| CTRI Number |
CTRI/2025/02/079930 [Registered on: 04/02/2025] Trial Registered Prospectively |
| Last Modified On: |
30/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study add on effect of Eladi vati with oral hypoglycemic agent
metformin+Glimepiride in type 2 Diabetes Mellitus in the age group 35 to 65 year. |
|
Scientific Title of Study
|
A Randomized controlled clinical trial to evaluate add on effect of Eladi vati with oral hypoglycemic agent metformin+Glimepiride in type 2 Diabetes Mellitus . |
| 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 Akshay Bhagwan Waghmare |
| Designation |
PG Scholar |
| Affiliation |
PDEAs collage of Ayurveda and research centre nigdi pune |
| Address |
3 rd floor, kayachikitsa department,PDEAs college of Ayurveda and research centre, Nigdi pradhikaran pune
Maharashtra 411044
India
Pune
MAHARASHTRA
411044
India |
| Phone |
9552191990 |
| Fax |
|
| Email |
akshaywaghmare230@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abhishek Girish Taksale |
| Designation |
Associate professor |
| Affiliation |
PDEAs college of Ayurved and research centre nigdi pradhikaran pune |
| Address |
PDEAs college of Ayurved and research centre third floor kayachikitsa department nigdi pradhikaran pune 411044
Maharashtra India
Pune
MAHARASHTRA
411044
India |
| Phone |
9011061293 |
| Fax |
|
| Email |
taksaleabhishek@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhishek Girish Taksale |
| Designation |
Associate professor |
| Affiliation |
PDEAs college of Ayurved and research centre nigdi pradhikaran pune |
| Address |
PDEAs college of Ayurved and research centre third floor kayachikitsa department nigdi pradhikaran pune 411044
Maharashtra India
Pune
MAHARASHTRA
411044
India |
| Phone |
9011061293 |
| Fax |
|
| Email |
taksaleabhishek@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs college of Ayurved and research centre, nigdi pradhikaran, pune maharshtra india,411044 |
|
|
Primary Sponsor
|
| Name |
PDEAs college of Ayurved and research centre nigdi pradhikaran pune |
| Address |
PDEAs college of Ayurved and research centre nigdi pradhikaran pune 411044 |
| Type of Sponsor |
Private medical college |
|
|
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 Akshay Bhagwan Waghmare |
Ayurved Rugnalaya and Sterling Multispeciality Hospital Nigdi pradhikaran pune |
Ayurved Rugnalaya and Sterling Multispeciality Hospital sector 27 kayachikitsa department OPD no 117 nigdi pradhikaran pune 411044 Maharashtra
Pune
MAHARASHTRA |
9552191990
akshaywaghmare230@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 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: PRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Eladi vati , Reference: Harit Samhita , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Tandulodak ), Additional Information: To Evaluate add on effect of Eladi vati with oral hypoglycemic agent Metformin and Glimepiride in type 2 diabetes mellitus taken.
Drug: Metformin and Glimepiride Reference: Harrisons internal medicine
Dose:As prescribed by physician
Duration:90 days
Route:oral with water. | | 2 | Comparator Arm (Non Ayurveda) | | - | Metformin and Glimepiride | Drug: Metformin and Glimepiride
Reference: Harrisons internal medicine
Dose:As prescribed by physician
Duration:90 days
Route: oral with water.
|
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Two or more symptoms of Prameha Daurbalya, Kshudhavridhdhi,
Pipasatrivridhdhi, Prabhutamutrata, Naktamutrata, HastaPadatala Daha 2. Age group between 35 to 65 years.
3. Cases of both Gender will be included.
4. Known case of Type-2 DM, Non insulin dependent diabetes mellitus.
5. Patient having HbA1C upto10.
6. Patient with fasting blood sugar up to 250 mg/dl and post prandial
blood sugar up to 350 mg/dl
7. Patient taking Metformin+ Glimepiride drug since minimum 6 Months |
|
| ExclusionCriteria |
| Details |
1.Known case of Insulin Dependent Diabetes Mellitus (IDDM) and
those who are under insulin therapy.
2.Known case of Renal Disorders like Chronic kidney disease and
Acute kidney diseases.
3.Known case of acute complications Hyperglycemic &
hypoglycemic coma, Ketoacidosis and related complication and
Infections like gangrene.
4.Known case of chronic diabetic complications Nephropathy,
Neuropathy and Retinopathy.
5. Patients suffering from all major systemic disorders AIDS , TB.
6. Diabetes Mellitus developed due to secondary cause such as
infective pancreatitis, drug induced auto immune antibodies.
7. Pregnant & lactating women.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the add on effect of Eladi Vati with oral hypoglycemic agent
(Metformin + Glimepiride) in Type ll DM for 3 months.
|
90 days with follow up on
30th, 60th and 90th day.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To observe adverse effects if any.
|
90 days with follow up on
30th, 60th & 90th day. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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
|
N/A |
|
Date of First Enrollment (India)
|
15/02/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Nowadays due to the Sedentary life style, Stress and irregular dietary habits the ratio of Prameha is increasing day by day in society and the availability of patients is more. Since Eladi Vati possesses all properties of potent medicine useful for Prameha Chikitsa. To evaluate add on effect of Eladi Vati in Prameha with Oral Hypoglycemic Agent this study designed. All contains of trial drug has properties like Kledaghna, Medodushutighna, Rasayana, Kaphghna, Medodhatwagni Vardhan properties. Eladi Vati is mentioned in Harit Samhita having all the properties may revert the pathogenesis of Prameha. All the ingredients present Eladi Vati are easily available. Therefore, this formulation was chosen for present study. |