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New Hypo-Osmolar ORS (Recommended by WHO) for Routine Use in the Diarrhea Management– Surveillance Study for Adverse Effects
This study has been completed.
First Received: June 22, 2007   No Changes Posted
Sponsored by: Society for Applied Studies
Information provided by: Society for Applied Studies
ClinicalTrials.gov Identifier: NCT00490932
  Purpose

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.


Condition Intervention Phase
Diarrhea
Dysentery
Drug: Hypo-osmolar ORS
Phase IV

MedlinePlus related topics: Diarrhea
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety Study
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

Further study details as provided by Society for Applied Studies:

Primary Outcome Measures:
  • Symptomatic hyponatraemia with clinical features like convulsion or drowsiness or coma.

Secondary Outcome Measures:
  • Unanticipated adverse effect associated with the routine use of hypo-osmolar ORS solution on a large scale

Enrollment: 27966
Study Start Date: March 2005
Study Completion Date: April 2007
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00490932

Locations
India, West Bengal
ID & BG Hospital, Beliaghata, Kolkata-700 010
Kolkata, West Bengal, India, 700010
Sponsors and Collaborators
Society for Applied Studies
Investigators
Principal Investigator: Dr. Dilip Mahalanabis, MBBS Reviewed and approved by the Ethics Review Committee of the Society for Applied Studies (FWA 00001757)
  More Information

No publications provided

Study ID Numbers: ID04001
Study First Received: June 22, 2007
Last Updated: June 22, 2007
ClinicalTrials.gov Identifier: NCT00490932     History of Changes
Health Authority: India: Ministry of Health

Keywords provided by Society for Applied Studies:
Watery diarrhea
Bloody diarrhea

Study placed in the following topic categories:
Signs and Symptoms
Digestive System Diseases
Diarrhea
Signs and Symptoms, Digestive
Gastrointestinal Diseases
Dysentery
Intestinal Diseases
Gastroenteritis

Additional relevant MeSH terms:
Signs and Symptoms
Digestive System Diseases
Diarrhea
Signs and Symptoms, Digestive
Gastrointestinal Diseases
Dysentery
Intestinal Diseases
Gastroenteritis

ClinicalTrials.gov processed this record on May 07, 2009