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Compare the effectiveness of two types of drugs to treat tuberculosis

Survey of treatment outcome smear-positive pulmonary tuberculosis patients Treated with fixed-dose drug combination regime in compared whith those separate regime: a randomized clinical trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014051917764N1
Enrollment
300
Registered
2014-09-13
Start date
2014-06-22
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis. Tuberculosis of lung, confirmed by sputum microscopy with or without culture

Interventions

Intervention 1: 2. The intervention group will be treated with a combination of Anti-TB drug and whit a fixed dose that contains Rifampicin 8-12 mg per kg body weight, Isoniazid 4-6 mg per kg body wei
Treatment - Drugs
2. The intervention group will be treated with a combination of Anti-TB drug and whit a fixed dose that contains Rifampicin 8-12 mg per kg body weight, Isoniazid 4-6 mg per kg body weight, Pyrazinamid
3.The control group will be treated with the separate Anti-TB drug regimen that contains Rifampicin 8-12 mg per kg body weight, Isoniazid 4-6 mg per kg body weight, Pyrazinamide 20-30 mg per kg body w

Sponsors

vice chancellor for research, Urmia University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
13 Years to No maximum

Inclusion criteria

Inclusion criteria: Inclusion Criteria: New cases of sputum smear positive; Patient weight more than 30kg; Adult (greater than13 years); No disease - diabetes, immune deficiency, liver or kidney disease; Informed consent. Exclusion Criteria: Smear-negative tuberculosis patients; Patients with a history of anti-TB medication use; Children younger than 13 years; Patients weighing less than 30 kg; Tuberculosis patients with diabetes, immune deficiency, liver or kidney disease; Lack of consent to participate in the study.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Sputum conversion rate. Timepoint: 2 , 3 and 6 month after Starting Treatment. Method of measurement: sputum smear status is investigated by optical microscope at the end of the second, third and sixth months of treatment and the result are registered in the checklist.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFallah Saeid

Urmia University of Medical Sciences

s.fallah@goums.ac.ir+98 17 3327 6425

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026