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| ID | Type | Description | Link |
|---|---|---|---|
| 108/E5/PG.02.00.PL/2024 | Other Grant/Funding Number | Ministry of Research, Technology, and Higher Education of the Republic of Indonesia |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Herbal medicine | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Clinical symptoms and toxicity | Evaluation of clinical symptoms is carried out before and after therapy, by looking at whether there is an improvement in the symptoms of fever, cough, shortness of breath in TB patients. Hepatic toxicity was evaluated by observing whether jaundice occurred or not. | From enrollment to the end of treatment at 2 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sri Darmawati, Professor | Universitas Muhammadiyah Semarang | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West Kotawaringin Health Department | Pangkalanbuun | Central Kalimantan | 74112 | Indonesia | ||
| Mendawai Community Health Center |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| D008517 | Phytotherapy |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
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|
| Tuberculosis (TB) treatment | Other | 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. |
|
| From enrollment to the end of treatment at 2 months |
| Pangkalanbuun |
| Central Kalimantan |
| 74115 |
| Indonesia |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |