Tuberculosis (TB)Early Phase 1NCT06794502
Butterfly Pea Flower (Clitoria Ternatea) for Adjuvant TB Treatment
A Early Phase 1 study testing Herbal medicine and Tuberculosis (TB) treatment in people with Tuberculosis (TB) and Tuberculosis Treatment Effectiveness, run by Universitas Muhammadiyah Semarang at 2 sites in Indonesia.
Trial summary
The goal of this clinical trial is to learn if butterfly pea flowers (Clitoria ternatea) decocta extract works to treat as adjuvant therapy for tuberculosis in adults. It will also learn about the safety of butterfly pea flowers decocta extract. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Tuberculosis (TB), Tuberculosis Treatment Effectiveness
- What is being tested?
- Herbal medicine and Tuberculosis (TB) treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesIndonesia
- Study dates
- 14 Mar 2024to 31 Aug 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pulmonary TB patients were positive based on the results of the Rapid Molecular Test GeneXpert M. tuberculosis (MTB)/Rifampicin (RIF),
- Patients who were undergoing the initiation phase of anti-TB treatment for the first time,
- Non-Multi Drug Resistant (MDR)/Extensively-Drug Resistant (XDR) TB patients with first-line anti-TB treatment (rifampicin, isoniazid, pyrazinamide, and ethambutol),
- Patients >18 years old,
- Patients who were willing to become research subjects and signed informed consent.
Who cannot join
- TB patients with Human Immunodeficiency Virus (HIV) positive,
- Patients who did not complete the study,
- Patients with non-compliance in taking medication,
- Patients with comorbidities (autoimmune and cancer),
- Smoking patients,
- Patients contraindicated in using butterfly pea flower extract.
Trial locations and contacts
2 sites in 1 country.
Indonesia2 sites
West Kotawaringin Health Department
Pangkalanbuun, Central Kalimantan, 74112
Mendawai Community Health Center
Pangkalanbuun, Central Kalimantan, 74115
About this study
Official title: Interferon Gamma, Interleukin-10, Hematology and Microscopic Profile of Tuberculosis Patients With Treatment Combination of Anti-Tuberculosis and Butterfly Pea Flowers Extract (Clitoria Ternatea)
The goal of this clinical trial is to learn if butterfly pea flowers (Clitoria ternatea) decocta extract works to treat as adjuvant therapy for tuberculosis in adults. It will also learn about the safety of butterfly pea flowers decocta extract.
The main questions it aims to answer are:
Read more
- Does butterfly pea flower extract as an adjunct TB drug therapy drug affect the profiles of interferon gamma and interleukin-10 of people with tuberculosis?
- Does butterfly pea flower extract as an adjunct TB drug therapy drug affect the hematology profiles of people with tuberculosis?
- Does butterfly pea flower extract as an adjunct TB drug therapy drug affect the clinical symptoms and acid-fast bacilli microscopic analysis of people with tuberculosis?
- What medical problems do participants have when taking butterfly pea flower decocta extracts?
Researchers will compare butterfly pea flower extract as an adjunct TB drug therapy to monotherapy TB drugs to see if adjuvant butterfly pea flowers extract works to treat tuberculosis infection in 2-month initiation phase therapy.
Participants will:
- Take drug butterfly pea flower extract plus TB regimen drugs consisting of rifampicin, isoniazid, pyrazinamide, and ethambutol or monotherapy TB regimen drugs only every day for 2 months
- Willing to undergo treatment monitoring and visit the clinic once every 2 weeks for checkups and tests
- Keep a diary of their symptoms and the number of times they use a butterfly pea flower decocta extract
- Being tested
- Herbal medicine, Tuberculosis (TB) treatment
- Keywords
- Anti-inflammatory agents, Butterfly pea flower, Cytokines, Tuberculosis therapy, Clitoria ternatea
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herbal medicineDrug
Also called Decocta extract of Clitoria ternatea, Butterfly pea flower extract
Herbal medicine from butterfly pea flower decocta extract is used as an additional TB drug therapy regimen for active TB patients during the initiation phase of treatment for 2 months.
Tuberculosis (TB) treatmentOther
The patients in anti-TB monotherapy group (Group 2) were given a regimen consisting of rifampicin, isoniazid, pyrazinamide, and ethambutol for 2 months. This group did not receive any additional therapy.
| Study group | Role | What they receive |
|---|---|---|
| Butterfly pea flower extract and anti-TB regimens | Active comparator | The adjuvant therapy group of Tuberculosis patients (Group 1) were given an herbal medicine butterfly pea flower extract of 40 mL/day and anti-TB regimen for 2 months. Receives: Drug: Herbal medicine |
| Anti-TB regimens monotherapy | Other | The patients in anti-TB monotherapy group (Group 2) were given a regimen consisting of rifampicin, isoniazid, pyrazinamide, and ethambutol for 2 months. Receives: Other: Tuberculosis (TB) treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The interferon-gamma and interleukin-10 cytokines
Evaluation of the success of anti-TB therapy and anti-TB plus adjuvant butterfly pea flower therapy was carried out after completion of the 2-month initiation phase of treatment. Change Factor Analysis (CFA) for each cytokines parameter (interferon gamma or interleukin 10) was compared between the two treatment groups. Change Factor Analysis (CFA) for each therapy group was used to see whether there was an increase or decrease in cytokine concentrations after 2 months of therapy. The value was calculated from the concentration of each cytokine after treatment minus the concentration before treatment and divided by the concentration before treatment. After obtaining the CFA value for each group, the results between the groups were compared using independent t-test analysis.
