Ignite Creation Date:
2024-05-06 @ 10:37 AM
Last Modification Date:
2024-10-26 @ 12:32 PM
Study NCT ID:
NCT03300804
Status:
COMPLETED
Last Update Posted:
2022-03-14
First Post:
2010-03-28
Brief Title:
Dose Escalation Trial of Traditional Chinese Medicine for Irritable Bowel Syndrome TCM- IBS
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Dose Escalation Trial Of Traditional Chinese Medicine For Irritable Bowel Syndrome
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TCM-IBS
Brief Summary:
The purpose of this study is to determine whether a 20- herb formulation as a well characterised extract is efficacious in treating irritable bowel syndrome IBS and also to identify efficacious and safe dosage of the formulation in treating IBS
Detailed Description:
The Specific aims of the project are
1 To determine whether a 20- herb formulation improves pain discomfort and disturbed bowel frequency in patients with Irritable Bowel Syndrome who have been disappointed with current conventional Western medicine
2 To identify an optimal dosage of the 20- herb formulation that is safe and well tolerated for up to 8 weeks of treatment among 2 dosages This is determined by relief of symptoms of IBS in a dose escalation placebo-controlled double- blind randomized clinical trial in conjunction with indices of safety and tolerability
1 To determine whether a 20- herb formulation improves pain discomfort and disturbed bowel frequency in patients with Irritable Bowel Syndrome who have been disappointed with current conventional Western medicine
2 To identify an optimal dosage of the 20- herb formulation that is safe and well tolerated for up to 8 weeks of treatment among 2 dosages This is determined by relief of symptoms of IBS in a dose escalation placebo-controlled double- blind randomized clinical trial in conjunction with indices of safety and tolerability
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1U19AT003266-01 | NIH | None | httpsreporternihgovquickSearch1U19AT003266-01 |