| CTRI Number |
CTRI/2018/09/015586 [Registered on: 05/09/2018] Trial Registered Prospectively |
| Last Modified On: |
24/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to assess effects of Nutraceutical formulations in Pre-diabetic Subjects. |
|
Scientific Title of Study
|
A Prospective, Randomized, Double Blinded, Placebo Controlled, Parallel
Group, Proof of Concept Study to Assess the Effect of Nutraceutical Formulations in Pre-diabetic Subjects
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AM_CX_2018_001_V-1_dated_30-Jul-2018 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shrikant Deshpande |
| Designation |
Proprietor- Ashirwad Hospital and Research Centre |
| Affiliation |
Ashirwad Hospital and Research Centre |
| Address |
Ashirwad Hospital and Research Centre,
Clinical Research Department, Ground Floor, Research room,
Maratha Section, Near Jijamata Udyan,
Ulhasnagar-421004, Maharashtra, India
Thane
MAHARASHTRA
421 004
India |
| Phone |
91-251-2587006 |
| Fax |
|
| Email |
writetoshrikant@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Partha Chatterjee |
| Designation |
Head-Clinical Research and CTSM |
| Affiliation |
SIRO Clinpharm pvt ltd |
| Address |
Kalpataru Prime, 1st Floor, Unit no. 3 and 4, Plot no. D-3, Road no.16, Wagle Industrial Estate, Thane(West)- 400604,Maharashtra India
Thane
MAHARASHTRA
400604
India |
| Phone |
22-61088000 |
| Fax |
22-61088081 |
| Email |
partha.chatterjee@siroclinpharm.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Partha Chatterjee |
| Designation |
Head-Clinical Research and CTSM |
| Affiliation |
SIRO Clinpharm pvt ltd |
| Address |
Kalpataru Prime, 1st Floor, Unit no. 3 and 4, Plot no. D-3, Road no.16, Wagle Industrial Estate, Thane(West)- 400604,Maharashtra India
Thane
MAHARASHTRA
400604
India |
| Phone |
22-61088000 |
| Fax |
22-61088081 |
| Email |
partha.chatterjee@siroclinpharm.com |
|
|
Source of Monetary or Material Support
|
| Amway India Enterprises Pvt Ltd, Plot No 84, sector 32, Gurgaon, Haryana – 122001 |
|
|
Primary Sponsor
|
| Name |
Amway India Enterprises Pvt Ltd |
| Address |
Plot No 84, sector 32
Gurgaon, Haryana – 122001 |
| Type of Sponsor |
Other [Nutraceutical] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Siro Clinpharm Pvt Ltd |
Kalpataru Prime, 1st Floor, Unit no. 3 and 4, Plot no. D-3, Road no.16, Wagle Industrial Estate, Thane(West)- 400604,Maharashtra India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shrikant Deshpande |
Ashirwad Hospital & Research Centre |
Clinical Research Department, Ground Floor, Research room,
Maratha Section, Near Jijamata Udyan,
Ulhasnagar-421004, Maharashtra, India
Thane
MAHARASHTRA |
91-251-2587006
writetoshrikant@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ashirwad Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Pre-Diabetes |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nutraceutical-1,2,3 |
2 tablets twice daily to be consumed orally for 30 days: Botanical formulation of extracts from Cinnamon, Moringa, Bitter Melon, Fenugreek, Gymnema and Ginger |
| Comparator Agent |
Placebo |
2 tablets twice daily to be consumed orally for 30 days |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female aged between 25-65 years
2. Subjects with BMI of ≥23 to ≤ 35 kg/m2
3. Subject with a HbA1c levels of 5.7-6.4% (39-46 mmol/mol) as per the
American Diabetes Association at the time of screening
4. Subjects with liver (alanine transaminase, aspartate transaminase, total
and direct bilirubin, gamma glutamyl transferase, alkaline phosphatase,
total proteins, and albumin) and renal (serum creatinine and blood urea
nitrogen) function parameters within normal laboratory reference range at
screening
5. Females of childbearing potential must have a negative serum pregnancy
test (human chorionic gonadotropin, beta subunit [β-hCG]) at screening
6. Males and females of childbearing potential willing to practice
appropriate birth control during the entire duration of the study.
