|
Main
|
|
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. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2015 |
|
Main ID: |
NCT00319358 |
|
Date of registration:
|
26/04/2006 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Role of Antioxidants Supplementation in Chronic Pancreatitis
|
|
Scientific title:
|
Effect of Antioxidant Supplementation on Pain, Antioxidant Profile and Oxidative Stress in Patients With Chronic Pancreatitis |
|
Date of first enrolment:
|
October 2003 |
|
Target sample size:
|
127 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00319358 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
|
|
Phase:
|
Phase 3
|
|
|
Countries of recruitment
|
|
India
| | | | | | | |
|
Contacts
|
|
Name:
|
Payal Bhardwaj, MSc |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
dept. of Gastroenterology, A.I.I.M.S. , New Delhi |
|
|
Name:
|
Pramod K Garg, MD, DM |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Dept. of Gastroenterology, All India Institute of Medical Sciences, New Delhi |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- CP with significant pain i.e., at least one episode of pain in a month requiring oral
analgesic or one episode of severe pain in last three months requiring
hospitalization
Exclusion Criteria:
- Painless disease
- Current pain more likely due to non-pancreatic origin
- If the patient already has an intervention in the form decompressive therapy i.e.,
surgery or endoscopic sphincterotomy/ stenting or ESWL
- Systemic conditions like CRF, malignancy, hypertension, and pregnancy
- Complications like pseudocyst, pancreatic abscess
- Patients who would have received antioxidants in the preceding 4 weeks
- Narcotic addicts
- Uncontrolled diabetes
- Comorbid conditions like liver diseases
Age minimum:
12 Years
Age maximum:
70 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Chronic Pancreatitis
|
|
Intervention(s)
|
|
Dietary Supplement: Placebo
|
|
Dietary Supplement: Antioxidants
|
|
Primary Outcome(s)
|
|
Reduction in the number of painful days per month due to chronic pancreatitis
[Time Frame: 6 months]
|
|
Secondary Outcome(s)
|
|
Percentage of patients who are pain-free
[Time Frame: 6 months]
|
|
Decrease in no. of severe attacks requiring hospitalization
[Time Frame: 6 months]
|
|
Increase in markers of antioxidant defense in the intervention group compared to placebo group and decrease in oxidative stress parameters in patients after intervention compared to placebo
[Time Frame: 6 months]
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|