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CTRI Number  CTRI/2022/11/047514 [Registered on: 22/11/2022] Trial Registered Prospectively
Last Modified On: 26/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Safety and efficacy study of ‘Shreshthadi vati’ in management of ‘Madhumeha’ with special reference to type-2 diabetes mellitus. 
Scientific Title of Study   Preclinical and clinical study to evaluate the safety and efficacy of ‘Shreshthadi vati’ in management of ‘Madhumeha’ with special reference to type-2 diabetes mellitus. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vanita Nagar 
Designation  PG Scholar 
Affiliation  National Institute Of Ayurveda Deemed To Be University Jaipur Rajasthan 
Address  Department Of Kayachikitsa National Institute Of Ayurveda Deemed To Be University Jorawar Singh Gate Amer Road Jaipur Rajasthan 302002 Jaipur Rajasthan 302002 India

Jaipur
RAJASTHAN
302002
India 
Phone  9414935407  
Fax    
Email  vanitanagar97@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR Ajay Kumar Sahu 
Designation  Associate Professor Department Of Kayachikitsa 
Affiliation  National Institute Of Ayurveda Deemed To Be University Jaipur Rajasthan 
Address  Department Of Kayachikitsa National Institute Of Ayurveda Deemed To Be University Jorawar Singh Gate Amer Road Jaipur Rajasthan 302002 Jaipur Rajasthan 302002 India

Jaipur
RAJASTHAN
302002
India 
Phone  9950708106  
Fax    
Email  drajaysahu@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vanita Nagar 
Designation  PG Scholar 
Affiliation  National Institute Of Ayurveda Deemed To Be University Jaipur Rajasthan 
Address  National Institute Of Ayurveda Deemed To Be University Jorawar Singh Gate Jaipur Rajasthan 302002 Jaipure Amer Road Rajasthan 302002 India

Jaipur
RAJASTHAN
302002
India 
Phone  9414935407  
Fax    
Email  vanitanagar97@gmail.com  
 
Source of Monetary or Material Support  
National Institute Of Ayurveda Deemed To Be University Jaipur Rajasthan 
 
Primary Sponsor  
Name  National Institute Of Ayurveda Deemed To Be University Jaipur Rajasthan 
Address  National Institute Of Ayurveda Deemed To Be University Jorawar Singh Gate Jaipur Rajasthan 302002 Jaipure Amer Road Rajasthan 302002 India 
Type of Sponsor  Research institution and hospital 
 
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 Vanita Nagar  National Institute Of Ayurveda Deemed To Be University Jaipur Rajasthan  National Institute Of Ayurveda Deemed To Be University Jorawar Singh Gate Jaipur Rajasthan 302002
Jaipur
RAJASTHAN 		 9414935407

vanitanagar97@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Of National Institute Of Ayurveda Jaipur   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 ArmDrugClassical(1) Medicine Name: shreshthadi vati, Reference: (Rastantra Saar Evam Siddhaprayoga Samgriha khand-2,, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -luke warm water), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patient ready to give consent for trial and willing to participate in the study.
2. Patient between the age group of 18-70 years.
3. Sex- male and female patient.
4. Newly diagnosed (not more than 2 years) case of Madhumeha (Type 2 diabetes mellitus).
5. Patient with FBS –in range of 126-200mg/dl
PPBS-in range of 200-300mg/dl  
 
ExclusionCriteria 
Details  1. Patient not willing to sign the consent form.
2. Patients having Type-1 Diabetes Mellitus.
3. FBS>200 mg/dl and PPBS>300 mg/dl.
4. Patients of Type-2 diabetes mellitus who are on insulin therapy and Drug induced diabetes mellitus.
5. Type-2 diabetes mellitus with complications and Madhumeha with Ashadhya upadrava.
6. Patients having any serious illness like cardiovascular diseases, renal disease, hepatic disease, malignancy, any other endocrinopathies etc.
7. Pregnant and lactating mother. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
changes in objectives parameter- F.B.S. ,P.P.B.S.from baseline value.   30 days 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in the clinical symptoms of Mahdumeha (Type 2 diabetes
mellitus) 		 30 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="33" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/12/2022 
Date of Study Completion (India) 31/05/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="4"
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   In India, prevalence of diabetes mellitus is increasing at an alarming rate. Once an individual is diagnosed with diabetes mellitus the dosage of medicine is ever increasing and ultimately insulin has to be given for glycemic control. Despite of recent progression in medical science, several challenges still exist in the management of diabetes that requires special attention to develop un-explored fields of medical knowledge. Ayurveda offers comprehensive safe and effective approaches to manage this through its effect over Dhatu-agni vikriti which is considered as basic factor in the development of Madhumeha (Diabetes Mellitus).
 Among the wide varieties of drugs mentioned in Ayurveda text books the selected drug ‘Shreshthadi Vati’ is described as a significantly effective and safe drug in Rastantra Saar Evam SiddhaPrayoga Samgriha in ‘Prameha Prakaran’ but there is no research work done on ‘Shreshthadi vati’ till now, so this study will be done to evaluate the effect and safety profile of “Shreshthadi vati” in Madumeha w.s.r.to type-2 diabetes mellitus. The contents of this drug are easily available, cost effective and drug is easy to administer in the patients. That is the basic reason to select this drug for present trial.

 Aims and objectives: - The present study has been designed with following aims and objectives. 
ï‚— 1)To validate the safety profile (oral acute toxicity) of Shreshthadi Vati in Wistar albino rats. 
 ï‚— 2)To evaluate the efficacy of Shreshthadi Vati in streptozotocin induced diabetes mellitus in Wistar albino rats. 
 ï‚— 3)To evaluate the clinical efficacy of Shreshthadi Vati in the management of Madhumeha w.s.r. to type-2 diabetes mellitus. 

Hypothesis: - 
Null hypothesis(H0): -There is no effect of trial drug ‘Shreshthadi Vati’ in management of Madhumeha with special reference to Type-2 diabetes mellitus 
 Alternative Hypothesis(H1): - There is significant effect of trial drug ‘Shreshthadi Vati’ in management of Madhumeha with special reference to Type-2 diabetes mellitus
 
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