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Constipation is the most common complaint in childhood gastrointestinal disease,affecting an estimated 20% of the global children.The treatment strategies consist of diet control,behavioural intervention and oral and sometimes rectal laxatives. Given higher success rate and fewer side effects,the laxative PEG3350 has been considered the first choice in childhood constipation.However, effectiveness of PEG 3350 laxative is not lasting, additional treatment interventions are still necessary.With an unsatisfactory response to current treatments, many patients seek help from Chinese Herbal Medicine.In view of the traditional theory, childhood constipation is derived from weakness of gastric and splenic function.The functional weakness is characterized by food stagnation and further pathological heat accumulation in the gastrointestine. The food stagnation can slow the gastrointestinal motility while heat causes constipation by drying the intestines and their content. Therefore, the therapeutic principles and practices for childhood constipation must focus on the pathophysiological basis accordingly. In the documented traditional medicine dictionary(Pi Wei Lun), Xiaojidaozhi Decoction is well described in improving the gastric and splenic function, eliminating food stagnation and removing pathological heat accumulation, and it has always been used in treatment of constipation throughout Asia since the first description in Pi Wei Lun in 1249. It comprises twelve herbs. Through the combined action of these herbs, Xiaojidaozhi Decoction can increase fluid in the intestines and facilitate the gastrointestinal motility, relieving the symptoms of constipation. Despite of the long history of successful use of Xiaojidaozhi Decoction in childhood constipation, a large randomized placebo-controlled trial is still not available.The aim of this study was to explore the clinical efficacy and safety of Chinese herbal medicine Xiaojidaozhi Decoction in the treatment of childhood constipation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Xiaojidaozhi Decoction | Active Comparator | Xiaojidaozhi Decoction and Fiberform and Toilet training are used for treatment of childhood Constipation |
|
| non-Xiaojidaozhi Decoction | Placebo Comparator | Placebo and Fiberform and Toilet training are used for treatment of childhood Constipation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xiaojidaozhi Decoction | Drug | Mixture of twelve Chinese herbal medicines granule |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of overall efficacy | Efficacy is ranked as cured, improved, same/worse | week 8(end of treatment) |
| Percentage of overall efficacy | Efficacy is ranked as cured, improved, same/worse | week 20(end of follow-up) |
| Baseline of constipation score in the beginning of treatment | Constipation is evaluated and scored on the related symptoms of stool frequency, appearance,consistency and incontinence | beginning of treatment(baseline) |
| Change of constipation score from the baseline in the end of treatment | Constipation is evaluated and scored on the related symptoms of stool frequency, appearance,consistency and incontinence | week 8(end of treatment) |
| Change of constipation score from the baseline in the end of follow-up | Constipation is evaluated and scored on the related symptoms of stool frequency, appearance,consistency and incontinence | week 20(end of follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | The adverse events reported in treatment | Within week 20(end of follow-up) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shengjing Hospital | Shenyang | Liaoning | 110004 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15479678 | Background | Voskuijl W, de Lorijn F, Verwijs W, Hogeman P, Heijmans J, Makel W, Taminiau J, Benninga M. PEG 3350 (Transipeg) versus lactulose in the treatment of childhood functional constipation: a double blind, randomised, controlled, multicentre trial. Gut. 2004 Nov;53(11):1590-4. doi: 10.1136/gut.2004.043620. | |
| 16000928 | Background |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Placebo | Drug | Mixture of 10% Chinese herbal medicines granule and 90% artificial gum |
|
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| Fiberform | Drug | Fiberform is a low-phytate wheat fibre which can increase the gastrointestinal motility. |
|
| Toilet training | Behavioral | Toilet training has been considered a routine method in treatment of constipation |
|
| Tran LC, Di Palma JA. Lack of lasting effectiveness of PEG 3350 laxative treatment of constipation. J Clin Gastroenterol. 2005 Aug;39(7):600-2. doi: 10.1097/01.mcg.0000170769.67320.47. |
| 21045817 | Background | Cheng CW, Bian ZX, Zhu LX, Wu JC, Sung JJ. Efficacy of a Chinese herbal proprietary medicine (Hemp Seed Pill) for functional constipation. Am J Gastroenterol. 2011 Jan;106(1):120-9. doi: 10.1038/ajg.2010.305. Epub 2010 Nov 2. |
| 33938874 | Derived | Qiao L, Wang LJ, Wang Y, Chen Y, Zhang HL, Zhang SC. A Randomized, Double-Blind, and Placebo-Controlled Trial of Chinese Herbal Medicine in the Treatment of Childhood Constipation. Clin Transl Gastroenterol. 2021 May 3;12(5):e00345. doi: 10.14309/ctg.0000000000000345. |