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CTRI Number  CTRI/2023/04/051857 [Registered on: 21/04/2023] Trial Registered Prospectively
Last Modified On: 28/11/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A Clinical trial to study the effect of a herbal drug, D-Prio in patients with Type 2 Diabetes mellitus 
Scientific Title of Study   A Prospective, Open Label Single-Arm Clinical Study to Assess the Efficacy and Safety of D-PRIO®, a herbal formulation on patients with Type 2 Diabetes Mellitus. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
PHPL-DP-CT01-Version 01- 01.02.23  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aman Khanna 
Designation  Principal Investigator 
Affiliation  Aman Hospital & Research Center 
Address  Aman Hospital and Research Center, 15 Shashwat, Opposite E.S.I. Hospital, Gotri Road, Vadodara, India

Vadodara
GUJARAT
390021
India 
Phone  9904402122  
Fax    
Email  amankhanna1974@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Aman Khanna 
Designation  Principal Investigator 
Affiliation  Aman Hospital & Research Center 
Address  Aman Hospital and Research Center, 15 Shashwat, Opposite E.S.I. Hospital, Gotri Road, Vadodara, India

Vadodara
GUJARAT
390021
India 
Phone  9904402122  
Fax    
Email  amankhanna1974@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Aman Khanna 
Designation  Principal Investigator 
Affiliation  Aman Hospital & Research Center 
Address  Aman Hospital and Research Center, 15 Shashwat, Opposite E.S.I. Hospital, Gotri Road, Vadodara, India

Vadodara
GUJARAT
390021
India 
Phone  9904402122  
Fax    
Email  amankhanna1974@gmail.com  
 
Source of Monetary or Material Support  
Priority Herbals Pvt. Ltd., Survey No. 28A, Shri Ram Colony No.4, Balwant Nagar, Shivnagari, Pune - 411033, India 
 
Primary Sponsor  
Name  Priority Herbals Pvt Ltd 
Address  Survey No. 28A, Shri Ram Colony No.4, Balwant Nagar, Shivnagari, Pune - 411033, India 
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 Aman Khanna  Aman Hospital & Research Center  Room No.504, Clinical Research Department, Aman Hospital & Research Center, 15 Shashwat, Opp. E.S.I Hospital, Gotri Road, Vadodara-390021, India.
Vadodara
GUJARAT 		 9904402122

amankhanna1974@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Aman Hospital & Research Center Institutional Ethics Committee  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  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: D-Prio, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 475(mg), Frequency: bd, Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
(2) Medicine Name: 3 Months, Reference: NA, Route: , Dosage Form: Capsules, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
(3) Medicine Name: 3 Months, Reference: NA, Route: , Dosage Form: Capsules, Dose: (), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information:
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Adult males and females of ages ≥ 18 years and ≤60 years
2. Patients who can and willing to provide written Informed Consent.
3. Patients suffering from Type-2 Diabetes of less than 10 years duration
4. Patients with HbA1c >6.5% and <9%
5. Patients with fasting plasma glucose >126 mg/dL and <180 mg/dL
6. Patients with Body mass index: 25-34.9 kg/m2
7. Participant who agree to take Investigational product (IP) till Day 90.
8. Patients willing to be on a restricted diet (no sugary foods or drinks, no sugar in tea or coffee, no honey, no rice, no white bread, no potatoes, no fried meat/fish, no banana and mangoes) during the duration of the study
9. Patients having capability of complete compliance and completion of follow-up
10. Participant / participant’s legally acceptable representative understands and can comply with clinical trial protocol requirements.
 
 
ExclusionCriteria 
Details  1. Patients on current prescription of any medicine for Diabetes or any drug that impacts glucose level
2. Patients with diabetes other than Type 2 diabetes mellitus
3. Patients having a history or presence of clinically relevant cardiovascular renal thyroid metabolic hematological neurological psychiatric systemic or infectious disease or malignant tumor
4. Patients suffering from any Bleeding disorders or Glucose 6-Phosphate Dehydrogenase deficiency
5. Patients with severe mental disorder
6. Patients with recent hospitalization for major illness or elective surgery within 1 year of the start date of study
7. Female patients with pregnancy or lactation or intention to become pregnant and not using appropriate contraceptive methods
8. Patients with terminal illness
9. Patients with history of alcoholism or substance abuse
10. Patients who are not willing to take investigational product
11. Patients with known history of sensitivity or allergy to any herbs or herbal products
12. Patients on dietary supplements or multivitamins or disease specific oral nutrition supplements
13. Patients with uncontrolled or unstable comorbidities
14. Patients with respiratory conditions or diagnostic history with chronic lung disease or active malignancy or chronic kidney disease or chronic liver disease
15. Patients taking part in any other studies including macro or micro or any other forms of dietary supplements or multivitamins or disease specific oral nutrition supplements
16. Any other condition which the principal investigator thinks may jeopardize the safety of patients with uncontrolled or unstable comorbidities
17. Patients who had participated in other clinical trials during previous 3 months
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in mean levels of Blood Glucose (Fasting and Post Prandial) and Glycated hemoglobin (Hb1Ac)   at baseline, 90th day  
 
Secondary Outcome  
Outcome  TimePoints 
Change in Fasting and Post prandial blood glucose levels after every 15 days upto 3 months; Change in Body weight, BMI and Diastolic and Systolic at the end of every month; Change in Total cholesterol, HDL, LDL, Triglycerides, SGPT, SGOT, Bilirubin and Creatinine on Day 90 (end of treatment) as compared to baseline (before treatment levels). Mean change in QoL status will be determined before treatment and at the end of every month. Patient’s Global Assessment of Tolerability to Therapy (PGATT) score will be assessed at the end of study. Number and proportion of Treatment Emergent Adverse Events (TEAEs) will be noted during the complete trial/study duration  Every 15 days, some parameters at the end of every month, and some at the end of 3 months 
 
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   N/A 
Date of First Enrollment (India)   05/05/2023 
Date of Study Completion (India) 03/10/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This study is an Open Label, Single- Arm, Prospective, Intervention Study, single-centre trial studying the safety and efficacy of D-Prio (475 mg capsules) twice daily for 3 months in 30 patients with Type 2 diabetes mellitus that will be conducted in only one center in India. The primary outcome measures will be Change in mean levels of Blood Glucose levels (Fasting and Post Prandial) and Glycated hemoglobin (Hb1Ac) measured from baseline (before start of treatment) to the end of treatment (Day 90). The secondary outcomes will be Change in Fasting and Post prandial blood glucose levels after every 15 days upto 3 months; Change in Body weight, BMI and Diastolic and Systolic at the end of every month; Change in Total cholesterol, HDL, LDL, Triglycerides, SGPT, SGOT, Bilirubin and Creatinine on Day 90 (end of treatment) as compared to baseline (before treatment levels). Mean change in QoL status will be determined before treatment and at the end of every month. Patient’s Global Assessment of Tolerability to Therapy (PGATT) score will be assessed at the end of study. Number and proportion of Treatment Emergent Adverse Events (TEAEs) will be noted during the complete trial/study duration. 
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