Constipation Clinical Trial
Official title:
Efficacy of Chinese Herbal Medicine Xiaojidaozhi Decoction in the Treatment of Childhood Functional Constipation: a Double Blind, Randomized and Placebo-controlled Trial
Verified date | November 2023 |
Source | Shengjing Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | May 1, 2018 |
Est. primary completion date | May 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Years to 14 Years |
Eligibility | Inclusion Criteria: 1. Clinical diagnosis of childhood constipation 2. Criteria of constipation meets the Rome IV criteria(H3a) 3. Must be able to swallow capsules Exclusion Criteria: 1. Digestive tract diseases 2. Neurologic diseases 3. Endocrine diseases 4. Metabolic diseases 5. Gastrointestinal surgery 6. Using drugs which can take impact on bowl motility |
Country | Name | City | State |
---|---|---|---|
China | Shengjing Hospital | Shenyang | Liaoning |
Lead Sponsor | Collaborator |
---|---|
Shengjing Hospital |
China,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percentage of overall efficacy | Efficacy is ranked as cured, improved, same/worse | week 8(end of treatment) | |
Primary | Percentage of overall efficacy | Efficacy is ranked as cured, improved, same/worse | week 20(end of follow-up) | |
Primary | 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) | |
Primary | 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) | |
Primary | 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) | |
Secondary | Incidence of Treatment-Emergent Adverse Events | The adverse events reported in treatment | Within week 20(end of follow-up) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05517460 -
The Efficacy of Auricular Acupressure on Improving Constipation Among Residents in Community Rehabilitation Center
|
N/A | |
Recruiting |
NCT06292949 -
Clinical Study of Resistant Starch in Improving Constipation
|
N/A | |
Recruiting |
NCT04132661 -
MRI Assessment of Mode of Action of Bisacodyl, Single Dose
|
Phase 4 | |
Completed |
NCT02726295 -
The Efficacy of Mutaflor(E. Coli Nissle 1917, Mutaflor®) for Chronic Constipation:Multicenter Study
|
Phase 4 | |
Terminated |
NCT02839889 -
Tolerability, Safety, and Feasibility of Naloxegol in Patients With Cancer and OIC (Opioid Induced Constipation)
|
Phase 4 | |
Recruiting |
NCT02255747 -
Anal Dilatation for Infants and Children With Constipation
|
N/A | |
Completed |
NCT02246647 -
Biomarkers for Intestinal Permeability in Patients With Constipation
|
||
Completed |
NCT01566409 -
Maintenance Treatment for Children With Constipation
|
N/A | |
Completed |
NCT02658201 -
Ultrafast MRI Imaging to Exclude Constipation
|
N/A | |
Completed |
NCT01710579 -
Normal Values in Ano-rectal 3D High Resolution Manometry
|
N/A | |
Completed |
NCT01695915 -
Diurnal Variation in Rectal Diameter
|
N/A | |
Completed |
NCT02863848 -
Effect of Inulin-type Fructans on Constipated Children.
|
N/A | |
Completed |
NCT01438567 -
A Study to Demonstrate Improvement in Symptoms of Constipation in Subjects That Require Around-the-clock Opioid Pain Killer Therapy
|
Phase 3 | |
Completed |
NCT01474499 -
A Trial of Docusate Sodium and Sorbitol Rectal Solution for the in Patients With Constipation
|
Phase 3 | |
Completed |
NCT01411501 -
Efficacy and Safety of Acupuncture for Functional Constipation
|
Phase 3 | |
Completed |
NCT00931853 -
Efficacy and Tolerability of Cassia Fistula Plus Senna Alexandrina Miller (Sugar Free) in the Chronic Functional Constipation (CFC).
|
Phase 3 | |
Completed |
NCT01170039 -
The Effectiveness of Lubiprostone in Constipated Diabetics
|
Phase 4 | |
Active, not recruiting |
NCT02442115 -
Impact of Improving GI Symptoms on Autism Symptoms and Oxidative Stress
|
||
Completed |
NCT00994851 -
Evaluation of Cassia Fistula + Senna Alexandrina Miller in the Chronic Functional Constipation Treatment.
|
Phase 3 | |
Terminated |
NCT01003249 -
Dysfunctional Voiding and Lower Urinary Tract Symptoms With Baclofen
|
Phase 4 |