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CTRI Number  CTRI/2024/02/063389 [Registered on: 29/02/2024] Trial Registered Prospectively
Last Modified On: 15/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Diabic Care Juice in Type 2 Diabetic Patients 
Scientific Title of Study   A Randomized, Open labelled, Active-controlled, Prospective Clinical Study to Evaluate Efficacy and Safety of Diabic Care Juice in Type 2 Diabetic Patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
DIABIC/DM/RA/2023 Version 1.0, 8th September 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Neena Damle 
Designation  Assistant Professor 
Affiliation  D. Y. Patil deemed to be University School of Ayurveda 
Address  Dept of Kayachikitsa, D. Y. Patil deemed to be University School of Ayurveda, Navi Mumbai, Maharashtra
Panvel, District Raigad, Maharashtra State
Thane
MAHARASHTRA
400706
India 
Phone  9769028549  
Fax    
Email  neena.damle@dypatil.edu  
 
Details of Contact Person
Scientific Query  
Name  Vinay Pawar 
Designation  Associate Professor 
Affiliation  D. Y. Patil deemed to be University School of Ayurveda, Navi Mumbai, Maharashtra 
Address  Dept of Basic Principles, D. Y. Patil deemed to be University School of Ayurveda, Navi Mumbai, Maharashtra
Nerul, Navi Mumbai - 400 706
Thane
MAHARASHTRA
400706
India 
Phone  7506631983  
Fax    
Email  vinay.pawar@dypatil.edu  
 
Details of Contact Person
Public Query  
Name  Vedvati Bhapkar 
Designation  Assistant Professor 
Affiliation  D. Y. Patil deemed to be University School of Ayurveda, Navi Mumbai, Maharashtra 
Address  Dept of Rasashastra & Bhaishajya Kalpana, D. Y. Patil deemed to be University School of Ayurveda, Navi Mumbai, Maharashtra
Nerul, Navi Mumbai - 400 706
Thane
MAHARASHTRA
400706
India 
Phone  9594830100  
Fax    
Email  drvedvati@gmail.com  
 
Source of Monetary or Material Support  
Rajputana Agrico, Jodhpur, Rajasthan 
 
Primary Sponsor  
Name  Mr Shrawan Daga 
Address  Rajputana Agrico, Jodhpur, Rajasthan 
Type of Sponsor  Other [Mr Shrawan Daga] 
 
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 Neena Damle  D. Y. Patil deemed to be University School of Ayurveda, Navi Mumbai  OPD no. 1, D. Y. Patil Ayurvedic Hospital, Nerul east, Navi Mumbai
Thane
MAHARASHTRA 		 9769028549

neena.damle@dypatil.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, D. Y. Patil deemed to be University School of Ayurveda, Nerul, Navi Mumbai  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: PRAMEHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Diabic Care Juice, Reference: NA, Route: Oral, Dosage Form: Swaras/ Juice, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -
2Comparator Arm (Non Ayurveda)-Tab. Metformin500 – 1000 mg twice a day after meals for 90 days
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Type II DM patients 
 
ExclusionCriteria 
Details  1. Patients on insulin therapy
2. Patients suffering from Type-1 DM or Type of Diabetes mellitus other than Type-2
3. Patients with known history of major complications of Diabetes like Keto-acidosis, Nephropathy, Neuropathy, Retinopathy and Diabetic wounds
4. Patients with known history of chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C or HIV
5. Patients with known history of active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes
6. Patients with known history of chronic hepatic or renal disease
7. Patients with known history of active malignancy
8. Patients with known history of significant cardiovascular event at least 12 weeks prior to randomization.
9. Known history of hypersensitivity to ingredients used in study drug
10. Pregnant and Lactating females
11. Any other conditions which in the opinion of investigator can place the patient at risk or can have influenced the conduct of study or interpretation of results
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in HbA1C% (Glycosylated Haemoglobin) (from baseline to 90 days)
2. Monthly changes in WHO-QOL-BREF over three months of the study period
 		 Day 0, Day 90 
 
