Colonic Diseases, Functional Clinical Trial
Official title:
A Phase I, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study to Evaluate the Safety and Efficacy of a Combination Herbal Therapy (CHT), Versus Placebo in Improving the Overall Quality of Life and Symptoms in Patients With Irritable Bowel Syndrome (IBS)
This is an 8-week double-blind, placebo-controlled, randomized, parallel-group study with an additional two week baseline observation period to evaluate the safety of combination herbal therapy (CHT) versus placebo and short and long-term efficacy in terms of improved IBS, overall quality of life (QOL) and symptomatology.
Status | Completed |
Enrollment | 100 |
Est. completion date | January 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Men or women aged 18-70 - Diagnosis of irritable bowel syndrome based on the following criteria (ROME II): At least 12 weeks, which need not be consecutive, in the preceding 12 months of abdominal discomfort or pain (at least once per week) with at least 2 of the following features: - Relief with defecation; - Onset associated with a change in stool frequency; - Onset associated with a change in stool consistency. - At least two of the following on at least 25% of occasions or days in the last 3 months: - Fewer than three bowel movements a week; - More than three bowel movements a day; - Hard or lumpy stools; - Loose (mushy) or watery stools; - Straining during a bowel movement; - Urgency; - Feeling of incomplete bowel movement; - Passing mucus during a bowel movement; - Abdominal fullness, bloating or swelling. - Women of childbearing potential must be using an acceptable method of contraception. Exclusion Criteria: - History of severe or intractable IBS, defined as continuous, unremitting and severe abdominal pain greater than 12 hours/day - Concurrent diagnosis of any bowel disturbance that would interfere with the assessment or safety of the study - History of laxative abuse - Previous abdominal surgery (uncomplicated appendectomy, hysterectomy or cholecystectomy at least 6 months prior to entry acceptable) - History of metabolic or inflammatory disease that may affect bowel motility, eg., inflammatory bowel disease, diabetes mellitus, sarcoidosis - Use of the following concomitant medications: medications that can affect gastrointestinal (GI) motility; other investigational drug use (30 day "washout" required); medications affecting visceral perception; antidepressants; selective serotonin reuptake inhibitors; opioids; narcotic analgesics; antispasmodic and anticonvulsant agents; insulin or other hypoglycemic therapy; thyroid hormones; central nervous system (CNS) depressants. - Other significant illness as determined by Investigator - Pregnancy - History of drug or alcohol abuse within 2 years - Insufficient knowledge of English or Hebrew to complete self-assessments to participate in study - Any other reason for which Investigator feels that subject's compliance is at question or safety may be compromised. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Israel | Hadassah Medical Organization | Jerusalem |
Lead Sponsor | Collaborator |
---|---|
Hadassah Medical Organization |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate whether CHT administered orally (PO) induces a change in the overall QOL score from baseline values at 4 weeks of treatment measured via the IBS 36 questionnaire in patients with irritable bowel syndrome, relative to placebo | |||
Secondary | 30% change on the IBS-36 from baseline to 4 weeks ("no" or "yes") | |||
Secondary | Change on IBS-36 from 4 weeks (last treatment taken) and 8 weeks (i.e., after 4 weeks of "washout") | |||
Secondary | Change in IBS symptoms severity score from baseline to 4 weeks | |||
Secondary | Change in IBS symptoms severity score from 4 to 8 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05551052 -
CRC Detection Reliable Assessment With Blood
|
||
Completed |
NCT00153751 -
The Efficacy of Herbal Medicine in Relieving Symptoms and Change of Quality of Life of Patients With Irritable Bowel Syndrome (IBS)
|
Phase 2 | |
Completed |
NCT03922815 -
Adequacy of Anaesthesia for Colonoscopic Procedures
|
N/A | |
Not yet recruiting |
NCT06271538 -
Evaluation of Efficacy of Skål Pro Powder on Symptoms of Irritable Bowel Syndrome
|
Phase 4 | |
Completed |
NCT01176227 -
Efficacy of a Multi-strain Probiotic in the Treatment of Irritable Bowel Syndrome (IBS)
|
Phase 1/Phase 2 | |
Completed |
NCT01887834 -
Efficacy of a Multi-strain Probiotic in the Treatment of Irritable Bowel Syndrome
|
Phase 1/Phase 2 | |
Completed |
NCT01072903 -
The Role of Intestinal Inflammation in Irritable Bowel Syndrome (IBS)
|
N/A | |
Active, not recruiting |
NCT01028898 -
Abnormal Expression Proteins, Mitochondrial DNA and miRNA of Irritable Bowel Syndrome
|
N/A | |
Recruiting |
NCT03854422 -
For Easy, Fast and Comfortable Colonoscopy, Which Position
|
N/A | |
Completed |
NCT02551029 -
fMRI and Visceral Perception Upon Capsaicin Infusion
|
N/A | |
Completed |
NCT02716285 -
Peppermint Oil for the Treatment of Irritable Bowel Syndrome: Optimizing Therapeutic Strategies Using Targeted Delivery
|
Phase 3 | |
Completed |
NCT05340400 -
The Prevalence and Risk Factors of Irritable Bowel Syndrome Among Adults
|
||
Completed |
NCT00189033 -
Dietary Interventions in Irritable Bowel Syndrome: Soluble, Insoluble or no Fibre?
|
N/A |