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

NCT07887724 — Not applicable, Recruiting, 80 participants, DINA KEUMALA SARI

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The Effect of Combined Supplementation With Channa Striata and Curcuma Domestica Rhizome on Nutritional Status, Inflammatory Markers, and Quality of Life in Patients With Active Pulmonary TB at the Medan City Public Health Center

Registry	NCT07887724
Status	Recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, supportive care
Enrollment	80 (Estimated)
Sponsor	DINA KEUMALA SARI (Other)
Conditions	Pulmonary Tuberculosis
Interventions	CHANA STRIATA AND CURCUMA, Maltodextrin (Placebo) (Dietary supplement)
Dates	start 2026-08-01, primary completion 2026-11-30 (estimated), completion 2026-12-30 (estimated), first posted 2026-10-21, last updated 2026-10-21
Locations	2 sites in Indonesia

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Experimental : Channa Striata and Curcuma	Experimental	Dietary Supplement: CHANA STRIATA AND CURCUMA	Channa striata 5gr and curcuma domestica rhizoma 250mg
Placebo	Placebo comparator	Dietary Supplement: Maltodextrin (Placebo)	maltodekstrin

CHANA STRIATA AND CURCUMA (Dietary supplement): Channa striata 5gr and curcuma 250mg
Maltodextrin (Placebo) (Dietary supplement): Maltodextrin

+Outcome measures

Primary outcomes

Interleukin-6 Concentration [baseline and 4 weeks]: Interleukin-6 (IL-6) concentration will be measured in \[serum/plasma\] using \[laboratory assay\] and reported in \[unit\].
C-Reactive Protein Concentration [baseline and 4 weeks]: C-reactive protein (CRP) concentration will be measured in \[serum/plasma\] using \[laboratory method\] and reported in \[unit\].
Health-Related Quality of Life Measured Using the EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L) Index [baseline and 4 weeks]: 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.
Body Weight [Baseline and week 4]: Body weight will be measured using a digital weighing scale and reported in kilograms (kg).

Secondary outcomes

Body Mass Index [Baseline and week 4]: Body mass index (BMI) will be calculated as body weight in kilograms divided by height in meters squared and reported in kg/m². Body weight will be measured using \[weighing instrument\], and height will be measured using \[height measurement instrument\].
Muscle Mass [Baseline and week 4]: Muscle mass will be measured using \[measurement device and method\] and reported in \[kg or %\].
Mid-Upper Arm Circumference [Baseline and week 4]: Mid-upper arm circumference will be measured using a non-stretchable measuring tape at the midpoint between the acromion and olecranon and reported in centimeters (cm).

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

+Locations (2)

Facility	City	Country	Status
Nutrition Department, Universitas sumatera utara, Medan, Indonesia	Medan, North Sumatera	Indonesia	Recruiting
Nutrition Department, Universitas sumatera utara, Medan, Indonesia	Medan, North Sumatera	Indonesia	Recruiting