Measured: From enrollment to the end of treatment at 2 months
Hematology profiles
For hematological profile analysis, the Change Factor Analysis (CFA) for each parameter, namely Hb (g/dL), leukocytes and platelets (cells/µL), hematocrit and granulocytes (%), and Erythrocyte Sedimentation Rate (ESR) (mm/hour) was calculated for each treatment group. Change Factor Analysis (CFA) in each therapy group was used to see whether there was an increase or decrease in the concentration of each hematological parameter after 2 months of therapy. This CFA value is calculated from the concentration of each hematological profile after treatment minus the concentration before treatment and divided by the concentration before treatment. After obtaining the CFA value for each hematology parameter in each group, the results between butterfly pea flower extract plus anti TB-regimen groups and monotherapy anti-TB regimen were compared using independent t test analysis.
Measured: From enrollment to the end of treatment at 2 months
Microscopic profiles of acid-fast bacilli (AFBs)
Microscopic analysis of Mycobacterium tuberculosis was carried out using Ziehl-Nielsen staining of sputum from TB patients in all therapy groups. Microscopic examination was carried out before and after treatment. The results of the examination are evaluated descriptively by seeing whether there is a decrease in the positive value of the number of colonies found during the examination.
Measured: From enrollment to the end of treatment at 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start14 Mar 2024
- Primary completion30 Jun 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis (TB)Studies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Muhammadiyah Semarang
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maya Dian Rakhmawatie, Universitas Muhammadiyah Semarang
- Investigators
- Sri Darmawati, Professor, Principal investigator, Universitas Muhammadiyah Semarang
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06794502
- Sponsor's protocol ID
- UMuhammadiyahSemarang
- Other IDs
- 108/E5/PG.02.00.PL/2024
- Status last verified
- Jan 2025
- First submitted
- 20 Jan 2025
- Last updated
- 27 Jan 2025
- 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 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interferon Gamma, Interleukin-10, Hematology and Microscopic Profile of Tuberculosis Patients With Treatment Combination of Anti-Tuberculosis and Butterfly Pea Flowers Extract (Clitoria Ternatea)
- ClinicalTrials.gov ID
- NCT06794502
- Acronym / sponsor ID
- UMuhammadiyahSemarang
- Keywords
- Anti-inflammatory agents, Butterfly pea flower, Cytokines, Tuberculosis therapy, Clitoria ternatea
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Universitas Muhammadiyah SemarangUniversity, hospital or other
- Study start
- 14 Mar 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 27 Jan 2025 (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.
The goal of this clinical trial is to learn if butterfly pea flowers (Clitoria ternatea) decocta extract works to treat as adjuvant therapy for tuberculosis in adults. It will also learn about the safety of butterfly pea flowers decocta extract.
The main questions it aims to answer are:
- Does butterfly pea flower extract as an adjunct TB drug therapy drug affect the profiles of interferon gamma and interleukin-10 of people with tuberculosis?
- Does butterfly pea flower extract as an adjunct TB drug therapy drug affect the hematology profiles of people with tuberculosis?
- Does butterfly pea flower extract as an adjunct TB drug therapy drug affect the clinical symptoms and acid-fast bacilli microscopic analysis of people with tuberculosis?
- What medical problems do participants have when taking butterfly pea flower decocta extracts?
Researchers will compare butterfly pea flower extract as an adjunct TB drug therapy to monotherapy TB drugs to see if adjuvant butterfly pea flowers extract works to treat tuberculosis infection in 2-month initiation phase therapy.
