| CTRI Number |
CTRI/2024/07/070384 [Registered on: 10/07/2024] Trial Registered Prospectively |
| Last Modified On: |
24/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of Efficacy and Safety of Diabetic Care Juice in Diabetic patients. |
|
Scientific Title of Study
|
Clinical Evaluation of Diabic Care Juice in the management of Type II Diabetes Mellitus (Madhumeha)in newly diagnosed patients. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| ARL/CT/011/24 Version 1.0 Dated 28-May-2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjay Mishra |
| Designation |
Prinicipal Investigator |
| Affiliation |
Rumedic Hospital |
| Address |
Rumedic Hospital
Rz 52-4/3 Raj Nager Part 1 Street No 9, Old Mehrauli Rd, Near Shiv Saktti Mandir, Palam, New Delhi, Delhi
South West
DELHI
110075
India |
| Phone |
08527569065 |
| Fax |
|
| Email |
sanmishra75@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manoj Karwa |
| Designation |
Head Clinical Trials and Pharmacovigilance |
| Affiliation |
Auriga Research Pvt Ltd |
| Address |
Auriga Research Pvt Ltd.,
136, Sector 5, IMT Manesar, Gurugram
Haryana 122050
Gurgaon
HARYANA
122050
India |
| Phone |
9313367656 |
| Fax |
|
| Email |
manojkarwa@aurigaresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Shrawan Daga |
| Designation |
Business Head |
| Affiliation |
Krishnas Herbal & Ayurveda |
| Address |
Krishnas Herbal & Ayurveda
Plot No.1 Heavy Industrial Area, Near New Power House Road, Jodhpur, Rajasthan 34200
Jodhpur
RAJASTHAN
34200
India |
| Phone |
08448573595 |
| Fax |
|
| Email |
shrawan@krishnaayurved.com |
|
|
Source of Monetary or Material Support
|
| Rajputana Agrico,
Plot No.1 Heavy Industrial Area, Near New Powerhouse Road, Jodhpur, Rajasthan 34200 |
|
|
Primary Sponsor
|
| Name |
Krishnas Herbal and Ayurveda |
| Address |
Plot No.1 Heavy Industrial Area, Near New Power House Road, Jodhpur, Rajasthan 34200 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Piyush Juneja |
AyuQuo Herbals |
AyuQuo Herbals,
Ground Floor, Doctor Room 1, VPF-03, 1st Floor, Krishna Vista Plaza, Indirapuram, Ghaziabad, 201014
Ghaziabad
UTTAR PRADESH |
09267920012
piyushjuneja1@gmail.com |
| Dr Sanjay Mishra |
Rumedic Hospital |
OPD 01, Ground Floor, Rz 52-4/3 Raj Nager Part 1 Street No 9, Old Mehrauli Rd, Near Shiv Saktti Mandir, Palam, New Delhi, Delhi
South West
DELHI |
8527569065
sanmishra75@gmail.com |
| Dr Preeti Chhabra |
Shri Krishna Super Speciality Institute of Ayurveda |
48A, Block C4A, Ground Floor, Janakpuri, New Delhi, Delhi, 110058
West
DELHI |
9891008498
drrajchh@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Good Society for Ethical Research |
Approved |
| Good Society for Ethical Research |
Approved |
| Good Society for Ethical Research |
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: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Diabic Care Juice, Reference: NA, Route: Oral, Dosage Form: Swaras/ Juice, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: Nil |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
I. Both Male and female patients aged between 18-70 years with BMI range of 18 to 40.
II. Newly diagnosed or recently diagnosed (last 6 months), not taking any oral antidiabetic medications.
III. Patients with HbA1c of greater than or equal to 6.5% to less than or equal to 8.9%
IV. Ready to provide written informed consent form.
V. No History of any known allergy with Diabic Care Juice like products or any other ingredients.
VI. Willing to come for follow up visits for evaluation.
VII. No significant medical/surgical disease/s at the time of screening.
|
|
| ExclusionCriteria |
| Details |
I. Presence of any clinically significant medical or surgical condition requiring long term treatment.
II. Patients who are currently using the AYUSH related medications.
III. Patients already diagnosed to be suffering from the complications of Diabetes Mellitus viz., diabetic neuropathy, diabetic nephropathy, diabetic retinopathy, etc
IV. Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, Stroke or Severe Arrhythmia in the last 3 months
V. Patients with concurrent serious Hepatic Dysfunction defined as AST and ALT more than 3 times of the upper normal limit or Renal Dysfunction defined as S. creatinine more than 1.2mg per dl, uncontrolled or other concurrent severe disease.
VI. Patients participating or participated in another clinical study within 3 months before recruitment.
VII. Pregnant or Lactating women.
VIII. Patient on steroids, oral contraceptive pills.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in Glycemic assessment (FPG and PPG) from Baseline to Week 4, Week 8 and Week 12.
2. Change in Glycated hemoglobin (HbA1c) from Baseline to Week 12.
|
Baseline Day 0, Visit 2 Week 4, Visit 3 Week 8 and Visit 4 Week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess change in Symptoms Diabetes Symptoms Questionnaire (DSQ)
2. To assess change in Lipid profile, Liver function & Renal function test values from baseline to 12th week.
3. Safety outcomes during entire observation period 3 months (Incidence of adverse events)
4. To evaluate the frequency of patients transitioning from Diabic Juice to alternative antidiabetic therapies.
5. Adverse events Data for any Adverse Event reported will be collected & recorded.
|
Baseline Day 0, Visit 2 Week 4, Visit 3 Week 8 & Visit 4 Week 12 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
17/07/2024 |
| Date of Study Completion (India) |
10/03/2025 |
| 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
|
This single-arm, multicenter study aims to assess the efficacy and safety of Diabetic Care Juice in 30 male and female diabetic patients aged 18-70 years, newly diagnosed within the last six months and not on any oral antidiabetic medications. The study involves four site visits: Day 0 (Screening & Baseline), Week 4, Week 8, and Week 12. Patients will consume 30 ml of Diabetic Care Juice twice daily for three months. Fasting blood glucose and postprandial glucose will be measured at all four visits, while HbA1c, lipid profile, liver function, and renal function tests will be conducted at the screening and end-of-study visits. |