- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01592149
Survey of Prevalence of Loss of Appetite in Subject With Health Disorders (SPLASH)
February 10, 2015 updated by: Bayer
Survey of Prevalence of Loss of Appetite in Subject With Health Disorders.
The study is an epidemiological survey to find out the incidence of loss of appetite in Indian patients suffering from various health disorders.
This survey will be conducted to obtain information on appetite from a total of 17500 subjects This study does not intend to study the effect of any drugs.
The primary source of information will be the subjects themselves.
The study will be conducted at 275 - 350 centres spread across India.This is a single visit study.The physician will conduct routine clinical, physical and general examination.
Study Overview
Study Type
Observational
Enrollment (Actual)
16629
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Many Locations, India
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patient with various health related disoder
Description
Inclusion Criteria:
- Men and Non-pregnant women ≥ 18 years of age recuperating from healthcare disorders like:Malaria fever, Typhoid or enteric fever
- Hepatitis
- Acute infections including respiratory, urinary tract infections etc treated with antibiotic
- Tuberculosis
- Patient discharged from hospital after general surgical procedures like acute appendectomy, etc.
- Any other condition
Exclusion Criteria:
- Patients unwilling to provide informed consent & comply with the study procedure
- Patient using drugs which affect appetite like Cyproheptadine etc.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Group 1
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No intervention will be given to subjects, survey of loss of appetite in patients suffering from various healthcare disorders.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Percentage of patients with loss of appetite
Time Frame: 1 Day
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1 Day
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Percentage of patients with fatigue
Time Frame: 1 Day
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1 Day
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Distribution of fatigue among the patients with respect to disease
Time Frame: 1 Day
|
1 Day
|
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Percentage of patients with moderate to very severe Fatigue.
Time Frame: 1 Day
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1 Day
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (Actual)
March 1, 2014
Study Completion (Actual)
January 1, 2015
Study Registration Dates
First Submitted
April 13, 2012
First Submitted That Met QC Criteria
May 3, 2012
First Posted (Estimate)
May 7, 2012
Study Record Updates
Last Update Posted (Estimate)
February 11, 2015
Last Update Submitted That Met QC Criteria
February 10, 2015
Last Verified
February 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16235
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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