Pulmonary TuberculosisNCT07887724
Channa Striata and Curcuma Domestica Supplementation in Patients With Active Pulmonary Tuberculosis
A study testing CHANA STRIATA AND CURCUMA in people with Pulmonary Tuberculosis, run by DINA KEUMALA SARI at 2 sites in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Tuberculosis
- What is being tested?
- CHANA STRIATA AND CURCUMA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesIndonesia
- Study dates
- 1 Aug 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia2 sites, 2 recruiting
- Recruiting
Nutrition Department, Universitas sumatera utara, Medan, Indonesia
Medan, North Sumatera, 20132
Adelia Amelia, +62872387445, fauzanlubis18@gmail.com
- Recruiting
Nutrition Department, Universitas sumatera utara, Medan, Indonesia
Medan, North Sumatera
About this study
Official title: 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
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
- Being tested
- CHANA STRIATA AND CURCUMA, Maltodextrin (Placebo)
- Keywords
- Channa striata, Curcuma domestica, Nutritional Status, Inflammatory Markers, Quality of Life
- Medical subject headings
- Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHANA STRIATA AND CURCUMADietary supplement
Channa striata 5gr and curcuma 250mg
Maltodextrin (Placebo)Dietary supplement
Maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| Experimental : Channa Striata and Curcuma | Experimental | Channa striata 5gr and curcuma domestica rhizoma 250mg Receives: Dietary Supplement: CHANA STRIATA AND CURCUMA |
| Placebo | Placebo comparator | maltodekstrin Receives: Dietary Supplement: Maltodextrin (Placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interleukin-6 Concentration
Interleukin-6 (IL-6) concentration will be measured in [serum/plasma] using [laboratory assay] and reported in [unit].
Measured: 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].
Measured: 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.
Measured: baseline and 4 weeks
Body Weight
Body weight will be measured using a digital weighing scale and reported in kilograms (kg).
Measured: Baseline and week 4
Secondary outcomes (3)
Body Mass Index
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].
Measured: Baseline and week 4
Muscle Mass
Muscle mass will be measured using [measurement device and method] and reported in [kg or %].
Measured: Baseline and week 4
Mid-Upper Arm Circumference
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).
Measured: Baseline and week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start1 Aug 2026
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DINA KEUMALA SARI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, DINA KEUMALA SARI, Universitas Sumatera Utara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07887724
- Sponsor's protocol ID
- USU Tuberculosis Nutrition
- Status last verified
- Oct 2026
- First submitted
- 16 Jul 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07887724
- Acronym / sponsor ID
- USU Tuberculosis Nutrition
- Conditions
- Pulmonary Tuberculosis
- Keywords
- Channa striata, Curcuma domestica, Nutritional Status, Inflammatory Markers, Quality of Life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- DINA KEUMALA SARIUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 21 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental : Channa Striata and Curcuma | Experimental | Dietary Supplement: CHANA STRIATA AND CURCUMAChanna striata 5gr and curcuma domestica rhizoma 250mg |
| Placebo | Placebo comparator | Dietary Supplement: Maltodextrin (Placebo)maltodekstrin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHANA STRIATA AND CURCUMAChanna striata 5gr and curcuma 250mg | Dietary supplement | Experimental : Channa Striata and Curcuma |
| Maltodextrin (Placebo)Maltodextrin | Dietary supplement | Placebo |
Primary outcome
Interleukin-6 Concentration
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and week 4
Body weight will be measured using a digital weighing scale and reported in kilograms (kg).
3 secondary outcomes
Body Mass Index
Time frame: Baseline and week 4
Muscle Mass
Time frame: Baseline and week 4
Mid-Upper Arm Circumference
Time frame: Baseline and week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHANA STRIATA AND CURCUMA in people with Pulmonary Tuberculosis, run by DINA KEUMALA SARI at 2 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aprillia Kusuma Putri (+628116590096, aprilliakusuma0104@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interleukin-6 Concentration (time frame: baseline and 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.