| CTRI Number |
CTRI/2025/01/078995 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
19/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To study the relation between causes of Diabetes and Prediabetic condition with
special reference to HbA1C. |
|
Scientific Title of Study
|
An observational study To find relation between Prameha Hetu and Prediabetic
condition with special reference to HbA1C |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Kavita Balasaheb Argade |
| Designation |
B.A.M.S. PG Scholar |
| Affiliation |
Department of Rognidan Avum Vikriti vigyana |
| Address |
Ayurved Rugnalay and sterling multispeciality hospital pathology lab
room no. 115 sector no.27 pradhikaran nigdi pune. PDEAs College
of Ayurved And Research Centre Nigdi Pune
Ayurved Rugnalay and sterling multispeciality hospital pathology lab
room no. 115 sector no.27 pradhikaran nigdi pune. PDEAs College
of Ayurved And Research Centre Nigdi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9657075222 |
| Fax |
|
| Email |
kavitaargade2012@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh H Mhaske |
| Designation |
Associate Professor |
| Affiliation |
Department of Rognidan Avum Vikriti vigyana |
| Address |
Ayurved Rugnalay and sterling multispeciality hospital pathology lab
room no. 115 sector no.27 pradhikaran nigdi pune. PDEAs College
of Ayurved And Research Centre Nigdi Pune
Ayurved Rugnalay and sterling multispeciality hospital pathology lab
room no. 115 sector no.27 pradhikaran nigdi pune. PDEAs College
of Ayurved And Research Centre Nigdi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9130805556 |
| Fax |
|
| Email |
dr.rajeshmhaske@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Kavita Balasaheb Argade |
| Designation |
B.A.M.S. PG Scholar |
| Affiliation |
Department of Rognidan Avum Vikriti vigyana |
| Address |
Ayurved Rugnalay and sterling multispeciality hospital pathology lab
room no. 115 sector no.27 pradhikaran nigdi pune. PDEAs College
of Ayurved And Research Centre Nigdi Pune
Ayurved Rugnalay and sterling multispeciality hospital pathology lab
room no. 115 sector no.27 pradhikaran nigdi pune. PDEAs College
of Ayurved And Research Centre Nigdi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9657075222 |
| Fax |
|
| Email |
kavitaargade2012@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research Centre Nigdi Pune Maharashtra 411044 |
|
|
Primary Sponsor
|
| Name |
Not Applicable |
| Address |
Not Applicable |
| Type of Sponsor |
Other [Not Applicable] |
|
|
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 Kavita Balasaheb Argade |
Pathology lab room no 115 ,PDEAs Ayurved Rugnalaya and Sterling Multispeciality Hospital ARSMH |
Near Sant Dyaneshwar
Chowk,Sector No.
27,Pradhikaran
,Nigdi,Pune 411044
Pune
MAHARASHTRA
Pune
MAHARASHTRA |
9657075222
kavitaargade2012@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Pune District Education Associations College of Ayurved and Research Centre Sector No 25 Pradhikaran Nigdi Pune 411044 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E00-E89||Endocrine, nutritional and metabolic diseases. Ayurveda Condition: PRAMEHAH, |
|
|
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 |
1. Age group between 30 to 60 years.
2. Person’s having HbA1C 5.7%-6.4% will be selected
3.Patient will be selected Irrespective of their Gender, religion, socio-economical
class and marital status. |
|
| ExclusionCriteria |
| Details |
1.Diabetes Mellitus and its complications, Patients having Liver diseases, kidney
diseases, malignancies and major illnessess will be excluded.
2.Patient’s on sterodial medications, Alcoholic person’s will be excluded.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the relation between causes of diabetes and Prediabetic condition with
special reference to HbA1C. |
10 months |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/02/2025 |
| 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="5" |
|
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
|
1.Title An observational study to find relation between Prameha Hetu and Prediabetic
condition with special reference to HbA1C.
2.Objectives Primary Objective To study the relation between Prameha Hetu and Prediabetic condition with
special reference to HbA1C.
3. Methodology I. APPROPRIATE STUDY DESIGN –
It is an Observational study. II.STUDY SETTING –
The proposed study will be done in three levels. LEVEL 1 (CONCEPTUAL) – Ayurvedic literature regarding Hetu of Prameha vyadhi,
Prediabetic Condition and HbA1C will be studied. LEVEL 2 (OBSERVATIONAL) – Relation between Prameha Hetu and Prediabetic
condition with special reference to HbA1C will be observed. LEVEL 3 (ANALYSIS) – Analysis of generated data will be performed for Qualitative
and Quantitative data for result. 1)STUDY PLACE –
OPD & IPD of Institutional Hospitals and nearby Hospitals of PCMC area.
2)STUDY DURATION –
18 Months.
3)I.STUDY POPULATION –
Persons having Prediabetic condition Should be taken & Prameha Hetu will be
observed.
4).SAMPLE SIZE –
4(pq)/e2
P=Prevalence rate=10.3%=0.10 [9]
q=(1-p)=(1-0.10)=0.9
Error=0.08 Sample size=4(pq)/e2
=4(0.10*0.9/0.08*0.08
=4(0.09)/0.0064
=56.25
So will take 60 persons.
5) APPROPRIATE SAMPLING TECHNIQUE –
Purposive sampling technique will be taken.
6)METHOD OF SELECTION OF STUDY SUBJECT .
A. INCLUSION CRITERIA – 1. Age group between 30 to 60 years. 2. Person’s having HbA1C 5.7%-6.4% will be selected . 3..Patient will be selected Irrespective of their Gender, religion, socio-economical
class and marital status.
B.EXCLUSION CRITERIA – 1.Diabetes Mellitus and its complications, Patients having Liver diseases, kidney
diseases, malignancies and major illnessess will be excluded. 2.Patient’s on sterodial medications, Alcoholic person’s will be excluded |