Evaluating the Impact of Ayurvedic Treatment as an Adjunct to Antituberculosis Therapy on BMI in Tuberculosis Patients.

Efficacy Safety and Tolerability of Ayurveda regimen as an adjunct to antituberculosis treatment ATT and macronutrient supplementation on body weight nutritional outcomes and quality of life in adults with newly diagnosed drug sensitive smear positive Pulmonary Tuberculosis An open label randomized controlled parallel arm clinical study - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/06/089191

Enrollment

1250

Registered

2025-06-19

Start date

Unknown

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

Health Condition 1: A150- Tuberculosis of lung

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.Willing and able to give informed consent for participation in the trial. 2.Individuals of any gender aged 18 years or above. 3.Newly diagnosed cases of Pulmonary Tuberculosis (M. Tb positive on molecular test e.g. GeneXpert or TRUENAT or sputum smear positive pulmonary TB on direct microscopy for acid fast bacilli (at least 1+ on the IUATLD/WHO scale) 4.Sensitive to rifampicin by sputum based drug sensitivity test (may be sensitive or resistant to isoniazid) 5.Female participants of child bearing potential and male participants whose partner is of child bearing potential must be willing to ensure that they or their partner use effective contraception during the trial and for 3 months thereafter. 6.Liver function tests within reference range (as per the reference value of the laboratory assigned for the study investigations)

Exclusion criteria

Exclusion criteria: 1.Patients with prehistory of TB, EP, relapse, and other forms of TB 2.Participants with pre-existing HIV, liver, Kidney and cardiac diseases 3.Hb 10% 4.Pregnancy and lactation, Hypersensitivity to ATT

Design outcomes

Primary

Measure	Time frame
â?¢Change in body mass index (BMI) from baseline to day 180Timepoint: Time points- Baseline, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180	—

Secondary

Measure	Time frame
â?¢Change in body weight from baseline to day 180Timepoint: Time points- Day 1, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180;â?¢ Change in body composition from baseline to day 180, assessed through Dual Energy X-ray Absorptiometry (DEXA)Timepoint: Time points- Baseline, Day 180;â?¢ Change in health-related quality-of-life (HRQoL) in pulmonary tuberculosis from baseline to day 180, assessed through SF-12 questionnaireTimepoint: Time points- Baseline, Day 90, Day 180;â?¢Time to attain sputum smear negative for AFBTimepoint: Time points- Baseline, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180;â?¢Proportion of participants who attain sputum smear negative for AFB at each follow-up time points (Timepoint: Baseline, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180) and culture conversion to negative status through MGIT (Mycobacteria Growth Indicator Tube)(Time points - Baseline, Day 180);â?¢ Quantitative assessment of mycobacterial load through quantitative polymerase chain reaction (qPCR for Mycobacterium tuberculosis)Timepoint: Baseline, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180;â?¢Incidence of treatment emergent adverse eventsTimepoint: Baseline to Day 180;â?¢Change in laboratory parameters of safety (CBC, LFT, KFT)Timepoint: Baseline, Day 30, Day 90, Day 180;â?¢ To assess the tolerability of Ayurvedic therapeutic regimen as adjunct to ATT and macronutrient supplementation in Pulmonary tuberculosis (through assessment of treatment adherence, proportion of participants dropped out or withdrawn from the study due to AE/ADR and participant self reported tolerability)Timepoint: Day 1, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180	—

Measure

Time frame

â?¢Change in body weight from baseline to day 180Timepoint: Time points- Day 1, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180;â?¢ Change in body composition from baseline to day 180, assessed through Dual Energy X-ray Absorptiometry (DEXA)Timepoint: Time points- Baseline, Day 180;â?¢ Change in health-related quality-of-life (HRQoL) in pulmonary tuberculosis from baseline to day 180, assessed through SF-12 questionnaireTimepoint: Time points- Baseline, Day 90, Day 180;â?¢Time to attain sputum smear negative for AFBTimepoint: Time points- Baseline, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180;â?¢Proportion of participants who attain sputum smear negative for AFB at each follow-up time points (Timepoint: Baseline, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180) and culture conversion to negative status through MGIT (Mycobacteria Growth Indicator Tube)(Time points - Baseline, Day 180);â?¢ Quantitative assessment of mycobacterial load through quantitative polymerase chain reaction (qPCR for Mycobacterium tuberculosis)Timepoint: Baseline, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180;â?¢Incidence of treatment emergent adverse eventsTimepoint: Baseline to Day 180;â?¢Change in laboratory parameters of safety (CBC, LFT, KFT)Timepoint: Baseline, Day 30, Day 90, Day 180;â?¢ To assess the tolerability of Ayurvedic therapeutic regimen as adjunct to ATT and macronutrient supplementation in Pulmonary tuberculosis (through assessment of treatment adherence, proportion of participants dropped out or withdrawn from the study due to AE/ADR and participant self reported tolerability)Timepoint: Day 1, Day 30, Day 60, Day 90, Day 120, Day 150, Day 180

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Countries

India

Contacts

Public ContactDr Sonali Sarkar

Jawaharlal Institute of Postgraduate Medical Education and Research Puducherry

sarkarsonaligh@gmail.com9442174663

Outcome results