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CTRI Number  CTRI/2013/04/003553 [Registered on: 15/04/2013] Trial Registered Retrospectively
Last Modified On: 24/06/2014
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   Clinical trial to study the Suitability for Consumption of Chyawanprakash in Controlled Type II Diabetic Patients. 
Scientific Title of Study   An Open Labeled, Multicenter, Prospective, Clinical Study to Evaluate the Suitability for Consumption of Chyawanprakash in Controlled Type II Diabetic Patients. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
CP/DM/01/2012, Final Version 3.0, 17th December 2012  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vaishali Shailesh Deshpande  
Designation  Lecturer Department of Kayachikitsa 
Affiliation  Maharashtra Aarogya Mandal’s Sumatibhai Shah Ayurved Mahavidyalaya  
Address  Department of Kayachikitsa Maharashtra Aarogya Mandal’s Sumatibhai Shah Ayurved Mahavidyalaya Malwadi Hadapsar Pune

Pune
MAHARASHTRA
411028
India 
Phone  9096082950  
Fax    
Email  dr.vaishalid@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjay Tamoli 
Designation  Director 
Affiliation  Target Institute of Medical Education and Research 
Address  Target Institute of Medical Education and Research 205 B Wing Blue Diamond Society Nayagoan Dahisar West Mumbai

Mumbai (Suburban)
MAHARASHTRA
400068
India 
Phone  02228913701  
Fax    
Email  targetinstitute@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Bhavana Zalavadiya 
Designation  Clinical Trial Manager 
Affiliation  Target Institute of Medical Education and Research 
Address  Target Institute of Medical Education and Research 205 B Wing Blue Diamond Society Nayagoan Dahisar West Mumbai

Mumbai (Suburban)
MAHARASHTRA
400068
India 
Phone  8080931975  
Fax    
Email  targetinst1@gmail.com  
 
Source of Monetary or Material Support  
Dabur Research & Development Centre (DRDC) Plot No. 22, Site-IV, Sahibabad-201 010 Ghaziabad, (UP), India  
 
Primary Sponsor  
Name  Dabur Research Development Centre DRDC 
Address  Plot No. 22, Site-IV, Sahibabad-201 010 Ghaziabad, (UP), India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abhay Kulkarni  Ayurved Research Department, Ayurved Seva Sanghs Ayurved Mahavidyalaya  Ganeshwadi Panchavati Nashik 03
Nashik
MAHARASHTRA 		 9822537240

abhaynk@yahoo.com 
Dr Vaishali Shailesh Deshpande   Department of Kayachikitsa, Maharashtra Aarogya Mandal’s Sumatibhai Shah Ayurved Mahavidyalaya  Malwadi Hadapsar Pune 28
Pune
MAHARASHTRA 		 9096082950

dr.vaishalid@gmail.com 
Dr Raman Ghungralekar  Department of Kayachikitsa, R. A. Podar Medical (Ayu) College and M. A. Podar Hospital,  Dr Annie Besant Road Worli Mumbai 18
Mumbai
MAHARASHTRA 		 9221100630

ghungaralekar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee, Maharashtra Aarogya Mandal’s Sumatibhai Shah Ayurved Mahavidyalaya, Malwadi , Hadapsar, Pune-28  Approved 
Institutional Ethics Committee, R. A. Podar Medical (Ayu) College and M. A. Podar Hospital, Dr. Annie Besant Road, Worli, Mumbai-18  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Type 2 Diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Chyawanprakash   Bilva, Agnimanth, Shyonaka, Patala, Gambhari, Shalparni, Prishnaparni, Brihati, Kantakari, Gokshur, Mudgaparni, Mashaparni, Karkatshringi, Tamalaki, Draksha, Pushkara, Haritaki, Guruchi, Karchura, Musta, Punarnava, Utpala, Vasa, Kaknashika, Yasthi, Jiwanti, Bala, Ashvagandha, Shatavari, Varahi, Kshir Vidari, Asana, Amalaki, Ghrit, Til tail, Vamsha, Pippali, Sukshmaila, Tejpatra, Nagakesara, Lavang, Tvak, and excipients. Dosage and Treatment Duration: One teaspoonful twice a day orally after meals for 90 days.  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Subjects suffering from Type II Diabetes Mellitus for more than one year, and stabilized on either exercise/diet regimen or mono / polydrug oral anti-diabetic therapy.
2.Subjects having HbA1c value below 8% at screening.
3.Subjects having Fasting Plasma Glucose 90 -150 mg/dl (both inclusive) and postprandial glucose in the range of 110-180 mg/dl at screening.
4.Subjects of female gender or non-pregnant, non-lactating females, at least six weeks postpartum. A urine pregnancy test is required for all female subjects of childbearing potential unless subject has had a hysterectomy, tubal ligation, or is > 2 years postmenopausal.
5.Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
 
 
ExclusionCriteria 
Details  1.Subjects on Insulin therapy.
2.Subjects suffering from Type I DM or type of Diabetes mellitus other than Type II.
3.Subjects having known hepatic or renal disease.
4.Subjects having an active malignancy.
5.Subjects giving history of significant cardiovascular event < 12 weeks prior to randomization.
6.Subjects having known major complications of Diabetes like Ketoacidosis, Nephropathy, Neuropathy, Retinopathy, and Diabetic wounds.
7.Subjects having a chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
8.Subjects having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes.
9.Subjects using any other investigational drug within 1 month prior to recruitment
10.Known hypersensitivity to any of the ingredients used in study drug
11.Pregnant and Lactating females.
12.Subjects participating in another Clinical trial
13.Any other condition due to which patients are deemed to be unsuitable by the investigator for reason(s) not specifically started in the exclusion criteria.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Assessment of pre and post treatment changes in HbA1c % (Glycosylated Hemoglobin %) values.

2.Post-treatment Physician global assessment of overall safety of Dabur Chyawanprakash
 		 3 month 
 
Secondary Outcome  
Outcome  TimePoints 
1.Monthly assessment of changes in fasting & postprandial plasma glucose levels
2.Assessment of Adverse Drug Reaction
3.Monthly assessment of clinically significant abnormal laboratory parameters
4.Assessment of clinical symptoms of Diabetes
5.Assessment of changes in pre and post treatment of serum insulin (fasting state) levels
6.Monthly assessment of changes in micro-albuminurea
7.Monthly assessment of changes in dose of OHAs
8.Monthly assessment of Quality of Life (On WHO Scale)
 		 0, 1, 2, 3 months 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   08/04/2013 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This study is an open labeled, multicenter, prospective, clinical study to evaluate the suitability for consumption of Chyawanprakash in controlled Type II Diabetic Patients that will be conducted in three centers in India. The drug Chyawanprakash will be given in a dose of 1 teaspoonful twice a day orally after meals for 90 days. The primary outcome measures will be assessment of pre and post treatment changes in HbA1c %   (Glycosylated Hemoglobin %) values and post-treatment physician global assessment of overall safety. The secondary outcomes will be monthly assessment of changes in fasting & postprandial plasma glucose levels, assessment of adverse drug reaction, assessment of post-treatment clinically significant abnormal laboratory parameters, assessment of clinical symptoms of diabetes, assessment of changes in pre and post treatment of serum insulin (fasting state) levels, monthly assessment of changes in micro-albuminurea,  assessment of changes in dose of OHAs and assessment of Quality of Life (On WHO Scale)  
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