CTRI

FULL DETAILS (Read-only) -> Click Here to Create PDF for Current Dataset of Trial

CTRI Number

CTRI/2025/11/098218 [Registered on: 28/11/2025] Trial Registered Prospectively

Last Modified On:

27/11/2025

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Ayurveda

Study Design

Randomized, Parallel Group, Placebo Controlled Trial

Public Title of Study

Role of Ayurveda Medicine in treatment of Diabetes

Scientific Title of Study

A Prospective, Randomised, Placebo - controlled, Double blind trial to Evaluate The Safety and Efficacy of a Proprietary Ayurveda Supplement Glucose & Metabolic Support in The Management Of Type 2 Diabetes Mellitus And Pre-Diabetes

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NOT APPLICABLE	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Keertan M S
Designation	Professor
Affiliation	KAHERs Shri B M Kanakanwadi Ayurveda Mahavidyalaya
Address	OPD No 03 and IPD Department of Roga Nidana KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Sahahapur Belagavi Belgaum KARNATAKA 590003 India
Phone	9886238888
Fax
Email	keertanms.kaher@kleayurworld.edu.in

Details of Contact Person
Scientific Query

Name	Dr Keertan M S
Designation	Professor
Affiliation	KAHERs Shri B M Kanakanwadi Ayurveda Mahavidyalaya
Address	OPD No 03 and IPD Department of Roga Nidana KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Sahahapur Belagavi KARNATAKA 590003 India
Phone	9886238888
Fax
Email	keertanms.kaher@kleayurworld.edu.in

Details of Contact Person
Public Query

Name	Dr Keertan M S
Designation	Professor
Affiliation	KAHERs Shri B M Kanakanwadi Ayurveda Mahavidyalaya
Address	OPD No 03 and IPD Department of Roga Nidana KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Sahahapur Belagavi KARNATAKA 590003 India
Phone	9886238888
Fax
Email	keertanms.kaher@kleayurworld.edu.in

Source of Monetary or Material Support

KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya Shahapur Belagavi - 590003

Primary Sponsor

Name	LYBL Healthcare Technology India Private Limited
Address	Floor No.: 5th floor Building No./Flat No.: Plot no B-9 Name Of Premises/Building: ITL Twin Tower Road/Street: Shakurbasti Rs City/Town/Village: New Delhi District: North West Delhi State: Delhi PIN Code: 110034
Type of Sponsor	Pharmaceutical industry-Indian

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 Keerthan M S	KLE Ayurveda Hospital and Medical Research Centre	OPD No 03 and IPD Department of Roganidana KLE Ayurveda Hospital and Medical Research Centre Shahapur Belagavi - 590003 Belgaum KARNATAKA	9886238888 keertanms.kaher@kleayurworld.edu.in

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee for Resaerch on Human Subjects KAHERs Shri B M Kankanawadi Ayurveda Mahavidyalaya & KLE Ayurveda Hospital Shahapur Belagavi	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition:E119\|\|Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH,

Intervention / Comparator Agent

sno	Intervention/Comparator	Type	Drug-Type	Procedure Name	Details
1	Intervention Arm	Drug	Other than Classical		(1) Medicine Name: Proprietary Ayurveda Supplement, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: Group A: 30 Diabetes Mellitus type 2 subjects with Oral Hypoglycemic Agent, Metformin 500 mg twice a day before meals and Placebo identical with Investigational product 1 tab three times a day after meals with warm water along with standard diet, lifestyle and yoga protocol.
2	Comparator Arm	Drug	Other than Classical		(1) Medicine Name: Oral Hypoglycemic Agent Metformin , Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: Group B: 30 Diabetes Mellitus type 2 subjects with Oral Hypoglycemic Agent Metformin 500 mg twice a day before meals and Glucose and Metabolic support three times a day after meals with warm water along with standard diet, lifestyle and yoga protocol.
3	Comparator Arm (Non Ayurveda)		-	Glucose and Metabolic support	Group C: 30 Pre - Diabetes Mellitus type 2 subjects: Glucose and Metabolic support 1 tab twice a day after the meals with warm water with standard diet, lifestyle and yoga protocol.

Inclusion Criteria

Age From	20.00 Year(s)
Age To	75.00 Year(s)
Gender	Both
Details	Diabetic Participants (Groups A & B): Newly diagnosed type 2 diabetes mellitus Diagnosed within 3 months of time HbA1c more than 6.5% and less than 9% Prediabetic Participants (Group C): Known pre-diabetics for more than 1 year HbA1c between 5.7% and 6.5% No systemic comorbidities like cardiovascular disease, renal impairment, or hepatic dysfunction. No evidence of significant complications of diabetes (e.g., retinopathy, nephropathy, neuropathy)

ExclusionCriteria

Details

Previously diagnosed Type 1 or Type 2 DM on insulin treatment
Secondary diabetes due to other conditions (e.g., pregnancy, Cushing’s syndrome, pancreatitis)
Pregnant and lactating mother
History of gestational diabetes
Concurrent use of other Ayurvedic or herbal medications for diabetes during past 6 months
Subjects who have completed participation in any other clinical trial during past 6 months

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Case Record Numbers

Blinding/Masking

Participant and Investigator Blinded

Primary Outcome

Outcome	TimePoints
Changes in Fasting Blood Sugar (FBS) Postprandial Blood Sugar (PPBS) HbA1c (glycated hemoglobin) Serum insulin (fasting) Urine analysis (urine glucose/ketones)	0th day and 90th Day

Secondary Outcome

Outcome	TimePoints
Clinical symptom evaluation: fatigue, polyuria, polydipsia, polyphagia WHO Quality of Life assessment: subjective improvement in daily well-being and energy levels BMI (Body Mass Index) Safety Parameters: Liver Function Test (LFT) Renal Function Test (RFT) Hemogram for general systemic assessment Monitoring of Adverse Events (AEs) throughout the study	0th day, 30th day, 60th day and 90th day

Target Sample Size

Total Sample Size="90"
Sample Size from India="90"
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)

01/01/2026

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)

Open to Recruitment

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

Group A: 30 Diabetes Mellitus type 2 subjects with Oral Hypoglycemic Agent, Metformin 500 mg twice a day before meals and Placebo identical with Investigational product 1 tab three times a day after meals with warm water along with standard diet, lifestyle and yoga protocol.

Group B: 30 Diabetes Mellitus type 2 subjects with Oral Hypoglycemic Agent Metformin 500 mg twice a day before meals and Glucose and Metabolic support three times a day after meals with warm water along with standard diet, lifestyle and yoga protocol.

Group C: 30 Pre - Diabetes Mellitus type 2 subjects: Glucose and Metabolic support 1 tab twice a day after the meals with warm water with standard diet, lifestyle and yoga protocol.