| CTRI Number |
CTRI/2021/09/036449 [Registered on: 13/09/2021] Trial Registered Prospectively |
| Last Modified On: |
18/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Efficacy of Tryushanadi vati in Madhumeha |
|
Scientific Title of Study
|
Randomized controlled clinical trial of Tryushnadi vati in Madhumeha with special reference to 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 |
Vd Priyanka Shivajirao Ambhure |
| Designation |
PG Scholar Kaya-Chikitsa |
| Affiliation |
Hon Shri Annasaheb Dange Ayurvedic Medical College And Post Graduate Research Centre Ashta |
| Address |
Hon.Shri.Annasaheb Dange Ayurved Medical College,Ashta.Tal-Walwa Dist-Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9923811679 |
| Fax |
|
| Email |
priyankaambhure2106@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Varsha S Khot |
| Designation |
Guide |
| Affiliation |
Hon Shri Annasaheb Dange Ayurvedic Medical College And Post Graduate Research Centre Ashta |
| Address |
Hon.Shri.Annasaheb Dange Ayurved Medical College,Ashta.Tal-Walwa Dist-Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9423565886 |
| Fax |
|
| Email |
drvarshaskhot@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Priyanka Shivajirao Ambhure |
| Designation |
PG Scholar Kaya-Chikitsa |
| Affiliation |
Hon Shri Annasaheb Dange Ayurvedic Medical College And Post Graduate Research Centre Ashta |
| Address |
Hon.Shri.Annasaheb Dange Ayurved Medical College,Ashta.Tal-Walwa Dist-Sangli
Sangli
MAHARASHTRA
416301
India |
| Phone |
9923811679 |
| Fax |
|
| Email |
priyankaambhure2106@gmail.com |
|
|
Source of Monetary or Material Support
|
| Hon Shree Annasheb Dange Ayurvedic College Ashta dist Sangli |
|
|
Primary Sponsor
|
| Name |
Priyanka Shivajirao Ambhure |
| Address |
Hon.Shri.Annasaheb Dange Ayurved Medical College,Ashta.Tal-Walwa Dist-Sangli |
| 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 |
| Vd Priyanka Shivajirao Ambhure |
Hon Shri Annasaheb Dange Ayurved Medical College Ashta |
Hon Shree Annasaheb Dange Ayurvedic College And Post Graduate and Research Centre, Department of Kayachikitsa, Ashta Tal-Walwa Dist-Sangli 416301
Sangli
MAHARASHTRA |
9923811679
priyankaambhure2106@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
T.Metformin |
T.Metformin 500mg BD before meal for 30 days |
| Intervention |
Tryushnadi Vati in Madhumeha |
Tryushnadi Vati 1gm BD Prakbhukt kali for 30 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Willing to give consent to participate in the study.
2. Age group limit - 18 to 70 Years.
3 Irrespective of Sex, religion, education socio-economic & Marital
Status.
4. Patient having Diabetes Mellitus Type 2
Fasting Blood Sugar range – 126 to 200mg/dl,
Post Prandial Blood Sugar range – 200 to 300mg/dl.
5.Patient having Lakshnas of Madhumeha. |
|
| ExclusionCriteria |
| Details |
1. Patients of IDDM (Insulin Dependent Diabetes Mellitus)(DM Type 1).
2.Patient with any major complication of Diabetes Mellitus Type2.
3.Patient with Gestational Diabetes and those in Lactation.
4. Patient having any other major illness |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine efficacy of Tryushnadi Vati in Madhumeha |
4 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To review literature on Madhumeha |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
25/09/2021 |
| 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="6"
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)?
Response - NO
|
|
Brief Summary
|
I am Priyanka Shivajirao Ambhure PG Scholar Kaya-Chikitsa trying to evaluate efficacy of Tryushnadi Vati in the management of Madhumeha. During this trial trying to evaluate the untoward effect of Tryushnadi Vati in Madhumeha as there is no previous work done on Tryushnadi Vati So emphasis will be made to find out easy, cost effective method to control Hyperglycemia with no side effects .
|