Butterfly Pea Flower (Clitoria Ternatea) for Adjuvant TB Treatment

January 20, 2025 updated by: Maya Dian Rakhmawatie, Universitas Muhammadiyah Semarang

Interferon Gamma, Interleukin-10, Hematology and Microscopic Profile of Tuberculosis Patients With Treatment Combination of Anti-Tuberculosis and Butterfly Pea Flowers Extract (Clitoria Ternatea)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • Central Kalimantan
      • Pangkalan Bun, Central Kalimantan, Indonesia, 74112
        • West Kotawaringin Health Department
      • Pangkalan Bun, Central Kalimantan, Indonesia, 74115
        • Mendawai Community Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Butterfly pea flower extract and anti-TB regimens
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.
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 Names:
  • Decocta extract of Clitoria ternatea
  • Butterfly pea flower extract
Other: Anti-TB regimens monotherapy
The patients in anti-TB monotherapy group (Group 2) were given a regimen consisting of rifampicin, isoniazid, pyrazinamide, and ethambutol 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The interferon-gamma and interleukin-10 cytokines
Time Frame: From enrollment to the end of treatment at 2 months
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
Time Frame: From enrollment to the end of treatment at 2 months
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)
Time Frame: From enrollment to the end of treatment at 2 months
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.
From enrollment to the end of treatment at 2 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical symptoms and toxicity
Time Frame: From enrollment to the end of treatment at 2 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitas Muhammadiyah Semarang

Investigators

  • Principal Investigator: Sri Darmawati, Professor, Universitas Muhammadiyah Semarang

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2024

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

August 31, 2024

Study Registration Dates

First Submitted

January 20, 2025

First Submitted That Met QC Criteria

January 20, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 20, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMuhammadiyahSemarang
  • 108/E5/PG.02.00.PL/2024 (Other Grant/Funding Number: Ministry of Research, Technology, and Higher Education of the Republic of Indonesia)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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