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CTRI Number  CTRI/2015/04/005719 [Registered on: 24/04/2015] Trial Registered Retrospectively
Last Modified On: 24/04/2015
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical Study of the effect of Vidangadi Ghanavati in Prameha (Diabetes Mellitus Type II). 
Scientific Title of Study   Open labelled, active controlled, randomized evaluation of the effect of Vidangadi Ghanavati in Prameha vis a vis Diabetes Mellitus (Type II). 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
nil   NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shailesh Vinayak Deshpande 
Designation  Lecturer 
Affiliation  PDEAs College of Ayurved and Research Centre 
Address  Sector 25, Pradhikaran, Nigadi, Pune 411044
Sector 25, Pradhikaran, Nigadi, Pune 411044
Pune
MAHARASHTRA
411044
India 
Phone  9763104451  
Fax    
Email  dr.shaileshd@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shailesh Vinayak Deshpande 
Designation  Lecturer 
Affiliation  PDEAs College of Ayurved and Research Centre 
Address  Sector 25, Pradhikaran, Nigadi, Pune 411044
Sector 25, Pradhikaran, Nigadi, Pune 411044
Pune
MAHARASHTRA
411044
India 
Phone  9763104451  
Fax    
Email  dr.shaileshd@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrKrutika Jadhav 
Designation  PG Student and Co-Inestigator 
Affiliation  PDEAs College of Ayurved and Research Centre 
Address  Sector 25, Pradhikaran, Nigadi, Pune 411044
Sector 25, Pradhikaran, Nigadi, Pune 411044
Pune
MAHARASHTRA
411044
India 
Phone  9967910927  
Fax    
Email  dr.krutikajadhav@gmail.com  
 
Source of Monetary or Material Support  
Nil 
 
Primary Sponsor  
Name  PDEAs College of ayurved and research centre nigdi pune 
Address  College of Ayurved and Research Centre, Sector 25, Pradhikaran, Nigadi, Pune 411044 
Type of Sponsor  Private medical college 
 
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 Shailesh Vinayak Deshpande  Department of Kayachikitsa, opd no 117  Opd no.117,Kayachikitsa department, PDEAs Ayurved Rugnalaya and Sterling Multispeciality Hospital, Sector 27, Near Bhel Chowk, Nigadi, Pradhikaran, Pune 411044
Pune
MAHARASHTRA 
9763104451

dr.shaileshd@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethics committee ,PDEA college of ayurved and research centre, pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Known cases of Diabetes mellitus type II or newly diagnosed cases of Diabetes mellitus type II,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Metformin  Metformin is a known oral hypoglycemic agent of the biguanide class which controls the blood sugar levels.It will be given in a dose of 500mg BD for a period of 90 days.  
Intervention  Vidangadi ghana vati   Vidangadi ghana vati contains Vidang(Embelia ribes Burm.f.), Shala (Shorea robusta Gaertn), Arjun (Terminalia arjuna(Roxb.) W. & A), Katphala (Myria esculeuta Buch-Ham), Kadamba Anthocephalus indicus Miq., Lodhra(Symplocos racemosa Roxb.),Asana(Pterocarpus marsupium Roxb.)and Kutaj (Holarrhena antidysenterica(Linn.) Wall.)[is a combination of ayurvedic herbs mentioned in classical text and which is effective in Prameha (diabetes mellitus typeII).It will be given in a dose of 500mg TDS for a period of 90 days. 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Either a known diabetic on treatment or a newly diagnosed diabetic.
2.Patients presenting classical symptoms of Prameha.
3.Patient with fasting blood sugar up to 250 mg% and post prandial blood sugar up to 500 mg%.
4.Patient showing good, fair and moderate control in HbA1c test.
 
 
ExclusionCriteria 
Details  1.Patients with fasting blood sugar above 250 mg% and post prandial blood sugar above 500mg%.
2.Insulin Dependent Diabetes Mellitus (IDDM) and those who are under insulin therapy.
3.Pregnant and lactating mothers.
4.Patients with acute complications like Hyperglycemic coma, Ketoacidosis, and infections like gangrene.
5.Patients with chronic complications like Nephropathy, Neuropathy and Retinopathy.
6.Patients suffering from other diseases such as Tuberculosis, Cardiac diseases, HIV.
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Assesment of symptoms and effest on BSL Fasting and Post prandial, Urine sugar and glycosylated haemoglobin HbA1c

 
90 days (3 months) 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of Lipid profile, Body weight and body mass index.  90 days (3 months) 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 2 
Date of First Enrollment (India)   26/03/2015 
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="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The syndrome Diabetes Mellitus has largely been covered under the broad heading of Prameha. It is one of the most common metabolic disorder encountered in clinical practice. A number of factors are known to be important for development of Diabetes mellitus, including obesity, excessive caloric diet, and sedentary life style. Two main types of diabetes are Type I and Type II. Now it is no more a disease related to classes but it is also affecting masses. 

         Vidangadi Ghana Vati is a classical formulation mentioned in Bhaishajya Ratnavali that consists of Vidang, Shala, Arjun, Katphala, Kadamba, Lodhra , Asana and Kutaj. Vidanga is of Kashay, Katu rasa and ushna having Ushnaveerya. Shalvruksha has kashayras, rukshaguna and is known pramehaghna. Arjun possesses kashay rasa and is laghuruksha. Katphal is of kashay, tikta, katu rasa and ushna virya having laghuruksha guna. Kadamb which is of madhur, kashayras and Lodhra is kashay and laghu ruksha. Asana which is of Kashay, tikta rasa and laghu ruksha guna and known pamehaghna, and Kutaj which is of Tikta – Kashaya rasa, Laghu ruksha guna causes kaphaghna and kledaghna effects by shoshan karma. Hence this combination possesses properties of a potent medicine useful in Santarpan janya Prameha. To make it suitable and palatable in proposed study ghanavati of Vidangadi Kwatha will be used. Hence this study is designed to evaluate the effect of Vidangadi Ghanavati in Prameha vis a vis Diabetes Mellitus (type II).

 
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