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CTRI Number  CTRI/2019/01/017351 [Registered on: 31/01/2019] Trial Registered Prospectively
Last Modified On: 30/11/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Diagnostic
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical trials of Kushtadi Churna Vati in Diabetes.  
Scientific Title of Study   Randomized controlled trial of Kushtadi Churna Vati as an add-on effect in the management of Madhumeha 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Yogesh T Kotangale 
Designation  Associate Professor 
Affiliation  MAM Sumatibhai Shah Ayurved mahavidyalaya Hadapsar Pune 
Address  MAMs Sumatibhai Shah Ayurved College O.P.D. No. 2 Kayachikitsa Malwadi Hadapsar Pune MAHARASHTRA 411028 India

Pune
MAHARASHTRA
411028
India 
Phone  09423218193  
Fax    
Email  drytk@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Yogesh T Kotangale 
Designation  Associate Professor 
Affiliation  MAM Sumatibhai Shah Ayurved mahavidyalaya Hadapsar Pune 
Address  MAMs Sumatibhai Shah Ayurved College O.P.D. No. 2 Kayachikitsa Malwadi Hadapsar Pune MAHARASHTRA 411028 India

Pune
MAHARASHTRA
411028
India 
Phone  09423218193  
Fax    
Email  drytk@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Shweta Lomeshwar Lade 
Designation  PG Scholar 
Affiliation  MAM Sumatibhai Shah Ayurved mahavidyalaya Hadapsar Pune 
Address  MAMs Sumatibhai Shah Ayurved College OPD No2 Kayachikitsa Malwadi Hadapsar Pune MAHARASHTRA 411028 India

Pune
MAHARASHTRA
411028
India 
Phone  9822214221  
Fax    
Email  ladeshweta1992@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  The Principal MAMs Sumatibhai Shah Ayurved College 
Address  MAMs Sumatibhai Shah Ayurved College O.P.D. NO. 2 Kayachikitsa Department Malwadi Hadapsar Pune 
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 Shweta Lade  Sumatibhai Shah Ayurved College, Sanegurujin Arogya Kendra  O.P.D. NO. 2 Kayachikitsa Department First Floor Saneguruji Arogya Kendra, Malwadi, Hadapsar, Pune-411028 Pune MAHARASHTRA
Pune
MAHARASHTRA 		 9822214221

ladeshweta1992@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board of Research  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  continue OHA  continue conventional anti diabetic drugs in prescribed dosage 
Intervention  Kushtadi churna Vati  500 mg T.D.S. orally With luke warm water pragbhakt time, total duration 3 months 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. A known Diabetic on treatmenet and a newly diagnosed Diabetes.
2. Patient with fasting blood sugar upto 220mg% and post prandial blood sugar upto 300mg%
3.patient having HBA1C upto 10
4.Patient having fasting blood sugar in between 221 to 250 and post prandial 301 ton 350 will be included , if HBA1C is upto 10.
5. If the patient is taking ayurvedic medicine for Madhumeha , washing period for them will be 8 days. 
 
ExclusionCriteria 
Details  1. Patients with fasting blood sugar above 220 mg% and post prandial blood sugar above 300mg%.
2. Patient who is already taking Ayurvedic management for Madhumeha.
3. Diabetes Mellitus Type-I ,Acromegaly, Cushing’s syndrome and pancreatic disorder.
4. Those who are under Insulin therapy.
5. Pregnant and lactating mothers.
6. Patients with acute complications like Hyperglycemic coma, Ketoacidosis and infections like gangrene.
7. Patients with K/C/O Nephropathy, Neuropathy and Retinopathy.
8. Patients with gastrointestinal diseases, Liver diseases, tumors, conditions like cardiovascular disease, acute myocardial infarction, immune-compromised disease(HIV) 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the efficacy of Kushtadi Churna Vati in Madhumeha.  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
1)To evaluate the efficacy of Kushtadi Churna Vati in Madhumeha on the basis of subjective parameters.
2)To evaluate the efficacy of Kushtadi Churna vati in reducing the elevated Blood Sugar Levels in Madhumeha in fasting state.
3) To evaluate the efficacy of Kushtadi Churna Vati in reducing the elevated Blood Sugar Levels in Madhumeha in post prandial state.
4) To evaluate the efficacy of Kushtadi Churna Vati in achieving glycemic control in Madhumeha on the basis of HbA1C. 		 3 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   Phase 1/ Phase 2 
Date of First Enrollment (India)   01/02/2019 
Date of Study Completion (India) 30/11/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Randomized controlled trial of Kushtadi Churna Vati as an add-on effect in the management of Madhumeha. Diabetes mellitus is a long term metabolic disorder that is characterized by high blood sugar, insulin resistance and relative lack of insulin. We have developed newer medicines ,but we come across limitations of OHA, therefore there is a need for traditional need for the better management of DM. Considering all above things the study will be carried out in comparison with conventional modern treatment. Patients will be divided in two groups containing 30 each. All the drugs having Pramehaghna properties as well as having Kaphahara, vatahara, Medohara and kledashoshak properties. Thus they can be helpful in reducing the symptoms and Samprapti Vighatan of the disease. 
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