| CTRI Number |
CTRI/2025/07/090572 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study on the Use of a Herbal Supplement (DiaB Max™) Along with Regular Treatment in People with Type 2 Diabetes to improve blood sugar level. |
|
Scientific Title of Study
|
Effectiveness of Advanced Supercritical Fluid Extraction based herbal drug (DiaB Max TM) as an adjunctive therapy in the management of Type 2 Diabetic Patients: A Randomized Controlled, Double-Blind Clinical 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 S N Meenakshi Sundari |
| Designation |
MBBS., MD., Professor, Department of General Medicine |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
Department of General Medicine, Ground Floor, Unit- 5 , Block-B, Room Number G-02, general medicine OPD, SRM Hospital and Research Centre, SRM Nagar, Kattankulathur.
Department of General Medicine, Ground Floor, Unit- 5 , Block-B, Room Number G-02, general medicine OPD, SRM Hospital and Research Centre, SRM Nagar, Kattankulathur.
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9444249933 |
| Fax |
|
| Email |
meenakss1@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T M Vijaya kumar |
| Designation |
M.PHARM., Ph.D., Professor and HOD of Pharmacy Practice |
| Affiliation |
SRM Institute of Science and Technology |
| Address |
J block, 01 Room, 4th floor, Department of Pharmacy practice, SRM Hospital and Research Centre, SRM nagar, Kattankulathur
J block, 01 Room, 4th floor, Department of Pharmacy practice, SRM Hospital and Research Centre, SRM nagar, Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9003400450 |
| Fax |
|
| Email |
vijaypractice@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Sriramavaratharajan |
| Designation |
Head-Clinical Research |
| Affiliation |
Purple Life Sciences Pvt. Ltd |
| Address |
Purple Life Sciences Pvt. Ltd, Brundavan colony, Plot no 2 and 3, Gandipet Main Rd, Narsingi, Gandipet, Telangana 500075
Purple Life Sciences Pvt. Ltd, Brundavan colony, Plot no 2 and 3, Gandipet Main Rd, Narsingi, Gandipet, Telangana 500075
Hyderabad
TELANGANA
500075
India |
| Phone |
919884935025 |
| Fax |
|
| Email |
clinical@purplelifesciences.com |
|
|
Source of Monetary or Material Support
|
| Purple life sciences Pvt Ltd |
|
|
Primary Sponsor
|
| Name |
Purple life sciences Pvt Ltd |
| Address |
Purple life sciences Pvt Ltd, Brundavan colony, plot 2 and 3, Gandipet, main road, Narsingi, Hyderabad, Telangana- 500075 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SRM Hospital and Research Centre |
SRM Hospital and Research Centre, Srm nagar, potheri, kattankulathur, 603203 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| E Arun |
SRM Hospital and research centre |
SRM Hospital and Research Centre, Kattankulathur
SRM nagar, kattankulathur
Kancheepuram
TAMIL NADU |
9965666156
ekarun2002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Srm Medical College Hospital and Research Centre, 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. Ayurveda Condition: Nil, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Dia B Max, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Comparator Arm (Non Ayurveda) | | - | Placebo | Placebo 500 mg OD for 90 days |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Type 2 Diabetes Mellitus patients above 18 years of age.
Patients receiving antihyperglycemic medication before randomization and HbA1c between 6.5% to 10% at randomization.
Patients willing to give informed consent.
|
|
| ExclusionCriteria |
| Details |
Type 1 Diabetes or uncontrolled T2DM with HbA1c more than 10 %.
Patients with known hypersensitivity to any herbal component.
Pregnant or lactating women.
Patients with history of severe liver or kidney disease.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| DiaB Max a SCFE-based novel herbal formulation may provide improvement in insulin sensitivity. |
DiaB Max a SCFE-based novel herbal formulation may provide improvement in insulin sensitivity. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| DiaB Max a SCFE-based novel herbal formulation may result in reduction of HbA1c, FBS, PPBS levels |
90 days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
20/07/2025 |
| 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="0"
Months="6"
Days="30" |
|
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
|
Patients will be randomized based on random allocation software into two groups. Group 1 patient will be given with DiaB Max for 3 months once daily, after food and group 2 given with placebo for 3 months. Patients will be evaluated with fasting insulin, fasting and post prandial blood sugar and glycated haemoglobin on baseline and end of the study. |