Secondary Outcome  
Outcome  TimePoints 
1. Changes in fasting and post-4prandial BSL between the groups over three months of study period (on every follow up visit)
2. Changes in HOMA-IR score between the two groups from baseline to 90 days
3. Changes in clinical symptoms of Type 2 DM on every follow up visit
4. Assessment of tolerability of study drug by assessing ADRs
3. Changes in Laboratory parameters like Liver function tests (LFT) - ALT & AST, Renal function tests (RFT) - Sr. Creatinine, BUN and Sr. Uric Acid, Lipid profile, complete blood count (CBC), ESR, Urine Examination (from baseline to 90 days) 		 baseline visit (day 0), visit 1 (day 15), visit 2 (day 30), visit 3 (day 45), visit 4 (day 60), visit 5 (day 75) and visit 6 (day 90) 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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)   11/03/2024 
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  

Patients diagnosed with Type 2 Diabetes Mellitus for not more than one year and not exposed to any OHA drugs, attending outpatient clinic of study site will be screened for eligibility criteria. On screening visit, a written informed consent will be obtained from patients for their participation in the study. Patient’s history will be recorded and his/her physical examination will be done. Then patient’s fasting and postprandial blood sugar tests will be done. If HbA1c value will be between 6.5 and 8% (both inclusive) and random blood sugar level not above 200 mg/dl, then they will be advised to undergo ECG. If the ECG does not demonstrate any signs of uncontrolled arrhythmia / acute ischemia, then patient will be advised to undergo investigations i.e., CBC, ESR, Fasting Serum Insulin, Liver function tests, Renal function tests, Lipid profile, Urine routine and microscopic examinations and HIV test. Urine pregnancy test will be advised only if the patient is female of child bearing potential. Patient’s body weight, BMI, waist circumference, hip circumference and waist/hip ratio will be measured.

If patient is taking any other medication for Diabetes Mellitus, he/she will be given a out period of 7 days (screening visit to baseline visit) during which he/she will be asked to stop them.

On baseline visit, patients will be recruited in the study if he/she will meet all the inclusion/exclusion criteria. Patients will be then randomized to one of the two study groups as per the computer-generated randomization list. Patient’s general and systemic examinations will be done. Patient’s clinical symptoms of Type 2 DM will be assessed. Patient’s quality of life will be evaluated on WHO-QOL-BREF Questionnaire. Patient’s HOMA-IR score will be calculated on following formula.

[Fasting Glucose (mg/dl) X fasting insulin /405].

Patient’s body weight, BMI, waist circumference, hip circumference, waist/hip ratio, will be measured.

On baseline visit and at every follow up visit (except last follow up visit),

Diabic Care Juice bottles will be dispensed to patients in Group A. They will be instructed to consume it in a dose of 30 ml along with 30 ml water twice daily, empty stomach in morning and thirty minutes post-dinner. Patients in the group B will be prescribed tab. Metformin 500 – 1000 mg twice a day. On visit 1 (day 15), visit 2 (day 30), visit 3 (day 45), visit 4 (day 60), visit 5 (day 75), follow up with fasting and PP BSL estimation will be done for dose adjustment of OHAs in group B and requirement of OHAs as rescue medications in group A.

Drug compliance will be assessed by the investigator on every follow up visit. Patients will be advised to follow the diet and exercise regimen during the entire study. Patients will be called for follow up visits on every 15th day till 90 days after the baseline visit. On every follow up visit, patient’s general and systemic examinations and assessment of clinical symptoms of Type 2 DM will be done. Patient’s quality of life will be evaluated on WHO-QOL-BREF Questionnaire on monthly basis. Patient’s blood sugar (Fasting and Postprandial) will be checked every 15 days. Patient’s weight, BMI, waist circumference, hip circumference, waist /hip ratio will be measured.

At the end of study, patient’s HOMA-IR score will be estimated using the formula.
 Tolerability of the study drugs will be assessed by the investigator and by patient during the study period and at the end of the study. All the patients will be closely monitored for any Adverse Events starting from baseline visit till the end of the study visit. On final follow up visit (i.e., Day 90), patient’s laboratory investigations viz. CBC, ESR, BSL (fasting & Postprandial), Fasting Serum Insulin, HbA1c%, Liver function tests, Renal function tests, Lipid profile and Urine routine & microscopic will be performed. ECG will also be done at the end of the study. After completion of 90 days of study period, all the patients will be asked to stop study medication and take advice of investigator for further treatment.   
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