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The Effect of Rosella (Hibiscus sabdariffa Linn) in Patients with Type 2 Diabetes Mellitus

The Effect of Rosella (Hibiscus sabdariffa Linn)in Patients with Type 2 Diabetes Mellitus : A Double-blinded Randomized Controlled Trial.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20241012012
Enrollment
60
Registered
2024-10-12
Start date
2019-06-22
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

type 2 diabetes mellitus glucose, Hibiscus sabdariffa Linn, HOMA-IR, insulin, lipid profiles, Rosella, type 2 diabetes, uncoupling protein 2

Interventions

In this research, we devided samples in two groups. The first group is called intervention group that received Rosella capsules ( contain 500 mg Hibiscus sabdariffa Linn flower extract) and the secon
Experimental Dietary Supplement
Rosella (Hibiscus sabdariffa Linn) intervention

Sponsors

Research Fund Management Institute of the Republic of Indonesia or Lembaga Pengelola Dana Pendidikan (LPDP) Republik Indonesia and Ministry of Research, Technology, and Higher Education of Republic of Indonesia or Kementrian Riset dan Teknologi Pendidikan Tinggi Republik Indonesia that funded the study and Universitas Gadjah Mada
Lead Sponsor

Eligibility

Sex/Gender
All
Age
35 Years to 65 Years

Inclusion criteria

Inclusion criteria: T2DM patients who are willing to become samples by signing an informed consent, able to communicate well, without complications of kidney disease and heart disease (examined by a doctor), aged 35-65 years (adults-elderly), taking drugs that are same type, dose / amount and frequency until the study was completed, not pregnant and breastfeeding.

Exclusion criteria

Exclusion criteria: before the intervention was given, the patient received insulin injection from the treating doctor, suffered from a heart with a heart ring installed, suffered from angina pectoris, received additional medical drugs, his fasting blood glucose level became normal, the patient died. Withdrawal criteria: patients died during the study, withdrew during data collection, patient adherence to taking Rosella capsules <80% during the study, suffered from infections and abscesses, increased diabetes medication (dose and frequency) during the study, drank tea. herbs or herbs, did not follow the research protocol

Design outcomes

Primary

MeasureTime frame
blood pressure, fasting glucose level, insulin level, lipid profiles level at 2 months after end of the intervention Blood pressure measured using a stethoscope, glucose levels is by GOD-PAP method, insulin level using by ELISA and lipid profiles defined with CHOD-PAP method and GPO-PAP method

Secondary

MeasureTime frame
Nutritional status, activity, food intake, HOMA-IR, HOMA-beta at 2 months after end of the intervention Nutritional status use Stadiometer and body scale, activity use a GPAQ Questonnaire, Food intake use a SQ-FFQ, HOMA-IR and HOMA-beta use a HOMA Calculator 2.2.3 Version

Countries

Indonesia

Contacts

Public ContactDwi Sarbini

Universitas Gadjah Mada

ds182@ums.ac.id6287764908261

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026