| CTRI Number |
CTRI/2024/04/065338 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
30/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross sectional Observational study |
| Study Design |
Other |
|
Public Title of Study
|
Observational Study of Dhatupak Lakshan in Madhumeha (Type II Diabetis Mellitus) with Special Reference to HbA1c Glycosylated Heamoglobin.
|
|
Scientific Title of Study
|
Observational Study of Dhatupak Lakshanas in Madhumeha (Type II DM)with Special Reference to HbA1c.
|
| 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.Pranali S.Bhende (Kanakdande) |
| Designation |
Associate Professor |
| Affiliation |
Govt. Ayurved College, Nagpur |
| Address |
Government Ayurved College, Nagpur
Admitted for PhD Scholar in DMM AYURVED MAHAVIDYALAYA, YAVATMAL.
Yavatmal
MAHARASHTRA
440024
India |
| Phone |
9867351304 |
| Fax |
|
| Email |
vdpranali@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R.J.Mundane |
| Designation |
Professor |
| Affiliation |
DMM AYURVED MAHAVIDYALAYA YAVATMAL |
| Address |
DMM AYURVED MAHAVIDYALAYA YAVATMAL,SHIVAJINAGAR ARNI ROAD,YAVATMAL ,MAHARASHTRA INDIA
DMM AYURVED MAHAVIDYALAYA YAVATMAL,SHIVAJINAGAR ARNI ROAD,YAVATMAL ,MAHARASHTRA INDIA
Yavatmal
MAHARASHTRA
445001
India |
| Phone |
9850719571 |
| Fax |
|
| Email |
rajivmundane19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Pranali S Bhende (Kanakdande) |
| Designation |
Associate Professor |
| Affiliation |
Govt.Ayurved College Nagpur |
| Address |
Government Ayurved college Nagpur
Admitted for PhD (Scholar in DMM AYURVED MAHAVIDYALAYA YAVATMAL.
Yavatmal
MAHARASHTRA
440024
India |
| Phone |
9867351304 |
| Fax |
|
| Email |
vdpranali@gmail.com |
|
|
Source of Monetary or Material Support
|
| DMM AYURVED MAHAVIDYALAYA YAVATMAL,SHIVAJINAGAR ARNI ROAD,YAVATMAL ,MAHARASHTRA INDIA 445001 |
|
|
Primary Sponsor
|
| Name |
Dr Pranali SBhende Kanakdande |
| Address |
DMM AYURVED MAHAVIDYALAYA YAVATMAL,SHIVAJINAGAR ARNI ROAD,YAVATMAL ,MAHARASHTRA INDIA |
| Type of Sponsor |
Other [Dr.Pranali S.Bhende (Kanakdande)] |
|
|
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 Pranali S Bhende |
Govt.Ayurved college Nagpur |
Rognidan OPD. Room no.4
Raje Raghuji Nagar Nagpur 440024
Nagpur
MAHARASHTRA |
9867351304
vdpranali@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITEE REPOR(As per Circular No.03/2022 dated 22/02/2022) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R688||Other general symptoms and signs. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, (2) ICD-10 Condition:E118||Type 2 diabetes mellitus with unspecified complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with known case of Diabetes Mellitus Type II with HB1AC greater than 8 percent
|
|
| ExclusionCriteria |
| Details |
Patients with HB1AC below 8 percent
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study Dhatupak lakshan in raised HB1AC
in Madhumeha (Type II DM)
|
one time observation with follow up of 1month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To study association between Dhatupak lakshan in raised HB1AC in Madhumeha (Type II DM)
|
1 month will be assessed |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
10/04/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
General population Sampleing from target population (Diagnosed patients of Type II DM with HBA1C >8%) Sampling on the basis of Diagnostic criteria ,Inclusion,Exclusion criteria will bemade and Outcome assesement on the basis of given parameters will be study. Collection ,classification,presentation of data on the basis of observations made. Statistical analysis will be done in Statistical software STATA version 14.0 will be used for data analysis Discussion will be made on data analysis Conclusion drawn and data interpreted. |