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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01592149
Other study ID # 16235
Secondary ID
Status Completed
Phase N/A
First received April 13, 2012
Last updated February 10, 2015
Start date May 2012
Est. completion date January 2015

Study information

Verified date February 2015
Source Bayer
Contact n/a
Is FDA regulated No
Health authority India: Drugs Controller General of India
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 16629
Est. completion date January 2015
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Intervention

Other:
No Drug
No intervention will be given to subjects, survey of loss of appetite in patients suffering from various healthcare disorders.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of patients with loss of appetite 1 Day No
Secondary Percentage of patients with fatigue 1 Day No
Secondary Distribution of fatigue among the patients with respect to disease 1 Day No
Secondary Percentage of patients with moderate to very severe Fatigue. 1 Day No
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