Survey of Prevalence of Loss of Appetite in Subject With Health Disorders (SPLASH)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01592149
First received: April 13, 2012
Last updated: September 4, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Appetite
Other: No Drug

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Survey of Prevalence of Loss of Appetite in Subject With Health Disorders.

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Percentage of patients with loss of appetite [ Time Frame: 1 Day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients with fatigue [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
  • Distribution of fatigue among the patients with respect to disease [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
  • Percentage of patients with moderate to very severe Fatigue. [ Time Frame: 1 Day ] [ Designated as safety issue: No ]

Estimated Enrollment: 17500
Study Start Date: May 2012
Estimated Study Completion Date: February 2015
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Other: No Drug
No intervention will be given to subjects, survey of loss of appetite in patients suffering from various healthcare disorders.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patient with various health related disoder

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01592149

Locations
India
Many Locations, India
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01592149     History of Changes
Other Study ID Numbers: 16235
Study First Received: April 13, 2012
Last Updated: September 4, 2014
Health Authority: India: Drugs Controller General of India

Keywords provided by Bayer:
Appetite

Additional relevant MeSH terms:
Anorexia
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on September 11, 2014