| CTRI Number |
CTRI/2025/02/080713 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
15/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Premonitoring symptoms of prameha as risk factor in obese patients |
|
Scientific Title of Study
|
An observational study of poorvaroopa of prameha as a risk factor in obese patients 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 |
Sahil sharma |
| Designation |
PG Scholar |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Room no 143 pg department of rog nidaan evum vikruti vigyan chaudhary brahm prakash ayurved charak sansthan khera dabar najafgarh new delhi 110073
Room no 143 pg department of rog nidaan evum vikruti vigyan chaudhary brahm prakash ayurved charak sansthan khera dabar najafgarh new delhi 110073
South West
DELHI
110073
India |
| Phone |
7006128938 |
| Fax |
|
| Email |
saahilsingh.05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Vidula Gujjarwar |
| Designation |
Head of Department |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Room no 143 pg department of rog nidaan evum vikruti vigyan chaudhary brahm prakash ayurved charak sansthan khera dabar najafgarh new delhi 110073
Room no 143 pg department of rog nidaan evum vikruti vigyan chaudhary brahm prakash ayurved charak sansthan khera dabar najafgarh new delhi 110073
South West
DELHI
110073
India |
| Phone |
9990174348 |
| Fax |
|
| Email |
shreemahalaxmi1969@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PROF Dr VIDULA GUJJARWAR |
| Designation |
HEAD OF DEPARTMENT |
| Affiliation |
CHAUDHARY BRAHM PRAKASH AYURVED CHARAK SANSTHAN |
| Address |
PG DEPARTMENT OF ROG NIDAN EVUM VIKRITI VIGYAN CHAUDHARY BRAHM PRAKASH AYURVED CHARAK SANSTHAN KHERA DABAR NAJAFGARH NEW DELHI 110073
PG DEPARTMENT OF ROG NIDAN EVUM VIKRITI VIGYAN CHAUDHARY BRAHM PRAKASH AYURVED CHARAK SANSTHAN KHERA DABAR NAJAFGARH NEW DELHI 110073
South West
DELHI
110073
India |
| Phone |
9990174348 |
| Fax |
|
| Email |
shreemahalaxmi1969@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh New Delhi 110073 India |
|
|
Primary Sponsor
|
| Name |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Khera Dabar Najafgarh New Delhi 110073 |
| Type of Sponsor |
Government 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 |
| SAHIL SHARMA |
CHAUDHARY BRAHM PRAKASH AYURVED CHARAK SANSTHAN |
PG DEPARTMENT OF ROG NIDAN EVUM VIKRITI VIGYAN CHAUDHARY BRAHM PRAKASH AYURVED CHARAK SANSTHAN KHERA DABAR NAJAFGARH NEW DELHI 110073
South West
DELHI |
7006128938
saahilsingh.05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC CBPACS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E669||Obesity, unspecified. Ayurveda Condition: MEDOVRUDDHIH, |
|
|
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 Patients of either gender between age of 18 to 60 years
2 Already diagnosed obese patients with BMI more than 30
3 Patients willing to provide consent to participate in the study |
|
| ExclusionCriteria |
| Details |
1 Pregnant women and lactating mothers
2 Patients with TYPE 1 Diabetes Mellitus
3 Patients with serious hepatic cardiac or renal disorder
4 Patients having any other metabolic disorder
5 Drug induced serious illness |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Pre diagnosing patients who are prone to be Diabetic without any lab investigations
|
90 DAYS
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
This study will be beneficial in prevention as well as management of prameha in obese patients by identifying the poorvarupa of prameha as a risk factor
|
90 DAYS |
|
|
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)
|
03/03/2025 |
| 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 Yet Recruiting |
| 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
|
According to acharya Charaka there are 20 subtypes of Prameha due to the interaction of the three
Doshas and 10 Dushyas (disturbed functioning of the principles that support the various bodily
tissues); several of these subtypes have sweet urine, whereas some of them have different coloration
of the urine, highlighting the inflammatory conditions involved in the metabolic syndrome. This
disease has close ties to Sthaulya (i.e., obesity). With regard to diabetes mellitus, Sahaja Prameha
and Jataj Pramehi correlate with type 1 diabetes; Apathyanimittaja Prameha correlates with type 2
diabetes. The relationship between obesity and type 2 diabetes has been known for decades and the recent
important increase in such diseases represents a major medical problem worldwide. Medical advancements made so far could have done little to find a real cure for diabetes and so the
strategy to hold it largely revolves around its clinical management and prevention.
Being a systemic illness, this is well perceived that it affects almost every tissue and system of the
body. Diabetes management which largely revolves around glycemic control also do not adequately ensure
the prevention of complications owing to inherent complexities associated with obtaining a tight
glycemic control.Main limitations associated with diabetes prevention programs are lack of sensitization among the
people about prevention when they apparently do not have clear warning signs associated with
future disease In absence of clear warning signs, people fail to appreciate the importance and need of strategies
which can prevent diabetes in future. Near absence of clinical features during the stage of pre
diabetes, occasional presence of diabetes without classical features of polyphagia, polyuria and
polydipsia and uncertainty of time duration needed for converting a pre-diabetic into diabetic are
other prominent reasons of non-adherence of people with diabetes prevention programs. A hypothesis was proposed that on the basis of exploration of pre-diabetic features as are identified
9
in ayurveda as poorvaroopa of prameha, a more realistic sensitization among prediabetes people
may be done. Once identified, these pre diabetics can be warned and prompted for steps to avert the
disease by showing the proximity of their prediabetes features with clinical diabetes It was further hypothesized that if the early clinical signs and symptoms of diabetes are found to
have a proven association with upcoming diabetes, on the basis of this information, the patient
having early sign and symptoms may be warned of the future consequences and hence can be
motivated for adhering to the preventive strategies. As research work has been done on prameha w.s.r to Diabetes mellitus,but the role
of Poorvaroopa of Prameha as a risk factor in obese patients is yet to be
ascertained.This study will help to validate the fundamentals inscribed in Samhita
which inculcates the Poorvaroopa of Prameha as a risk factor in obese patients |