Appropriate birth control is defined in the study as any medically
recommended method (or combination of methods) except oral birth
control pills as per standard of care
7. Subject is willing to provide written informed consent
8. Subject is willing, able and likely to comply with all study procedures and
restrictions
|
|
| ExclusionCriteria |
| Details |
1. Subject with a history of diabetes mellitus (type 1/ type 2/ gestational/secondary etc.)
2. Subject has used any anti-diabetic medication for blood sugar control or other medical conditions (e.g. metformin in polycystic ovarian disease)any time during the past 6 months
3. Subject is taking medications known to interfere with glucose metabolism e.g. systemic corticosteroids, protease inhibitors, antidepressants, or antipsychotics) or any other medications in the opinion of investigator that
may interfere with study outcomes
4. Subjects with a history of use of other herbal or nutritional supplements that modify glucose absorption and/or metabolism in the past 6 months
5. Subjects with a history of use of weight loss drugs (orlistat, lorcaserin, phentermine-topiramate, naltrexone-bupropion etc) in the past 6 months.
6. Subject has had a weight loss or gain of greater ≥5% of body weight in the 6 months prior to screening.
7. Hemoglobin levels of <11 g/dl
8. Subject with a history of clotting/bleeding disorders such as hemophilia,Von Willebrand disease, disseminated intravascular coagulation, vitamin K deficiency or subjects who required blood transfusion in the past 3 months.
9. Subject with history of significant renal, hepatic, cardiovascular, hematologic, metabolic, ophthalmologic, respiratory, gastrointestinal,
cerebrovascular, neurologic, endocrine dysfunction, malignancy, or any other significant medical illness or disorder which, in the judgment of the investigator could interfere with the study or require treatment(s) which might interfere with study or which may pose risk to the patient
10. History of drug abuse or alcohol consumption (>20 g/day in women and >30 g/day in men) and smoking (>5 pack-years cigarettes)
11. History of participation in other interventional studies within last 60 days
12. History of blood donation within last 30 days
13. Subjects with inadequate peripheral venous access, such that intravenous catheterization for serial blood collection is difficult.
14. Subject is pregnant or breast-feeding at the time of screening, or planning to be pregnant during the study
15. Subject has known allergies to the herbal products or allergy to any of the components of the study product
16. Any other condition, that in the investigator’s judgment, might interfere
with study objectives
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Safety : number of subjects reporting any AE, treatment emergent AE (TEAE), any serious AE (SAE), any study product-related AE, any study product related SAE, and discontinuations due to AE.
Efficacy endpoints:
change in blood glucose levels based on OGTT after 30 days of treatment with study products
change in fructosamine, fasting plasma glucose level and serum Insulin levels, fasting serum lipids and body weight from Baseline to 30 days between the treatment arms |
30 days of study product administration |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
Final Enrollment numbers achieved (Total)= "56"
Final Enrollment numbers achieved (India)="56" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/09/2018 |
| Date of Study Completion (India) |
14/11/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a randomized, double blind, parallel group, placebo-controlled single-centre trial to study the safety and efficacy 3 botanical nutraceutical formulations to be consumed twice daily for a period of 30 days in 56 pre-diabetic subjects in India. The available literature suggests that the natural extracts from certain plants (cinnamon, fenugreek, ginger etc.) have the potential to improve the blood glucose levels, hemoglobin A1c levels, and other components of metabolic syndrome such as dyslipidemia and obesity, when combined with lifestyle measures. Currently, there is no standard-of-care for prediabetic subjects, except diet and lifestyle modifications. It is hypothesized that botanical formulations containing combinations of natural extracts from such plants i.e. drum stick, bitter melon, cinnamon, fenugreek, gurmar, ginger may benefit the glucose and lipid profile as well as body weight in prediabetics. |