| CTRI Number |
CTRI/2024/04/065001 [Registered on: 01/04/2024] Trial Registered Prospectively |
| Last Modified On: |
04/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical Study on Diabetes supplement in participants with diabetes. |
|
Scientific Title of Study
|
Clinical study to Evaluate Efficacy and Safety of EL/DM/01 in participants with Type 2 Diabetes mellitus. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| EMIL/DM/2023, Version 1.0, 15th Nov 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shishir P Pande |
| Designation |
Associate Professor |
| Affiliation |
Ayurved Seva Sangh,Ayurved Mahavidyala, Ganeshwadi, Nashik |
| Address |
Department of Rasashastra, OPD No. 9, Ground Floor, Ayurved Seva Sangh,Ayurved Mahavidyala, Ganeshwadi, Nashik, India.
Nashik
MAHARASHTRA
422003
India |
| Phone |
9420830818 |
| Fax |
|
| Email |
shishir.nsk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd. |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd.
A wing 402 A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai.
Mumbai (Suburban)
MAHARASHTRA
400064
India |
| Phone |
09322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay Tamoli |
| Designation |
Director |
| Affiliation |
Target Institute of Medical Education and Research Pvt. Ltd. |
| Address |
Target Institute of Medical Education and Research Pvt. Ltd.
A wing 402 A/B/C, Jaswanti Allied Business Center, Ramchandra Lane Extension, Kachpada, Malad West, Mumbai.
MAHARASHTRA
400064
India |
| Phone |
09322522252 |
| Fax |
|
| Email |
targetinstitute@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Emil Pharmaceutical Industries Private Limited,
301, Western Edge 1, Above Metro Mall, Magathane, Western Express Highway, Kulupwadi, Borivali East, Mumbai, Maharashtra 400066 India.
|
|
|
Primary Sponsor
|
| Name |
Emil Pharmaceutical Industries Private Limited, |
| Address |
301, Western Edge 1, Above Metro Mall, Magathane, Western Express Highway, Kulupwadi, Borivali East, Mumbai, Maharashtra 400066 India
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shishir P Pande |
Ayurved Seva Sangh, Ayurved Mahavidyalaya, |
Department of Rasashastra Department,
OPD No. 9, Ground Floor, Ayurved Seva Sangh, Ayurved Mahavidyalaya, Ganeshwadi,
Nashik-422003, India.
Nashik
MAHARASHTRA |
9420830818
shishir.nsk@gmail.com |
| Dr Shailesh V Deshpande |
Parul Ayurveda Hospital, Parul University |
Department of Kayachikitsa,
OPD no 106, Ground Floor,
Parul Ayurveda Hospital, Parul
University, P.O. Limba,
Tal. Wagholia, Dist.
Vadodara, Gujarat, 391760
Vadodara
GUJARAT |
9763104451
dr.shaileshd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, PIAR, IECHR, Ishwarapura, Limda, Waghodia, Vadodara |
Approved |
| Institutional Ethics Committee Ayurveda Seva Sangh, Ayurveda Mahavidyalaya, Nashik |
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 |
For Both the COHORTS
Product: EL/DM/01 |
Dosage and treatment duration
2 Tablets twice daily orally after meals for 90 days
|
| Comparator Agent |
FOR BOTH THE COHORTS
Product: Placebo |
2 Tablets twice daily orally after meals for 90 days |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Cohort 1
1. Patients diagnosed with type 2 diabetes mellitus and are taking oral hypoglycemic agents on regular basis
Cohort 2
1. Patients newly diagnosed with type II diabetes mellitus (newly diagnosed cases will be considered as those who have been diagnosed for diabetes mellitus for not more than one year) and those who are not on any oral hypoglycemic agent/insulin
For Both the Cohorts:
2.Patients having HbA1C value between 6.5 to 9.5 percent (both inclusive) at screening.
3.Patients having Fasting Plasma Glucose between 126 to 250 mg per dl (both inclusive) at screening.
4.Patients having postprandial glucose not more than 350 mg per dl at screening
5.Patient’s ECG does not demonstrate any signs of uncontrolled arrhythmia, acute ischemia.
6.A negative urine pregnancy test for all female patients unless patient has had a hysterectomy, tubal ligation, or is greater 2 years post menopause.