Participants will:
- Take drug butterfly pea flower extract plus TB regimen drugs consisting of rifampicin, isoniazid, pyrazinamide, and ethambutol or monotherapy TB regimen drugs only every day for 2 months
- Willing to undergo treatment monitoring and visit the clinic once every 2 weeks for checkups and tests
- Keep a diary of their symptoms and the number of times they use a butterfly pea flower decocta extract
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Butterfly pea flower extract and anti-TB regimens | Active comparator | Drug: Herbal medicineThe adjuvant therapy group of Tuberculosis patients (Group 1) were given an herbal medicine butterfly pea flower extract of 40 mL/day and anti-TB regimen for 2 months. |
| Anti-TB regimens monotherapy | Other | Other: Tuberculosis (TB) treatmentThe patients in anti-TB monotherapy group (Group 2) were given a regimen consisting of rifampicin, isoniazid, pyrazinamide, and ethambutol for 2 months. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pulmonary TB patients were positive based on the results of the Rapid Molecular Test GeneXpert M. tuberculosis (MTB)/Rifampicin (RIF),
- Patients who were undergoing the initiation phase of anti-TB treatment for the first time,
- Non-Multi Drug Resistant (MDR)/Extensively-Drug Resistant (XDR) TB patients with first-line anti-TB treatment (rifampicin, isoniazid, pyrazinamide, and ethambutol),
- Patients >18 years old,
- Patients who were willing to become research subjects and signed informed consent.
Key exclusion criteria (6 listed)
- TB patients with Human Immunodeficiency Virus (HIV) positive,
- Patients who did not complete the study,
- Patients with non-compliance in taking medication,
- Patients with comorbidities (autoimmune and cancer),
- Smoking patients,
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 |
|---|---|---|
| Herbal medicineAlso: Decocta extract of Clitoria ternatea, Butterfly pea flower extractHerbal medicine from butterfly pea flower decocta extract is used as an additional TB drug therapy regimen for active TB patients during the initiation phase of treatment for 2 months. | Drug | Butterfly pea flower extract and anti-TB regimens |
| Tuberculosis (TB) treatmentThe patients in anti-TB monotherapy group (Group 2) were given a regimen consisting of rifampicin, isoniazid, pyrazinamide, and ethambutol for 2 months. This group did not receive any additional therapy. | Other | Anti-TB regimens monotherapy |
Primary outcome
The interferon-gamma and interleukin-10 cytokines
Time frame: From enrollment to the end of treatment at 2 months
Evaluation of the success of anti-TB therapy and anti-TB plus adjuvant butterfly pea flower therapy was carried out after completion of the 2-month initiation phase of treatment. Change Factor Analysis (CFA) for each cytokines parameter (interferon gamma or interleukin 10) was compared between the two treatment groups. Change Factor Analysis (CFA) for each therapy group was used to see whether there was an increase or decrease in cytokine concentrations after 2 months of therapy. The value was calculated from the concentration of each cytokine after treatment minus the concentration before treatment and divided by the concentration before treatment. After obtaining the CFA value for each group, the results between the groups were compared using independent t-test analysis.
Hematology profiles
Time frame: From enrollment to the end of treatment at 2 months
For hematological profile analysis, the Change Factor Analysis (CFA) for each parameter, namely Hb (g/dL), leukocytes and platelets (cells/µL), hematocrit and granulocytes (%), and Erythrocyte Sedimentation Rate (ESR) (mm/hour) was calculated for each treatment group. Change Factor Analysis (CFA) in each therapy group was used to see whether there was an increase or decrease in the concentration of each hematological parameter after 2 months of therapy. This CFA value is calculated from the concentration of each hematological profile after treatment minus the concentration before treatment and divided by the concentration before treatment. After obtaining the CFA value for each hematology parameter in each group, the results between butterfly pea flower extract plus anti TB-regimen groups and monotherapy anti-TB regimen were compared using independent t test analysis.
Microscopic profiles of acid-fast bacilli (AFBs)
Time frame: From enrollment to the end of treatment at 2 months
Microscopic analysis of Mycobacterium tuberculosis was carried out using Ziehl-Nielsen staining of sputum from TB patients in all therapy groups. Microscopic examination was carried out before and after treatment. The results of the examination are evaluated descriptively by seeing whether there is a decrease in the positive value of the number of colonies found during the examination.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
Related trials for Tuberculosis (TB)
Not yet recruitingPhase 2
Re-evaluating the Duration in Children of TB Treatment
Tuberculosis
Active, not recruitingPhase 3
Protecting Households On Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients
Tuberculosis, MDR
RecruitingPhase 2
Evaluating the Safety and Immunogenicity of MTBVAC
HIV I Infection, Tuberculosis
RecruitingObservational study
Molecular Epidemiology, Strains Genotyping of Multi-drug Resistant Tuberculosis Circulating in Central Africa Region
Multidrug-resistant Tuberculosis (MDR-TB)
RecruitingObservational study
Training Protocol on the Natural History of Tuberculosis
Mycobacterium Infections, Tuberculosis, Multidrug-Resistant
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. This study is not recruiting at the moment.
Sri Darmawati, Professor principal investigator
Universitas Muhammadiyah Semarang
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Herbal medicine and Tuberculosis (TB) treatment in people with Tuberculosis (TB) and Tuberculosis Treatment Effectiveness, run by Universitas Muhammadiyah Semarang 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 27 Jan 2025. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The interferon-gamma and interleukin-10 cytokines (time frame: From enrollment to the end of treatment at 2 months). The study lists 3 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 27 Jan 2025.