Diarrhea Clinical Trial
Official title:
Introduction of New Hypo-Osmolar ORS (Recommended by WHO) for Routine Use in the Management of Diarrhoeal Diseases – A Phase IV Surveillance Study
Verified date | February 2007 |
Source | Society for Applied Studies |
Contact | n/a |
Is FDA regulated | No |
Health authority | India: Ministry of Health |
Study type | Interventional |
For more than 25 years WHO and UNICEF have recommended a single formulation of glucose-based
Oral Rehydration Salts (ORS) to prevent or treat dehydration from diarrhoea irrespective of
the cause or age group affected. This product has proven effective and contributed
substantially to the dramatic global reduction in mortality from diarrhoeal disease during
the period.
Based on more than two decades of research and recommendations by an expert group, WHO and
UNICEF reviewed the effectiveness of a new ORS formula with reduced concentration of glucose
and salts. Because of the improved effectiveness of this new ORS solution WHO and UNICEF
recommended that countries use and manufacture this new formulation in place of the old one.
While recommending this new ORS the experts also recommended that further monitoring is
desirable to better assess the risk, if any of symptomatic hyponatraemia (low blood level of
sodium salt). This is a surveillance study to evaluate adverse effect of routinely using the
new ORS in a hospital admitting over 20,000 patients with diarrhea of all ages including
cholera. If the new ORS is found safe, it will provide added confidence in its global use.
Status | Completed |
Enrollment | 27966 |
Est. completion date | April 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - All patients admitted with diarrhoea over the study period of 12 months will be eligible for the study, which include men, women and children. |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
India | ID & BG Hospital, Beliaghata, Kolkata-700 010 | Kolkata | West Bengal |
Lead Sponsor | Collaborator |
---|---|
Society for Applied Studies |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Symptomatic hyponatraemia with clinical features like convulsion or drowsiness or coma. | |||
Secondary | Unanticipated adverse effect associated with the routine use of hypo-osmolar ORS solution on a large scale |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT06283784 -
Study To Evaluate The Efficacy of a Proprietary Mix of Live Probiotics In The Prophylaxis Of Diarrhea In Adult Patients
|
N/A | |
Recruiting |
NCT03851835 -
Multi-DOSE Oral Ondansetron for Pediatric Acute GastroEnteritis
|
Phase 3 | |
Completed |
NCT04003181 -
The Pathogenesis of Chronic Diarrhoea After Treatment for Cancer in Cecum and the Ascending Colon
|
N/A | |
Completed |
NCT03596827 -
The Protective Immune Response to Attenuated Enterotoxigenic Escherichia Coli Infection
|
N/A | |
Recruiting |
NCT05372068 -
Cement flooRs AnD chiLd hEalth (CRADLE)
|
N/A | |
Completed |
NCT03972618 -
Evaluation of the Efficacy of Sawyer Point One Filters in Schools and Homes in the Dominican Republic
|
N/A | |
Completed |
NCT05207618 -
Utility of the Administration of Chesnut and Quebracho Extract for Irritable Bowel Syndrome Diarrhea Predominant
|
N/A | |
Not yet recruiting |
NCT05052489 -
Registry and Clinical Observation of Children With Diarrhoeal Disease
|
||
Completed |
NCT02428647 -
Lao Zinc Study: Effects of Two Forms of Daily Preventive Zinc Versus Therapeutic Zinc Supplementation
|
N/A | |
Completed |
NCT02541695 -
Characterization of Resistance Against Live-attenuated Diarrhoeagenic E. Coli
|
N/A | |
Completed |
NCT02197780 -
Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD
|
N/A | |
Completed |
NCT01968408 -
Lactobacillus Reuteri DSM 17938 in Preventing Nosocomial Diarrhea in Children
|
Phase 3 | |
Completed |
NCT01739231 -
Live Attenuated ETEC Vaccine ACE527 With and Without dmLT Adjuvant in Adults
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT01382199 -
Recombinant Human Lactoferrin Administered Orally for the Prevention of Antibiotic Associated Diarrhea in Adult Patients
|
Phase 3 | |
Completed |
NCT01371656 -
Levofloxacin in Preventing Infection in Young Patients With Acute Leukemia Receiving Chemotherapy or Undergoing Stem Cell Transplantation
|
Phase 3 | |
Terminated |
NCT01048567 -
Efficacy and Safety of Lactobacillus Acidophilus/Rhamnosus Combination for the Prevention of Antibiotic-associated Diarrhea in the Elderly
|
Phase 2 | |
Terminated |
NCT01472211 -
Water-based Zinc Intervention Trial in Zinc Deficient Children
|
Phase 0 | |
Completed |
NCT01438645 -
ScopeGuide-assisted Colonoscopy Versus Conventional Colonoscopy
|
N/A | |
Completed |
NCT00914225 -
Effect of Bednets and a Water Purification Device on HIV Disease Progression Among ART naïve Patients in Kenya
|
N/A | |
Completed |
NCT00760851 -
Yogurt Study in Children 2-4 Years Old Attending Daycare
|
Phase 3 |