FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/10/028201 [Registered on: 01/10/2020] Trial Registered Prospectively
Last Modified On: 30/09/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effect of novel ayurvedic choorna in patients with Type 2 Diabetes mellitus 
Scientific Title of Study   An open labelled randomized controlled clinical study to evaluate the anti-hyperglycemic activity of novel ayurvedic choorna in the management of prameha vis-a-vis type2 diabetes mellitus 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prasanna Narasimha Rao 
Designation  Principal 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan 
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan Karnataka India

Hassan
KARNATAKA
573201
India 
Phone  9448064277  
Fax    
Email  profpnrao@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Prasanna Narasimha Rao 
Designation  Principal 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan 
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan Karnataka India

Hassan
KARNATAKA
573201
India 
Phone  9448064277  
Fax    
Email  profpnrao@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Govinda Sharma 
Designation  Associate Professor Dept of Rasashashtra and Bhaishajya Kalpana 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan 
Address  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan Karnataka India

Hassan
KARNATAKA
573201
India 
Phone  9448315270  
Fax    
Email  drgovindsharma@sdmcahhassan.org  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan Karnataka  
 
Primary Sponsor  
Name  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan Karnataka 
Address  B M ROAD THANNIRUHALLA HASSAN 
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 Prasanna Narasimha Rao  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan  B M Road Thanniruhalla
Hassan
KARNATAKA 		 9448064277

profpnrao@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  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: Type 2 Diabetes Mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Nishamalaki choorna   6g BD for 3 months 
Intervention  Novel Ayurvedic choorna   6g BD for 3 months 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Subjects of all gender and age group between 30-60 years will be included.
Subjects with FBS greater than or equal to 126mg/dl and or PPBS greater than or equal to 200mg/dl will be included.
Subjects with HbA1c greater than or equal to 6.5%
Diagnosed cases of Type2 Diabetes Mellitus.
Subjects with and without signs and symptoms of Prameha vis-a-vis Type2 Diabetes Mellitus will be included.
 
 
ExclusionCriteria 
Details  Subjects with history of Diabetes Mellitus associated with complications like diabetic nephropathy, retinopathy, neuropathy, infectious wounds and gangrene will be excluded.
Patients with known systemic disorders like; cardiac illness, renal pathologies, other endocrinal diseases, uncontrolled hypertension, infectious conditions and debilitating illness which interfere with intervention will be excluded.
Patients of Type 2 Diabetes Mellitus who are on OHA and Insulin treatment will be excluded.
Subjects on any other medications, drug and alcohol abuse, Steroids and Estrogen replacement therapy will be excluded.
Pregnant and the lactating women will be excluded.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Fasting Plasma Glucose Level
Two-hour Plasma Glucose Level
HbA1c

 		 3 month 
 
Secondary Outcome  
Outcome  TimePoints 
Clinical symptoms of Diabetes Mellitus.
WHO-QOL.
 		 3 month 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   05/10/2020 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This study is randomized, open, parallel group, single centred trial comparing the safety and efficacy of Novel Ayurvedic choorna 12 gm daily in study group comparing with Nishamalaki choorna 12 gm daily in positive control group for 3 months in 20 each patients with Type 2 Diabetes Mellitus,  that will be conducted in Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan, Karnataka. The primary outcome measures will be estimation of Fasting Glucose Level, Two-hour plasma Glucose level and HbA1c. The secondary outcome measures will be clinical symptoms of Diabetes Mellitus (Pratyatmaka lakshanas of Prameha) and WHO Qualitry of life assessment. 
Close