| CTRI Number |
CTRI/2025/02/080877 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
12/02/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Observational |
| Study Design |
Other |
|
Public Title of Study
|
Observational Study for Correlation between Prediabetic with Purvarupa of Prameha |
|
Scientific Title of Study
|
An Observational Study to Correlate Prediabetic Range of HbA1c with Purvarupa of Prameha |
| 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 Manish kumar |
| Designation |
Associate professor |
| Affiliation |
Gaur Brahman Ayurvedic college Rohtak |
| Address |
Room No 21 department of rog nidana evUM vikriti vigyan Gaur Brahman Ayurvedic college Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9416514707 |
| Fax |
|
| Email |
kumardr.manish77@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepti Parashar |
| Designation |
HOD & Professor |
| Affiliation |
Institute for ayurved studies and research kurukshetra |
| Address |
Room No 96 department of Roga Nidan avum vikriti vigyan institute for ayurved studies and research shri krishna ayush university Sector 8 Umri road Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9468319931 |
| Fax |
|
| Email |
deeptiamehta@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepti Parashar |
| Designation |
HOD & Professor |
| Affiliation |
Institute for ayurved studies and research kurukshetra |
| Address |
Room No 96 department of Roga Nidan avum vikriti vigyan institute for ayurved studies and research shri krishna ayush university Sector 8 Umri road Kurukshetra
Kurukshetra
HARYANA
136118
India |
| Phone |
9468319931 |
| Fax |
|
| Email |
deeptiamehta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gaur Brahman Ayurvedic college Rohtak |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [No] |
|
|
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 Manish Kumar |
Room No 21 department of rog nidana evUM vikriti vigyan Gaur Brahman Ayurvedic college |
Brahmanwas Rohtak
Rohtak
HARYANA |
9416514707
kumardr.manish77@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee shri krishna AYUSH university kurukshetra |
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: PRAMEHA-PURVARUPAM, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants having HbA1c level between 5.7- 6.4%.
2. Participants irrespective of gender and religion.
3. Age between 30 to 55 years.
|
|
| ExclusionCriteria |
| Details |
Participants not willing for compliance
Participants who are pregnant or Lactating Mother
Participants who are taking steroids
Known case of Diabetes which are on anti diabetic medication
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prameha purvarupa will be found in the participant of prediabetic range of HbA1c |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Early prevention and easy and early diagnosis of diabetes and its complication can be prevented. |
12 months |
|
|
Target Sample Size
|
Total Sample Size="700"
Sample Size from India="700"
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)
|
23/02/2025 |
| 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="0"
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
|
The escalating prevalence of diabetes mellitus poses a significant global health concern.
Prameha bears a striking resemblance to Diabetes Mellitus. Various research done on Prameha related to its causative factor and treatment. But, No work has been done on the correlation of prediabetic range of HbA1C with Purvarupa of Prameha mentioned in Ayurveda. In this study we select 700 patients those fulfill exclusion and inclusive criteria with HbA1C range 5.7 to 6.4%. Then assessment of pramhea purvarupa will be done. This correlation is need of time to better understand Diabetes Mellitus and Prameha. It will also be helpful in early detection of Prameha in prediabetic stage. So that, further aggravation of disease and complication can be prevented. |