NCT06794502

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)

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Universitas Muhammadiyah Semarang · Academic / Other
• Sex: All
• Age: 18 Years – 69 Years
• Healthy volunteers: Not accepted

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

Conditions

• Tuberculosis (TB)
• Tuberculosis Treatment Effectiveness

Interventions

Type	Name	Description
DRUG	Herbal medicine	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.
OTHER	Tuberculosis (TB) treatment	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.

Timeline

• Start date: 2024-03-14
• Primary completion: 2024-06-30
• Completion: 2024-08-31
• First posted: 2025-01-27
• Last updated: 2025-01-27

Locations

2 sites across 1 country: Indonesia