Effect of Shigru (Moringa oleifera) Leaf Powder as an Add-on to Standard of Care in Metabolic Syndrome

Open-Label, Randomized Controlled Trial Protocol to Evaluate the Efficacy and Safety of Shigru (Moringa oleifera) Leaf Powder as an Add-on to Standard of Care for Glyeemic Control in Patients with Metabolic Syndrome at AIIMS Bhopal

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/12/098814

Enrollment

110

Registered

2025-12-10

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-12

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

Conditions

Health Condition 1: E889- Metabolic disorder, unspecified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Adults aged 30 to 65 years visiting outpatient department of AIIMS Bhopal Diagnosed with metabolic syndrome and having HbA1C between 6.5 to 8.0. Patients maintaining stable health conditions and not requiring any acute or long term medication for hypertension, dyslipidemia or obesity management. Willing to comply with protocol and follow up Provide informed written consent

Exclusion criteria

Exclusion criteria: Patients receiving oral hypoglycemic medications other than glimepiride or metformin Patients receiving any medications such as antihypertensive, obesity, and hyperlipidemia drugs. Severe Cardiac or hepatic or renal disease Acute cases with Diabetic complications such as ketoacidosis Any malignancy Pregnant or lactating women Allergic to herbal supplements Already using Moringa or any similar herbal interventions Living outside Bhopal

Design outcomes

Primary

Measure	Time frame
Mean change in Glycemic Markers (HbA1c)Timepoint: From baseline (day 0) to 12 weeks	—

Secondary

Measure	Time frame
Fasting Blood GlucoseTimepoint: From baseline (day 0) to 12 weeks;Postprandial Blood GlucoseTimepoint: From baseline (day 0) to 12 weeks;Serum Insulin (HOMA-IR)Timepoint: From baseline (day 0) to 12 weeks;C-peptideTimepoint: From baseline (day 0) to 12 weeks;WeightTimepoint: From baseline (day 0) to 12 weeks;Waist-Hip RatioTimepoint: From baseline (day 0) to 12 weeks;Systolic and diastolic Blood PressureTimepoint: From baseline (day 0) to 12 weeks;Lipid ProfileTimepoint: From baseline (day 0) to 12 weeks;High-sensitivity C-reactive Protein (hs-CRP)Timepoint: From baseline (day 0) to 12 weeks;Liver Function TestsTimepoint: From baseline (day 0) to 12 weeks;Renal Function TestsTimepoint: From baseline (day 0) to 12 weeks	—

Measure

Time frame

Fasting Blood GlucoseTimepoint: From baseline (day 0) to 12 weeks;Postprandial Blood GlucoseTimepoint: From baseline (day 0) to 12 weeks;Serum Insulin (HOMA-IR)Timepoint: From baseline (day 0) to 12 weeks;C-peptideTimepoint: From baseline (day 0) to 12 weeks;WeightTimepoint: From baseline (day 0) to 12 weeks;Waist-Hip RatioTimepoint: From baseline (day 0) to 12 weeks;Systolic and diastolic Blood PressureTimepoint: From baseline (day 0) to 12 weeks;Lipid ProfileTimepoint: From baseline (day 0) to 12 weeks;High-sensitivity C-reactive Protein (hs-CRP)Timepoint: From baseline (day 0) to 12 weeks;Liver Function TestsTimepoint: From baseline (day 0) to 12 weeks;Renal Function TestsTimepoint: From baseline (day 0) to 12 weeks

—

Countries

India

Contacts

Public ContactDr Danish Javed

All India Institute of Medical Sciences Bhopal

danish.ayush@aiimsbhopal.edu.in9654978285

Outcome results