Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-24 @ 3:05 PM
NCT ID:
NCT01154959
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years and above
* Residing in or around Chennai or Madurai
* No anti-TB treatment in the past or should have had less than one month of treatment (but less than one week in the preceding one month before enrollment in the study)
* At least two sputum smears should be positive for tubercle bacilli by fluorescent microscopy
* Express willingness to attend the treatment centre for supervised treatment
* Express willingness for home visits by the staff of the centre
* Express willingness to give written informed consent
Exclusion Criteria:
* Body weight less than 30 kg
* Hepatic or renal disease as evidenced by clinical or biochemical abnormalities
* Diabetes mellitus
* A history of seizure or loss of consciousness
* Psychiatric illness
* An abnormal electrocardiogram or anti-arrhythmic medication
* Those in a moribund state
* Sero-positive for HIV antibodies
* Pregnancy or lactation
* Visual disorders other than refractory error
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01154959
Study Brief:
Protocol Section:
NCT01154959