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Effect of turmeric with or without metformin on blood sugar control in prediabetic individuals

Efficacy and safety of Curcuma longa either alone or in combination with metformin on glycemic status in prediabetes population: A Randomized, double-blinded, double-dummy, placebo-controlled, factorial design trial - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/10/074853
Enrollment
196
Registered
2024-10-07
Start date
Unknown
Completion date
Unknown
Last updated
2024-10-14

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

Conditions

Health Condition 1: R730- Abnormal glucose

Interventions

Intervention1: Curcuma longa and Metformin: Tab. Curcuma longa 550 mg OD and Tab. Metformin 500 mg OD for 24 weeks Intervention2: Curcuma longa and Placebo for Metformin: Tab. Curcuma longa 550 mg OD

Sponsors

JIPMER, Puducherry
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Apparently healthy individuals aged greater 30 years of either gender with HbA1c between 5.7 and 6.4

Exclusion criteria

Exclusion criteria: 1. BMI greater than 40 kg per m2 2. Those on drugs known to increase blood glucose levels like steroids, oral contraceptive pills etc and on herbal or other alternative system of medication. 3. Impaired liver function (AST or ALT elevated greater 2 times normal) 4. Renal insufficiency (GFR less than 60 ml per min) 5. Pregnant women and lactating mothers

Design outcomes

Primary

MeasureTime frame
To evaluate the efficacy of Curcuma longa and metformin alone and in combination as compared to placebo on modifying HbA1c level in prediabetes population at the end of 12 weeksTimepoint: 12 weeks

Secondary

MeasureTime frame
4. To evaluate the safety of Curcuma longa and metformin alone and in combination as compared to placebo in prediabetes population over a period of 24 weeksTimepoint: 24 weeks;To evaluate the effect of Curcuma longa and metformin alone and in combination as compared to placebo on exercise capacity in prediabetes population at the end of 12 weeks and 24 weeksTimepoint: 12 weeks and 24 weeks;To evaluate the effect of Curcuma longa and metformin alone and in combination as compared to placebo on vascular functions (carotid femoral Pulse Wave Velocity, brachial ankle pulse wave velocity, right and left brachial arterial stiffness index, right and left arterial stiffness index, ankle brachial index, aortic systolic/diastolic pressure, aortic augmentation pressure and aortic augmentation index) as compared to placebo in prediabetes population at the end of 12 weeks and 24 weeksTimepoint: 12 weeks and 24 weeks;To evaluate the efficacy of Curcuma longa and metformin alone and in combination as compared to placebo on glycemic status and insulin resistance in prediabetes population at the end of 12 weeks and 24 weeksTimepoint: 12 weeks and 24 weeks

Countries

India

Contacts

Public ContactDr Milan Padhan

JIPMER, Puducherry

sandhiyaselvarajan@gmail.com9443492922

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026