| CTRI Number |
CTRI/2025/10/096063 [Registered on: 14/10/2025] Trial Registered Prospectively |
| Last Modified On: |
13/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy and Safety Study of DyberineTM in Adult Subjects with Type 2 Diabetes Mellitus |
|
Scientific Title of Study
|
An Open-labelled, Single Arm, Interventional Pilot Study to Evaluate the Efficacy and Safety of DyberineTM in Adult Subjects with Type 2 Diabetes Mellitus |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BL/DHB/003 Version 1.0 dated 19 September, 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Giri Raja KV |
| Designation |
Consultant General Physician |
| Affiliation |
Rajalakshmi Hospital and Research Center |
| Address |
Dept of General Medicine
Rooms No 1 Ground Floor
Lakshmipura Main Road Vidyaranyapura Post
Bangalore
KARNATAKA
560097
India |
| Phone |
08023254855 |
| Fax |
08023254855 |
| Email |
drgirirajkv@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Amal Maji |
| Designation |
Scientist |
| Affiliation |
BIORADIAN LIFESCIENCE |
| Address |
Dept of Formulation and Product Development, Room No 2A, Second Floor, Sonamui Market Place, Goura, Medinipur
Medinipur
WEST BENGAL
721146
India |
| Phone |
08697612674 |
| Fax |
|
| Email |
amal.bioradian@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Manik Chaudhuri |
| Designation |
Project Manager |
| Affiliation |
BIORADIAN LIFESCIENCE |
| Address |
Dept of Projects - Clinical Trial, Room No 7, 7/1 AGB Layout 5th Cross, 1st Main Nandini Layout
Bangalore
KARNATAKA
560096
India |
| Phone |
9738651205 |
| Fax |
|
| Email |
mc.bioradian@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
M R HEALTHCARE PVT LTD |
| Address |
Tanda Mallu Kashipur Road Ramnagar Nanital
Uttarakhand
India 244715 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Giri Raja KV |
Rajalakshmi Hospital and Research Center |
Dept of General Medicine,
Rooms No 1, Ground Floor,
Lakshmipura Main Road Vidyaranyapura Post
Bangalore 560097
Bangalore
KARNATAKA |
08023254855
drgirirajkv@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rajalakshmi Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dyberine Powder |
DyberineTM Powder 200 mg twice a day for 60 days |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either sex between the age group 18 to 65 years;
Patients who are diagnosed with Type 2 Diabetes mellitus;
Patients with HbA1c euals to 7 percent or more;
Subjects with BMI more than 27 and less than 45;
Women of childbearing potential must be willing to use double-barrier contraception for the entire study;
Patients ready to abide by trial procedures and to give informed consent |
|
| ExclusionCriteria |
| Details |
Subjects with Type 1 diabetes mellitus, severe hyperglycemia FBS more than 240 or PPBS more than 360, fasting serum cholesterol more than 260 and serum Triglycerides more than 300;
Subjects with BMI more than 45, and HbA1c more than 10.5;
Subjects with severe renal, hepatic or respiratory disorder;
Subjects with psychiatric, and hematological disorders;
History of smoking more than 10 cigarettes per day or alcohol intake more than 30 ml per day;
Subjects with Ischemic heart disease with any cardiac event in last 6 months;
Participants who have participated in any investigational study in the last 4 weeks;
Patients having known hypersensitivity to the study drugs;
Patients with a history of intake of any Ayurveda, herbal, homeopathic, dietary supplements or any alternative therapies in the last one month;
Pregnant or lactating females and women in child bearing age refusing to use of contraceptive methods |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in HbA1c from screening to end of study (Day 60) |
screening to Day 60 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in fasting blood sugar (FBS); postprandial blood sugar (PPBS); body weight; BMI; waist circumference; Complete Blood Count (CBC); Liver Function Test (SGOT); Renal Function Test (Creatinine); Total Cholesterol and Triglycerides;
clinical symptom scores; Incidence and severity of adverse events |
Day 60 |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
27/10/2025 |
| Date of Study Completion (India) |
07/01/2026 |
| 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)
|
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
|
This open-labelled, single-arm interventional clinical study aims to evaluate the efficacy and safety of Dyberine powder (200 mg twice daily) in 20 adult subjects with Type 2 Diabetes Mellitus over a 60-day treatment period. The primary objective is to determine the effect of Dyberine on glycemic control, assessed by changes in HbA1c levels. Secondary objectives include evaluating changes in fasting and postprandial blood sugar, body weight, BMI, waist circumference, clinical symptoms, and laboratory safety parameters, as well as monitoring adverse events. Eligible participants are 18 to 65 years old, diagnosed with Type 2 diabetes and having HbA1c more than or equals to 7.0 and BMI 27 to 45. Individuals with Type 1 diabetes, uncontrolled metabolic values, major systemic illnesses, or recent use of alternative therapies or other investigational drugs are excluded. Assessments are conducted across four site visits: Screening, Baseline, Follow-up at Day 30, and End of Study at Day 60. Key evaluations include vital signs, anthropometric measurements, blood glucose monitoring, HbA1c, laboratory tests, and adverse event reporting. |