Channa Striata and Curcuma Domestica Supplementation in Patients With Active Pulmonary Tuberculosis

NCT07887724 | Recruiting DMC

• 1 other identifier: USU Tuberculosis Nutrition
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to evaluate the effect of combined supplementation with Channa striata extract and Curcuma domestica rhizome on nutritional status, inflammatory markers, and quality of life in patients with active pulmonary tuberculosis receiving standard anti tuberculosis treatment at public health centers in Medan City. Pulmonary tuberculosis is frequently accompanied by malnutrition, persistent systemic inflammation, and impaired quality of life, all of which can delay recovery and worsen clinical outcomes. Channa striata is a rich source of high quality protein and albumin that may support nutritional recovery, while Curcuma domestica contains curcumin with well documented anti inflammatory properties. This study will assess whether the combined supplementation provides additional benefits in improving nutritional status, reducing inflammatory markers, and enhancing health related quality of life compared with standard treatment alone. The findings are expected to provide evidence for a safe, affordable, and locally available nutritional intervention that may complement conventional tuberculosis management.

Conditions

Pulmonary Tuberculosis

Keywords

Channa striata; Curcuma domestica; Nutritional Status; Inflammatory Markers; Quality of Life

Outcome Measures

Primary Outcomes (4)

• Interleukin-6 Concentration

  Interleukin-6 (IL-6) concentration will be measured in \[serum/plasma\] using \[laboratory assay\] and reported in \[unit\].

  baseline and 4 weeks

• C-Reactive Protein Concentration

  C-reactive protein (CRP) concentration will be measured in \[serum/plasma\] using \[laboratory method\] and reported in \[unit\].

  baseline and 4 weeks

• Health-Related Quality of Life Measured Using the EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L) Index

  Health-related quality of life will be assessed using the EuroQol Five-Dimension Five-Level questionnaire (EQ-5D-5L). Responses will be converted into an index value using the Indonesian value set. Index values range from -0.865 to 1.000, with higher values indicating better health-related quality of life.

  baseline and 4 weeks

• Body Weight

  Body weight will be measured using a digital weighing scale and reported in kilograms (kg).

  Baseline and week 4

Secondary Outcomes (3)

• Body Mass Index

  Baseline and week 4

• Muscle Mass

  Baseline and week 4

• Mid-Upper Arm Circumference

  Baseline and week 4

Study Arms (2)

Experimental : Channa Striata and Curcuma

EXPERIMENTAL

Channa striata 5gr and curcuma domestica rhizoma 250mg

Dietary Supplement: CHANA STRIATA AND CURCUMA

Placebo

PLACEBO COMPARATOR

maltodekstrin

Dietary Supplement: Maltodextrin (Placebo)

Interventions

CHANA STRIATA AND CURCUMA DIETARY_SUPPLEMENT

Channa striata 5gr and curcuma 250mg

Experimental : Channa Striata and Curcuma

Maltodextrin (Placebo) DIETARY_SUPPLEMENT

Maltodextrin

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged ≥18 years.
• Body Mass Index (BMI) \<22.9 kg/m².
• Newly diagnosed pulmonary tuberculosis (TB).
• Diagnosis confirmed by bacteriological and/or clinical-radiological findings.
• Have not received anti-tuberculosis treatment, or have received treatment for less than two weeks.
• Willing to participate in the study by providing written informed consent and signing the Informed Consent Form.

You may not qualify if:

• Pregnant or breastfeeding women.
• Individuals who are overweight or obese.
• Individuals with comorbidities such as diabetes mellitus, HIV, impaired kidney function, or impaired liver function.
• Patients with drug-resistant tuberculosis, including MDR-TB or XDR-TB, or patients who previously failed an anti-tuberculosis treatment regimen.
• Patients with extrapulmonary tuberculosis.
• Patients who have consumed snakehead fish supplements, curcuma supplements, or high-dose multivitamin supplements within the previous two weeks.
• Patients with a history of allergy to fish or turmeric-derived products. Patients with swallowing disorders or gastrointestinal diseases that may affect supplement absorption.
• Patients who are uncooperative or discontinue treatment before completing the study.

Sponsors & Collaborators

• DINA KEUMALA SARI: lead

Study Sites (2)

Nutrition Department, Universitas sumatera utara, Medan, Indonesia

Medan, North Sumatera, 20132, Indonesia

RECRUITING

Nutrition Department, Universitas sumatera utara, Medan, Indonesia

Medan, North Sumatera, Indonesia

RECRUITING

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Interventions

turmeric extract; maltodextrin

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Aprillia Kusuma Putri

CONTACT

+628116590096; aprilliakusuma0104@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: prof

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: October 21, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: October 21, 2026

Record last verified: 2026-10

Locations

ID (2)