| CTRI Number |
CTRI/2022/03/041178 [Registered on: 17/03/2022] Trial Registered Prospectively |
| Last Modified On: |
16/03/2022 |
| 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 TO EVALUATE THE MADHUMEHAHARA KARMA ANTIHYPEREGLYCEMIC ACTIVITY OF VASA Adhatoda vasica Nees |
|
Scientific Title of Study
|
A CLINICAL STUDY TO EVALUATE THE MADHUMEHAHARA KARMA (ANTIHYPEREGLYCEMIC ACTIVITY) OF VASA (ADHATODA VASICA) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akshata |
| Designation |
PG Scholar |
| Affiliation |
SDM college of Ayurveda and Hospital Hassan |
| Address |
Sri Dharmastala Manjunatheshawara College of Ayurveda and Hospital Tanniruhalla Hassan
Sri Dharmastala Manjunatheshawara College of Ayurveda and Hospital Tanniruhalla Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
7022555393 |
| Fax |
|
| Email |
drakshatanaveen2330@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Harini A |
| Designation |
Associate professor |
| Affiliation |
SDM college of Ayurveda and Hospital Hassan Hassan |
| Address |
Sri Dharmastala Manjunatheshawara College of Ayurveda and Hospital Tanniruhalla Hassan
Sri Dharmastala Manjunatheshawara College of Ayurveda and Hospital Tanniruhalla Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
9886427831 |
| Fax |
|
| Email |
drharini@sdmcahhassan.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akshata |
| Designation |
PG Scholar |
| Affiliation |
SDM college of Ayurveda and Hospital Hassan |
| Address |
Sri Dharmastala Manjunatheshawara College of Ayurveda and Hospital Tanniruhalla Hassan
Sri Dharmastala Manjunatheshawara College of Ayurveda and Hospital Tanniruhalla Hassan
Hassan
KARNATAKA
573201
India |
| Phone |
7022555393 |
| Fax |
|
| Email |
drakshatanaveen2330@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharamastala Manjunatheshwara College of Ayurveda and Hospital Hassan |
|
|
Primary Sponsor
|
| Name |
Dr Akshata |
| Address |
Sri Dharmastala Manjunatheshawara college of Ayurveda and Hospital Tanniruhalla Hassan |
| Type of Sponsor |
Other [SELF] |
|
|
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 Akshata |
Sri Dharmasthala Manjunatheshwara College of ayurveda and Hospital Hassan |
Sri Dharmasthala Manjunatheshwara College of ayurveda and Hospital Hassan
Hassan
KARNATAKA |
7022555393
drakshatanaveen2330@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
vasa vati |
3 grams TID for 30 days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
subjects above 30 years of either gender suffering from Type two Diabetes mellitus
Fasting blood sugar more than or equal to
126mg/dL
post prandial blood sugar more than equal to 180 mg/dl
|
|
| ExclusionCriteria |
| Details |
Subjects with Diabetes mellitus who are on insulin
subjects with Diabetic complications like Diabetic foot, Diabetic retinopathy and other secondary complications |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| any effect on quality of life |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduction in blood sugar level and urine sugar level |
15th day, 30th day |
| reduction in blood sugar level and reduction in urine sugar level |
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
21/03/2022 |
| 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="0"
Months="4"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a open label study with the title Clinical study to evaluate Madhumehahara karma of Vasa Adhatoda vasica Nees. 30 patients are selected and vasa vati is given at the dose of 2 tablets TID , 3 grams per day. the primary outcome wil be reduction in blood sugar level and urine sugar level. |