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
|
|
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
|
|
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. |