| CTRI Number |
CTRI/2026/03/105708 [Registered on: 09/03/2026] Trial Registered Prospectively |
| Last Modified On: |
13/08/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to Assess Effect of Taking Glucophil® before Food on Blood Sugar Levels. |
|
Scientific Title of Study
|
An Open Label, Prospective, Non-Randomised, Comparative, Two Arm Clinical Study to Evaluate the Effect of Pre-Meal Supplementation with Glucophil® of K.-W. Pfannenschmidt GmbH on Carbohydrate Metabolism Parameters Post High Carbohydrate Meal in Euglycemic and Prediabetic Adult Subjects |
| Trial Acronym |
NIL |
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| AHC/MET/093/25 Version 03 27Apr26 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr VT Sriraam |
| Designation |
Investigator |
| Affiliation |
Raam Clinic |
| Address |
Room No 1, Department of General Medicine,
Division of Research and Development,
No 128, Shakthy Flats, NTR Garden Street,
Flats 01 and 02, Ground Floor,
Rangarajapuram Main Road, Kodambakkam
Chennai
TAMIL NADU
600024
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr VT Sriraam |
| Designation |
Investigator |
| Affiliation |
Raam Clinic |
| Address |
Room No 1, Department of General Medicine,
Division of Research and Development,
No 128, Shakthy Flats, NTR Garden Street,
Flats 01 and 02, Ground Floor,
Rangarajapuram Main Road, Kodambakkam
TAMIL NADU
600024
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr VT Sriraam |
| Designation |
Investigator |
| Affiliation |
Raam Clinic |
| Address |
Room No 1, Department of General Medicine,
Division of Research and Development,
No 128, Shakthy Flats, NTR Garden Street,
Flats 01 and 02, Ground Floor,
Rangarajapuram Main Road, Kodambakkam
TAMIL NADU
600024
India |
| Phone |
9840909155 |
| Fax |
|
| Email |
md@auroushealthcare.com |
|
|
Source of Monetary or Material Support
|
| K.-W. Pfannenschmidt GmbH
Habichthorst 34-36, 22459 Hamburg, Germany |
|
|
Primary Sponsor
|
| Name |
K.-W. Pfannenschmidt GmbH |
| Address |
Habichthorst 34-36, 22459 Hamburg, Germany |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Aurous HealthCare Research and Development India Pvt Ltd |
Room no 1, Department of General Medicine
Division of Research and Development
No 128, Shakthy Flats, NTR Garden Street,
Flats 01 and 02, Ground Floor,
Rangarajapuram Main Road, Kodambakkam
Chennai 600024. Tamil Nadu
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr VT Sriraam |
Raam Clinic |
Room No 1, Department of General Medicine,
Division of Research and Development
Plot No. 128, Sakthy Flats, NTR Garden Street,
Flats 01&02, Ground Floor, Rangarajapuram Main Road,
Kodambakkam,
Chennai
TAMIL NADU |
9840909155
md@auroushealthcare.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Universal Ethics Committee (A Unit of Aurous HealtCare Research and Development India Pvt. Ltd ) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Euglycemic healthy volunteers |
| Patients |
(1) ICD-10 Condition: R730||Abnormal glucose, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Glucophil - Treatment Arm I - Euglycemic |
Dose - 2 g per intake.
Dosage - 2 g to be dissolved in 200 mL of lukewarm water, mixed well and consumed 10 minutes before high carbohydrate meal.
Treatment Duration - Not applicable. Single consumption of the product is tested for three consecutive days.
Route of Administration - Oral |
| Intervention |
Glucophil - Treatment Arm II - Prediabetics |
Dose - 2 g per intake.
Dosage - 2 g to be dissolved in 200 mL of lukewarm water, mixed well and consumed 10 minutes before high carbohydrate meal.
Treatment Duration - Not applicable. Single consumption of the product is tested for three consecutive days.
Route of Administration - Oral |
| Comparator Agent |
NIL |
Not applicable. Comparison is between euglycemic and prediabetics. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Treatment Arm I
1. Clinically healthy volunteers aged between 18 and 75 years (all genders)
2. Subjects with HbA1C less than 5.7 per cent at the time of screening
Treatment Arm II
1. Prediabetic adults aged between 18 and 75 years (all genders).
2. Subjects with HbA1C between 5.7 per cent & 6.4 per cent at the time of screening
3. Naive subjects or subjects who have not consumed any medicine or product or supplement intended towards management of glucose levels, carbohydrate metabolism for 30 days prior to screening and willing to abstain during the study period.
