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A study comparing 3 percent and 7 percent hypertonic saline solutions for sputum induction in adults having presumptive pulmonary tuberculosis

A randomized controlled trial comparing 3 percent versus 7 percent hypertonic saline for sputum induction in adults with presumptive pulmonary tuberculosis, in terms of sputum adequacy and safety at a tertiary care hospital. - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/10/096131
Enrollment
120
Registered
2025-10-16
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: J22- Unspecified acute lower respiratory infection

Interventions

Intervention1: 7% HYPERTONIC SALINE: Intervention: • Name of intervention: 7% Hypertonic Saline • Type: Active intervention • Route of administration: Nebulization • Dosage/Form: 7% saline solutio
serves as comparator to assess efficacy and safety differences.

Sponsors

Dr Ruchi Dua
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adults aged eighteen years and above. Patients presenting with clinical or radiological features suggestive of pulmonary tuberculosis as per WHO criteria, such as cough for more than two weeks, fever, weight loss, night sweats, and chest radiograph showing infiltrates, cavitation, fibrotic changes, miliary pattern, or mediastinal lymphadenopathy. Patients unable to produce sputum spontaneously. Patients willing to participate and providing written informed consent to undergo sputum induction.

Exclusion criteria

Exclusion criteria: Oxygen saturation less than ninety-two percent on room air. Known or uncontrolled asthma or chronic obstructive pulmonary disease. Active hemoptysis at the time of enrolment.

Design outcomes

Primary

MeasureTime frame
Adequacy and Volume of Sputum Sample based on NTEP criteria more than 2 ml with adequate cellular content as per Bartlett scoreTimepoint: At baseline

Secondary

MeasureTime frame
TB Detection Rate by GeneXpert or NAAT & AFB smear positivity Timepoint: At baseline;Incidence of Side Effects like dyspnea-VAS, excessive coughing-1-10 scale, throat irritation, desaturation more than 3 percent upto 30 minutes post nebulisation Timepoint: within 30 min post procedure;Patient Comfort Assessment using Visual Analogue Scale using VAS on 1–10 scale Timepoint: baseline during procedure

Countries

India

Contacts

Public ContactRUCHI DUA

AIIMS RISHIKESH

RUCHI.PULM@AIIMSRISHIKESH.EDU.IN7895973469

Outcome results

None listed

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