7. Patients willing to follow the procedures as per the study protocol and voluntarily signing informed consent form.
|
|
| ExclusionCriteria |
| Details |
For Both Cohorts:
1. Patients suffering from type-1 DM or types of Diabetes mellitus other than Type-2
2. Patients taking Insulin for the management of Diabetes
3. Patients with known history of chronic hepatic or renal disease.
4. Patients with known history of malignancy.
5. Patients with known history of significant cardiovascular event 12 weeks prior to randomization.
6. Patients with known history of major complications of Diabetes like Ketoacidosis, Nephropathy, Neuropathy, Retinopathy, and Diabetic wounds.
7. Patients with known history of chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
8. Patients with known history of active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes.
9. History of Use of any other investigational product within 1 month prior to randomization
10. Known history of hypersensitivity to ingredients used in study product
11. Pregnant and Lactating females.
12. Any other conditions which in the opinion of investigator will place the Patients at risk or will influence the conduct of study or interpretation of results
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pharmacy-controlled Randomization |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in HbA1c percent (average change and proportion of subjects achieving target HbA1c levels below 6.5 percent).
2. Change in quality of life assessed on QOLID
|
Day -7, day 0, day 30, day 60 and day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in FBS and PPBS (average change and proportion of subjects achieving target Fasting blood sugar of 110 mg per dl and PP blood sugar levels of 140 mg per dl).
2. Change in Fasting Serum Insulin
3. Change in HOMA-IR score
4. Change in clinical symptoms of Type 2 DM
5. Difference in requirement of Oral Hypoglycemic agents
6. Monthly change in weight and BMI
7. Change in global assessment for overall change by subject and investigator
8. Tolerability of study products
9. Change in Laboratory parameters
|
Day -7, day 0, day 30, day 60 and day 90 |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "122"
Final Enrollment numbers achieved (India)="122" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/04/2024 |
| Date of Study Completion (India) |
24/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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)
|
It is a randomized, double blind, multi-center, placebo controlled, prospective, interventional, clinical study to evaluate efficacy and safety of EL/DM/01 in participants with Type 2 Diabetes mellitus. The study will be carried out at 5 to 6 centers in India. The study will have to cohorts. In cohort 1, 60 participants with type 2 diabetes mellitus who are taking oral hypoglycemic agents on regular basis will be completed. In cohort 2, 60 participants with newly diagnosed type II diabetes mellitus (newly diagnosed cases will be considered as those who have been diagnosed for diabetes mellitus for not more than one year) and those who are not on any oral hypoglycemic agent/insulin will be completed. For both the cohorts, subjects will be asked to consume given study product in a dose of 2 tablets twice daily orally after meals with water for 90 days. The primary objectives of the study will be to assess change in HbA1c percent (average change and proportion of subjects achieving target HbA1c levels below 6.5 percent) and change in quality of life assessed on QOLID. The secondary objectives of the study will be to assess change in FBS and PPBS (average change and proportion of subjects achieving target Fasting blood sugar of 110 mg per dl and PP blood sugar levels of 140 mg per dl), change in Fasting Serum Insulin, change in HOMA-IR score, change in clinical symptoms of Type 2 DM, difference in requirement of Oral Hypoglycemic agents, monthly change in weight and BMI, change in global assessment for overall change by subject and investigator, tolerability of study products and change in laboratory parameters on day -7, day 0, day 30, day 60 and day 90.
Results and Observations:
Cohort
1
The
study concludes that use of EL/DM/01 tablets showed significant reduction in
HbA1c and Blood sugar (PP) levels in a dose of 2 tablets twice a day for a
period of 90 days. There was a significant reduction in symptoms associated
with diabetes like polydipsia and fatigue. Also, significant improvement in quality-of-life
parameters as measured on QOLID was observed with the use of EL/DM/01. The use
of EL/DM/01 was found to be safe as observed with no significant change in
bio-chemical laboratory parameters, vitals, clinical symptoms and adverse
events. The study concludes that EL/DM/01 can be safely recommended for
Diabetes.
Cohort 2
The
study concludes that use of EL/DM/01 showed significant reduction in HbA1c and
Blood sugar (PP) levels in a dose of 2 tablets twice a day for a period of 90
days. There was a significant reduction in symptoms associated with diabetes
like polyuria, polyphagia, polydipsia and fatigue. Also, significant
improvement in quality-of-life parameters as measured on QOLID was observed
with the use of EL/DM/01. The use of EL/DM/01 was found to be safe as observed
with no significant change in bio-chemical laboratory parameters, vitals,
clinical symptoms and adverse events. The study concludes that EL/DM/01 can be
safely recommended for Diabetes |