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CTRI Number  CTRI/2017/05/008680 [Registered on: 26/05/2017] Trial Registered Retrospectively
Last Modified On: 04/05/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Single Arm Study 
Public Title of Study   A Clinical Study on the Combined Effect of Ayaskriti and Navaka Guggulu - Ayurvedic Medicine in the Management of Madhumeha (Diabetes Mellitus Type 2)  
Scientific Title of Study   An Open Label Single Arm Clinical Study on the Combined Effectiveness of Ayaskriti and Navaka Guggulu in the Management of Madhumeha (Diabetes Mellitus Type 2) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR RUKMANI SHARMA 
Designation  Post Graduate Scholar Department of Kayachikitsa 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan 
Address  BM Road, Thanniruhalla Hassan 573201

Hassan
KARNATAKA
573201
India 
Phone  08172256460  
Fax    
Email  rukurmgshrma@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Girish KJ 
Designation  Professor Dept Of Kayachikitsa 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan 
Address  BM Road Thanniruhalla Hassan 573201

Hassan
KARNATAKA
573201
India 
Phone  08172256460  
Fax    
Email  girideepa@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Girish KJ 
Designation  Professor Dept Of Kayachikitsa 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan 
Address  BM Road Thanniruhalla Hassan 573201

Hassan
KARNATAKA
573201
India 
Phone  08172256460  
Fax    
Email  girideepa@yahoo.co.in  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital BM Road Thanniruhalla Hassan 573201 Karnataka India 
 
Primary Sponsor  
Name  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan 
Address  BM Road Thanniruhalla Hassan 573201 Karnataka India 
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 Rukmani Sharma  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan  OPD 4 DEPARTMENT OF KAYACHIKITSA
Hassan
KARNATAKA 
08172256460

rukurmgshrma@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Madhumeha (Diabetes mellitus type 2),  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Ayaskriti and Navaka Guggulu  Ayaskriti Syrup 20ml thrice daily and Navaka Guggulu 500mg tablet twice daily along with hot water after food for a period of one month 
Comparator Agent  NIL  NA 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Diabetes mellitus Type 2 with Fasting Blood Sugar: 126-180mg/dl, or Post Prandial Blood Sugar: 180-230mg/dl or HbA1c 6.5-8
2. Pre-detected and freshly detected cases.
Patients taking or not taking any other ayurvedic drugs or any allopathic anti-diabetic drugs.
3. Age group between 30-70yrs will be included in the study.
4. Informed written consent will be obtained from the included patients.
 
 
ExclusionCriteria 
Details  1. Diabetes mellitus Type 2 associated other systemic disorders or complications like congestive cardiac failure, chronic renal failure, cerebrovascular disease.
2. Diabetes mellitus Type 2 patients who are on insulin injection.
3. Gestational diabetes, pregnant and the lactating women. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in Fasting blood glucose levels and Post prandial blood glucose levels  30 days 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in signs and symptoms symp(diabetes mellitus type 2)  30 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   N/A 
Date of First Enrollment (India)   03/03/2017 
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)  Open to Recruitment 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Madhumeha is considered as one of the ashtamahagad as caused by the involvement of tridosha and dashadushyas. As Madhumeha is krichrasadya or yapya, a good control and effective management is ultimate aim to reduce the risk of the development of further complications. It is quite difficult to formulate a single drug effective on all clinical manifestations of Madhumeha.

With this background there is a need for drugs from herbal source which is effective, with least adverse effects and palatable so that patient can use the drug lifelong to control Madhumeha. The study focus on assessing the combined effect of Ayuskriti and Navaka Guggulu, a preparation mentioned for the management of Madhumeha. The combined effect of these drugs and properties like kledahara, medohara, dravashoshana, ushnavirya, and katuvipakan would be beneficial in the management of Madhumeha. Ayaskritiis an arishta yoga which has the combination of Asanadigana having Kashaya-Tiktapradhanarasa, katuvipaka, and ushnavirya. Similarly Navaka Guggulu contains triyushana and triphala which is deepaniya and pachaniya, laghu and rookshan and guggulu with medohara properti. The combination of these drugs will be helpful in the Dhosaprathyanika and Vyadiprathyanika Chikitsa of Madhumeha. And also after thorough review of research in Ayurveda other thesis data base did not yield any result in relation to the combination of Ayaskriti and Navaka Guggulu.

 

In the preset study, open label single arm clinical trial at OPD or IPD basis would be done with pre and post-test design for the included 30 patients. Pre diagnosed and freshly diagnosed patients will be taken.  Than  Ayaskriti 20 ml and Navaka Gugguku 500 mg thrice daily in the morning and night will be administered after food with ushnodaka as anupana for the 30 days. After the 30 days again the blood investigations will be done to rule out the effect of drugs administered. Hence the entire treatment will be completed in 30  days.

The patient will be assessed on the 1st day and 30th day with investigations like FBS, PPBS, Blood routine, lipid profile and urine routine. Assessment would be done based on subjective and objective parameters and would also be monitored for Adverse Drug Reactions or Adverse Drug Effects or other concurrent illness.

The collected data will be tabulated and analyzed using Statistical Package for Social Sciences (SPSS) version 20.Statistical tests like paired t test, repeated measure anova will be done.

 
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