Both Treatment Arms
1. Subjects who are not currently on a specialized diet not limited to low carb high protein, keto, paleo etc. and have not attempted such a diet for 30 days prior to screening.
2. Subjects who have not started any specified physical activity not limited to yoga, Pilates, aerobic, strength training or 10 K steps per day regimen, upto 30 days prior to screening.
3. Subjects who are not any medicine or product or supplement intended towards weight management, weight loss etc.
4. Subjects who are willing to give informed consent for participation, able to comprehend and understand the responsibilities during screening and treatment period.
5. Subjects who are willing not to participate in any other clinical trial during participation in the current trial. |
|
| ExclusionCriteria |
| Details |
1. Subjects who are obese. BMI greater than 30 kg per m2.
2. Subjects who have an active infection, disease or disorder that will prevent them from fully satisfying the responsibilities of the study.
3. Subjects with history of seizures, uncontrolled diabetes, hypertension or major cardiac illness like congestive heart failure etc.
4. Subjects on remission from cancer of any type less than 5 years at the time of screening.
5. Subjects who are planning a pregnancy and or currently breastfeeding.
6. Subjects who have participated in a clinical study less than 1 month before screening.
7. Any significant medical condition eg - significant psychiatric or neurological disorders, active alcohol or drug abuse etc. any medical condition that is unstable or poorly controlled or other factor - eg. planned relocation that the Investigator felt would interfere with study evaluations and study participation.
8. Subjects who are mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
9. Subjects who in the opinion of the Investigator are not eligible for enrolment in the study. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1. Post Prandial Glucose & Post Prandial Insulin : Dose response curves in euglycemic adults following high carbohydrate meal compared to baseline.
2. Post Prandial Glucose & Post Prandial Insulin: Dose response curves in prediabetic adults following high carbohydrate meal compared to baseline.
|
Fasting Blood Glucose
Post Prandial Glucose (30, 60, 90, 120 minutes)
Fasting Insulin
Post Prandial Insulin (60, 120 minutes)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
Target Sample Size
Modification(s)
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/03/2026 |
| Date of Study Completion (India) |
22/05/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="5" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Study Design: Open label, Prospective, Non Randomised, Comparative, Two Arm Clinical study. Indication: Carbohydrate Metabolism in Euglycemic and Pre Diabetic Adults Investigational Product: Glucophil® Comparator: Not Applicable. Not applicable. Comparison is between euglycemic and prediabetics. Dose, Dosage of Glucophil®
Dosage: 2 g to be dissolved in 200 mL of lukewarm water, mixed well and consumed 10 minutes high carbohydrate meal.
Treatment Duration: Not applicable. Single consumption of the product is tested for three consecutive days.
Route of Administration: Oral Subject Population: Adults aged between 18 and 75 years who are either euglycemic or prediabetic. Number of Subjects: 30 Evaluable Subjects Treatment Arms: Two
Treatment Arm I – 15 Subjects – Euglycemic Volunteers
Treatment Arm II – 15 Subjects – Prediabetic Volunteers Assessments (Day 1, Day3, Day 4, Day 5)
Fasting Blood Glucose
Fasting Insulin
Post Prandial Glucose (30, 60, 90, 120 Minutes)
Post Prandial Insulin (60, 120 Minutes) Background of the study: Metabolic disorders in which hyperglycaemia lasts over a longer period leading to several other complications. It is characterized by supraphysiological glucose due to the deficiency in insulin secretion or insulin receptor or post receptor events that results in the disturbances in the biochemical pathways of carbohydrates, fats and protein. Moreover, the impaired metabolism leads to the progression and aggravation of oxidative stress through different mechanisms like glucose autoxidation, protein glycation, etc. Studies direct that the incidence of diabetes will continue to rise in the future due to growing prevalence of obesity, accelerating aging populations, environmental factors and sedentary lifestyles Purpose of the Study: Type 2 Diabetes is linked to a deficiency in D- Chiro Inositol (DCI), a naturally occurring inositol that is both produced within the body and obtained through dietary sources. DCI plays a crucial role as a secondary messenger for insulin. A deficiency in DCI exacerbates insulin resistance and impairs glucose metabolism. Glucophil® is an extract of D-Pinitol derived from the fruit of the carob tree (Ceratonia siliqua). This natural ingredient comprising 97% D-Pinitol, effectively mimics insulin, promoting effective and healthy management of blood sugar levels. This clinical study aims to evaluate the efficacy and safety of Glucophil® carbohydrate metabolism parameters post high carbohydrate meal in euglycemic and prediabetic adult subjects.
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