NCT06794502CompletedEarly phase 1
Butterfly Pea Flower (Clitoria Ternatea) for Adjuvant TB Treatment
Interferon Gamma, Interleukin-10, Hematology and Microscopic Profile of Tuberculosis Patients With Treatment Combination of Anti-Tuberculosis and Butterfly Pea Flowers Extract (Clitoria Ternatea)
Source: ClinicalTrials.gov · Last updated 27 Jan 2025
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 28 (actual)
- First submitted
- 20 Jan 2025
- Start date
- 14 Mar 2024
- Primary completion date
- 30 Jun 2024
- Lead sponsor
- Universitas Muhammadiyah Semarang
- Diseases
- Tuberculosis
- NCT number
- NCT06794502
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 28
- From 14 Mar 2024 to the primary completion date, 30 Jun 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with non-compliance in taking medication,
Other illness
- TB patients with Human Immunodeficiency Virus (HIV) positive,
- Patients with comorbidities (autoimmune and cancer),
Other
- Patients who did not complete the study,
- Smoking patients,
- Patients contraindicated in using butterfly pea flower extract.
Who the study is looking for
- 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.
Age in the registry: 18 years to 69 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| West Kotawaringin Health Department Coordinator of this site? Confirm its status | Pangkalanbuun | Indonesia | Unknown status |
| Mendawai Community Health Center Coordinator of this site? Confirm its status | Pangkalanbuun | Indonesia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.