Butterfly Pea Flower (Clitoria Ternatea) for Adjuvant TB Treatment

Universitas Muhammadiyah Semarang

Status and phase: Completed; Early Phase 1

Conditions: Tuberculosis (TB); Tuberculosis Treatment Effectiveness

Treatments: Drug: Herbal medicine; Other: Tuberculosis (TB) treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT06794502

108/E5/PG.02.00.PL/2024 (Other Grant/Funding Number)

UMuhammadiyahSemarang

Details and patient eligibility

About

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

Enrollment: 28 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 2 patient groups

Butterfly pea flower extract and anti-TB regimens

Active Comparator group

Description:

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.

Treatment:

Drug: Herbal medicine

Anti-TB regimens monotherapy

Other group

Description:

The patients in anti-TB monotherapy group (Group 2) were given a regimen consisting of rifampicin, isoniazid, pyrazinamide, and ethambutol for 2 months.

Treatment:

Other: Tuberculosis (TB) treatment