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CTRI Number  CTRI/2024/10/074853 [Registered on: 07/10/2024] Trial Registered Prospectively
Last Modified On: 22/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effect of turmeric with or without metformin on blood sugar control in prediabetic individuals  
Scientific Title of Study   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 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Milan Padhan 
Designation  Academic Senior Resident 
Affiliation  JIPMER, Puducherry 
Address  Clinical Pharmacology Dept, 3rd Floor Institute Block, JIPMER Puducherry Hospital, Gorimedu, Dhanvantari Nagar

Pondicherry
PONDICHERRY
605006
India 
Phone  8018198488  
Fax    
Email  milanpadhan12@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sandhiya S 
Designation  Additional Professor and Head 
Affiliation  JIPMER, Puducherry 
Address  Clinical Pharmacology Dept, 3rd Floor Institute Block, JIPMER Puducherry Hospital, Gorimedu, Dhanvantari Nagar

Pondicherry
PONDICHERRY
605006
India 
Phone  9443492922  
Fax    
Email  sandhiyaselvarajan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Milan Padhan 
Designation  Academic Senior Resident 
Affiliation  JIPMER, Puducherry 
Address  Clinical Pharmacology Dept, 3rd Floor Institute Block, JIPMER Puducherry Hospital, Gorimedu, Dhanvantari Nagar

Pondicherry
PONDICHERRY
605006
India 
Phone  08018198488  
Fax    
Email  milanpadhan12@gmail.com  
 
Source of Monetary or Material Support  
JIPMER Intramural Fund 
 
Primary Sponsor  
Name  JIPMER, Puducherry 
Address  JIPMER Puducherry Hospital, Gorimedu, Dhanvantari Nagar, Gorimedu, Dhanvantari Nagar, Puducherry, 605006.  
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Milan Padhan  JIPMER Hospital, Puducherry   Clinical Pharmacology Dept, 3rd Floor, Institute Block, JIPMER Puducherry Hospital
Pondicherry
PONDICHERRY 		 8018198488

milanpadhan12@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (Human studies) for Intervention studies, JIPMER Puducherry  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R730||Abnormal glucose,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Curcuma longa and Metformin  Tab. Curcuma longa 550 mg OD and Tab. Metformin 500 mg OD for 24 weeks 
Intervention  Curcuma longa and Placebo for Metformin  Tab. Curcuma longa 550 mg OD and Tab. Placebo for Metformin OD for 24 weeks 
Intervention  Metformin and Placebo for Curcuma longa  Tab. Metformin 500 mg OD and Tab. Placebo for Curcuma longa OD for 24 weeks 
Comparator Agent  Placebo for Curcuma longa and Placebo for Metformin  Tab. Placebo for Curcuma longa OD and Tab. Placebo for Metformin OD for 24 weeks 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Apparently healthy individuals aged greater 30 years of either gender with HbA1c between 5.7 and 6.4 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
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 weeks  12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
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 weeks  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 weeks  12 weeks and 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 weeks   12 weeks and 24 weeks  
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 weeks  24 weeks  
 
Target Sample Size   Total Sample Size="196"
Sample Size from India="196" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   15/10/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   The trial will be started after Postgraduate Research Monitoring Committee (PGRMC), the Institutional Ethics committee approval and CTRI registration. The study will be done in accordance with Indian Good Clinical Practice and ICMR ethical guidelines. After obtaining written informed consent, participants will be recruited at JIPMER through screening of high-risk populations, especially first-degree relatives of patients with type 2 diabetes mellitus as well as women with past history of gestational diabetes mellitus. The eligible participants will be randomized to receive any one of the following treatments using double dummy technique for a period of 6 months. • Group A: Tab. Curcuma longa 550 mg OD + Tab. Metformin 500 mg OD • Group B: Tab. Curcuma longa 550 mg OD + Tab. Placebo for Metformin OD • Group C: Tab. Metformin 500 mg OD + Tab. Placebo for Curcuma longa OD •   Group D: Tab. Placebo for Curcuma longa OD + Tab. Placebo for Metformin OD At baseline and at 12th weeks and 24th weeks of follow-up visits, 5 ml of blood sample will be collected using all aseptic precautions to assess HbA1c, fasting plasma glucose and postprandial blood glucose, serum insulin, liver and renal function test. Blood samples collected will be allowed to clot for 15-30 minutes and centrifuged at 2500 rpm for 10 minutes. About 1 ml of serum will be stored at -80 deg C and serum insulin level will be measured using chemiluminescence method. In all the three visits vascular function and exercise capacity will be assessed. The placebo formulations of Curcuma longa and metformin will be indistinguishable in terms of colour, size, shape with respect to the corresponding drugs. During the follow up visit those diagnosed with diabetes will be started on standard of care by the treating physicians and will not be followed up further. Periscope®, a non-invasive device (Genesis Medical Systems India) based on oscillometric principle will be used to measure arterial stiffness in supine position after 5 minutes of rest. Carotid femoral (aortic) 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 will be measured at baseline and at 12th weeks and 24th weeks. Exercise capacity of the patient will be assessed by Cardio Pulmonary Exercise Testing (CPET) machine (Quark CPET, Cosmed) at baseline and at 12th weeks and 24th weeks. It is a computer-controlled device whose role is to measure the levels of oxygen and carbon dioxide with the help of fast and selective breath analyzers. The detailed procedure of CPET will be explained to the patient and a demo will be shown to sensitize the patient to use the bicycle ergometer. Details like height, weight will be entered in the software and patient ID will be created. The CPET mode will be selected in the software and auto zero calibration is allowed to run for the breath analyzer. CPET is performed as symptom-limited bicycle ergometry in a sitting position. A continuously incrementing ramp protocol (increase of work rate, e.g., every 2–15 s) or minute-by-minute increments in 5–30 W/min steps to symptom-limited maximum of exercise is used as standard. CPET procedure is divided into 4 parts. Resting phase (2-3 min): Adaptation of respiration to the mask or mouthpiece including measurements of ECG (proper placement of leads is essential for a clean ECG signal) and blood pressure. Unloaded phase (“active baseline”; 2–3 min): Unloaded cycling with no added resistance (internal work rate depending on equipment: 0–15 watts) Incremental exercise phase (10 ± 2 min) Recovery phase (cool down period; 3–5 min): unloaded pedaling. The recordings are terminated and all leads and facial mask are disconnected from the patient. The primary parameters measured using flow sensor are oxygen uptake (VO2), carbon dioxide output (VCO2). Heart rate (HR). The facial mask will be disinfected before each test. The CPET will be repeated at 12th weeks and 24th weeks. HOMA-IR, QUICKI will be calculated using the formula after measuring the serum insulin levels. HOMA-IR = (FPI x FPG)/22.5 for insulin resistance QUICKI = 1/ (log FPI + log FPG) Adherence to drugs and adverse drugs reactions will be assessed from pill count, patient diary and by direct interactions during follow-up visits. 
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