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CTRI Number  CTRI/2017/12/010837 [Registered on: 11/12/2017] Trial Registered Prospectively
Last Modified On: 19/11/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Unhealthy diet and sedentary lifestyle as a cause in the development of Diabetes Mellitus and its treatment with some ayurvedic drugs 
Scientific Title of Study   An Epidemiological Study to identify Santarpaṇa Hetu and to assess the Quality of Life in Patients of Madhumeha (Diabetes Mellitus) and Therapeutic Trial to Evaluate the Efficacy of Nyagrodhādi Vaá¹­Ä« and Mehamudgara Vaá¹­Ä«  
Trial Acronym  ESISHAQOLMTNM 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Talekar Manisha Tatobaji 
Designation  Ph.D Scholar 
Affiliation  National Institute of Ayurveda, Jaipur 
Address  Ph.D Scholar, P.G.Department of Roganidana evam Vikriti Vijnana, National Institute of Ayurveda, Jaipur RAJASTHAN 302002 India

Jaipur
RAJASTHAN
302002
India 
Phone  8824854303  
Fax    
Email  dr.mani21jan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr B K Sevatkar 
Designation  Assistant Professor 
Affiliation  National Institute of Ayurveda, Jaipur 
Address  Assistant Professor, P.G.Department of Roganidana Evam Vikriti Vijnana, National Institute of Ayurveda, Jaipur RAJASTHAN 302002

Jaipur
RAJASTHAN
302002
India 
Phone    
Fax    
Email  drbks6@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Talekar Manisha Tatobaji 
Designation  Ph.D Scholar 
Affiliation  National Institute of Ayurveda, Jaipur 
Address  Ph.D Scholar, P.G.Department of Roganidana evam Vikriti Vijnana, National Institute of Ayurveda, Jaipur RAJASTHAN 302002 India

Jaipur
RAJASTHAN
302002
India 
Phone  8824854303  
Fax    
Email  dr.mani21jan@gmail.com  
 
Source of Monetary or Material Support  
Pharmacy Of National Institute Of Ayurveda Jorawar Singh Gate Amer Road JAIPUR 302002 Rajasthan  
 
Primary Sponsor  
Name  National Institute of Ayurveda 
Address  Jorawar singh Gate, Amer road Jaipur, 302002, Rajasthan  
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 Talekar Manisha Tatobaji  National Institute of Ayurveda, Jaipur  OPD Room No-7 & OPD Room No-17, P.G.Department of Roganidan Evam Vikriti Vijnana, Jorawar singh Gate, Amer road Jaipur, 302002, Rajasthan
Jaipur
RAJASTHAN 		 8824854303

dr.mani21jan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee National Institute of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Mehamudgara Vaá¹­Ä«  Mehamudgara Vaá¹­Ä« 1 gm /day in 2 divided doses (2 Vaá¹­Ä« BD, each Vaá¹­Ä« of 250 mg) with Luke warm water for 6 weeks. 
Comparator Agent  Nyagrodhādi Vaá¹­Ä«  Nyagrodhādi Vaá¹­Ä« 6 gm /day in 3 divided doses (4 Vaá¹­Ä« TDS, each Vaá¹­Ä« of 500mg) with Luke warm water for 6 weeks. 
 
Inclusion Criteria  
Age From  30.00 Day(s)
Age To  70.00 Day(s)
Gender  Both 
Details  Patients of type-2 diabetes fulfilling the criteria of American Diabetes Association (ADA) for Diabetes Mellitus.
Patients of age group 30 years – 70 years of either gender.
Patients who shows clinical signs and symptoms of Madhumeha (type- 2 DM).
 
 
ExclusionCriteria 
Details  Patient of IDDM (type-1 D.M.)
Complicated cases of Diabetes Mellitus.
Type-2 Diabetes patient on insulin therapy.
Patients with Gestational Diabetes Mellitus and lactating mother etc.
Patients with Fasting blood sugar more than 200 mg/dl and post prandial blood sugar more than 300 mg/dl.
Diabetic patients with severe complications like cardiovascular diseases, Nephropathy, Retinopathy, Diabetic foot etc.
Diabetes due to endocrinopathies e.g. Phaeochromocytoma, Acromegaly, Cushing’s syndrome, Hyperthyroidism etc.
Patients with genetic syndromes associated with D.M. like Down’s syndrome,Klinefelter’s syndrome, Turner’s syndrome.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Developed low cost management in Madhumeha (Diabetes) for symptomatic relief in Madhumehi (Diabetic) patients.   6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Devoloped awareness about Santarpana Hetu(Unhealthy diet and Sedentary lifestyle) in Diabetic patients.  6 weeks 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="120" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   11/12/2017 
Date of Study Completion (India) 29/03/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="5"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
A Randomised clinical trial has been designed to assess the efficacy of â€˜Nyagrodhādi Vaṭī’ and ‘Mehamudgara Vaṭī’ in the management of Madhumeha (Type-2 Diabetes Mellitus).  Total 120  patients of Madhumeha (Type-2 Diabetes Mellitus) will be selected from Diabetic O.P.D. and O.P.D. of Roganidana Evam Vikrti Vijnana department of N.I.A. and randomly divided in 2 groups having 60 patients each. Group A (60 Patients) will be received Nyagrodhādi Vaá¹­Ä« , 6 gm /day in 3 divided doses (4 Vaá¹­Ä« TDS, each Vaá¹­Ä« of 500mg) for 6 weeks. Group B (60 Patients) will be received Mehamudgara Vaá¹­Ä« , 1 gm /day in 2 divided doses (2 Vaá¹­Ä« BD, each Vaá¹­Ä« of 250mg) for 6 weeks. Patients will be reviewed on 15th, 30th and 45th day after their inclusion in trial. Assessment of effects of the therapy will be done on the basis of various subjective and objective criteria. Any change in sign and symptom will be noted. Laboratory investigation will be repeated after the completion of the trial and the result will be documented.  Data will be analyzed using appropriate statistical tests. 

 
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