| CTRI Number |
CTRI/2024/05/067996 [Registered on: 28/05/2024] Trial Registered Prospectively |
| Last Modified On: |
28/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of symptoms in Prediabetic patients by questionnaire |
|
Scientific Title of Study
|
Development of questionnaire and assessment of Prameha poorvaroopa in Prediabetes – Cross sectional study |
| 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 Nayana G |
| Designation |
Post graduate scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan |
| Address |
Department of Roga Nidana Evam Vikruti Vignana,
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,
Hassan -573201
Hassan
KARNATAKA
573201
India |
| Phone |
8762548673 |
| Fax |
|
| Email |
nayanagar04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahesh Hirulal |
| Designation |
Associate professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan |
| Address |
Department of Roga Nidana Evam Vikruti Vignana,
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,
Hassan -573201
Hassan
KARNATAKA
573201
India |
| Phone |
9620854148 |
| Fax |
|
| Email |
maheshhirulal@sdmcahhassan.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahesh Hirulal |
| Designation |
Associate professor |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan |
| Address |
Department of Roga Nidana Evam Vikruti Vignana,
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,
Hassan -573201
Hassan
KARNATAKA
573201
India |
| Phone |
9620854148 |
| Fax |
|
| Email |
maheshhirulal@sdmcahhassan.org |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,
Hassan 573201, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan |
| Address |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital,
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 Nayana G |
Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan |
IPD and OPD under all the departments of Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital, Hassan 573201
Hassan
KARNATAKA |
8762548673
nayanagar04@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 |
(1) ICD-10 Condition:R730||Abnormal glucose. Ayurveda Condition: PRAMEHA-PURVARUPAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. The screened patients will be enrolled for the study on diagnosis of pre diabetes by ICMR criteria for diagnosis of pre diabetes.
A. FPG -100-125mg/dl (Fasting is defined as no caloric intake for at least 8 hours.)
Or
B. 2- hours plasma glucose 140-199 mg/dl during an OGTT
Or
C. HBA1C 5.7-6.4%
2. Within the age group of 18 to 60 years of any gender
3. Participants willing to participate in the study and ready to sign the written consent form
|
|
| ExclusionCriteria |
| Details |
1. Known case of any type of diabetes mellitus
2. Known case of HIV, Hepatitis, Tuberculosis, Pancreatitis, Pancreatic tumor or any other endocrinal disorders
3. Known case of any coexisting illness being capable of masking or promoting the pre diabetic symptoms
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Sample size calculated as 100 based on prevalence of pre-diabetes and Prameha Poorvaroopa are assessed in those individuals who pass the inclusion criteria |
The outcome will be assessed at the baseline with the questionnaire specially prepared for the assessment of Prameha Poorvaroopa in prediabetes, further follow up will not be done |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessing pre-diabetic patients with framed questionnaire & recording prevalence of each Prameha Poorvaroopa in pre-diabetic individual |
The outcome will be assessed at the baseline with the questionnaire specially prepared for the assessment of Prameha Poorvaroopa in prediabetes, further follow up will not be done |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
13/06/2024 |
| 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) |
Open to Recruitment |
|
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
|
Lack of preventive care during pre-diabetic stage increasing the incidence of diabetes mellitus worldwide. Though there are a number of warning signs of pre-diabetes explained in contemporary health sciences, they are neglected or masked by other health conditions. on the other hand Prameha Poorvaroopas are unique symptomatology explained which appear on the course of manifestation of Prameha. Thus application of Prameha Poorvaroopa lakshanas in identifying warning sign in pre-diabetic patient would help in early diagnosis. As Presently there is no standard questionnaire to assess the classically mentioned Prameha Poorva roopa lakshanas, in this study an attempt will be made to frame the questionnaire based on classically mentioned Prameha Poorva roopa lakshanas and used to asses Prameha Poorvaroopa lakshanas in pre-diabetic patients which helps in early diagnosis.
|