fangzhuang, Fengtai District, Beijing, P.R. China
100078
Beijing
China |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Aged 18 years or older
2. Patients suffering postoperative gastroparesis of digestive cancer
3. Local identification is cold pattern. This means that, this kind of patients prefer warm to cold, likes hot food and hates cold one)
Exclusion criteria:
1. Gastroscope or gastrointestinal contrast detection indicates that the patient is suffering mechanical intestinal obstruction
2. Patients with other diseases such as diabetes or scleroderma ,which may cause gastroparesis
3. Patients taking drugs like morphine and atropine which affect the function of gastic smooth muscle
4. Patients having rash, papules, erythema, herpes, exfoliative dermatitis or ulcerative dermatitis in the abdominal skin
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Postoperative gastroparesis of digestive cancer
Cancer
Ill-defined sites within the digestive system
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Intervention(s)
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This is a double-blind randomised parallel group multi-site trial.120 volunteers are divided into two groups by a certain people who won?t participate in the clinical observation so as to ensure the double-blind observation.
Patients in Group 1 will be treated with ?Wei Tan Wai Fu Fang? as well as conventional therapy (parenteral nutrition, gastrointestinal decompression, prokinetic drugs).
Patients in Group 2. will be treated with the placebo of ?Wei Tan Wai Fu Fang? and conventional therapy.
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Primary Outcome(s)
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Clinical efficiency: It is effective when a patient restores motility in two weeks or he is able to take in nutrients by himself after unplugging the nasogastric tube. It is measured by the Gastroparesis Cardinal Symptom Index.
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Secondary Outcome(s)
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1. Gastroparesis symptom score
2. The amount of stomach drainage or vomiting
Outcomes will be recorded on the 1st, 3rd, 5th, 7th and 14th day of the treatment.
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Secondary ID(s)
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D131100002213003
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Source(s) of Monetary Support
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Beijing Municipal Science and Technology Commission (China)
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Ethics review
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Status:
Approval date:
Contact:
Clinical Research Ethics Committee Office of Dongfang Hospital Affiliated to Beijing University of Chinese Medicine
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/12/2014 |
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URL:
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