Clinical trial NCT06794502: Butterfly Pea Flower (Clitoria Ternatea) for Adjuvant TB Treatment
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Tuberculosis (TB)
Tuberculosis Treatment Effectiveness
Keywords: Anti-inflammatory agents
Butterfly pea flower
Cytokines
Tuberculosis therapy
Clitoria ternatea
Lead sponsor: Universitas Muhammadiyah Semarang
Sponsor class: OTHER
First posted: 2025-01-27
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The interferon-gamma and interleukin-10 cytokines
timeFrame: From enrollment to the end of treatment at 2 months
measure: Hematology profiles
timeFrame: From enrollment to the end of treatment at 2 months
measure: Microscopic profiles of acid-fast bacilli (AFBs)
timeFrame: From enrollment to the end of treatment at 2 months
Secondary outcomes:
Other outcomes:
measure: Clinical symptoms and toxicity
timeFrame: From enrollment to the end of treatment at 2 months
Locations:
city: Pangkalan Bun
country: Indonesia
facility: West Kotawaringin Health Department
state: Central Kalimantan
city: Pangkalan Bun
country: Indonesia
facility: Mendawai Community Health Center
state: Central Kalimantan
Study officials:
affiliation: Universitas Muhammadiyah Semarang
name: Sri Darmawati, Professor
role: PRINCIPAL_INVESTIGATOR
References: