| CTRI Number |
CTRI/2023/06/054055 [Registered on: 16/06/2023] Trial Registered Prospectively |
| Last Modified On: |
12/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective |
| Study Design |
Other |
|
Public Title of Study
|
correlation between causes of Dyslipidemia and other disoders with undigested food and strotas (Medovaha) |
|
Scientific Title of Study
|
An observational study to find out Etiology and Associated Disorders of
Dyslipidemia in relation to Medovaha Stroto Dushti and Ama.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
GARIMA ANAND |
| Designation |
PG scholar |
| Affiliation |
Shri krishna Govt Ayurvedic college and Hospital |
| Address |
Room no 113 P.G. Department of Rog Nidan Avum Vikriti Vigyan, Shri krishna Govt Ayurvedic college and Hospital, Umri road, Sector 8 Kurukshetra Haryana pin code 136118 India
Kurukshetra
HARYANA
136118
India |
| Phone |
9813314327 |
| Fax |
|
| Email |
garima.anand22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
GARIMA ANAND |
| Designation |
PG scholar |
| Affiliation |
Shri krishna Govt Ayurvedic college and Hospital |
| Address |
Room no 113 P.G. Department of Rog Nidan Avum Vikriti Vigyan, Shri krishna Govt Ayurvedic college and Hospital, Umri road, Sector 8 Kurukshetra Haryana pin code 136118 India
Kurukshetra
HARYANA
136118
India |
| Phone |
9813314327 |
| Fax |
|
| Email |
garima.anand22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
GARIMA ANAND |
| Designation |
PG scholar |
| Affiliation |
Shri krishna Govt Ayurvedic college and Hospital |
| Address |
Room no 113 P.G. Department of Rog Nidan Avum Vikriti Vigyan, Shri krishna Govt Ayurvedic college and Hospital, Umri road, Sector 8 Kurukshetra Haryana pin code 136118 India
Kurukshetra
HARYANA
136118
India |
| Phone |
9813314327 |
| Fax |
|
| Email |
garima.anand22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri krishna Govt Ayurvedic college and Hospital, kurukshetra Haryana 136118 |
|
|
Primary Sponsor
|
| Name |
Shri krishna Govt Ayurvedic college and Hospital, kurukshetra Haryana |
| Address |
Shri krishna Govt Ayurvedic college and Hospital, Sector-8, Umri road, kurukshetra Haryana 136118 |
| 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 |
| Dr Deepti Parashar |
Shri krishna Govt Ayurvedic college and Hospital, Sector-8, Umri road, kurukshetra Haryana 136118 |
Room no 113 PG Department of Rog Nidan Avum Vikriti Vigyan Shri krishna Govt Ayurvedic college and Hospital, Sector-8, Umri road, kurukshetra Haryana 136118
Kurukshetra
HARYANA |
09845632011
drdeeptiamehta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E785||Hyperlipidemia, unspecified. Ayurveda Condition: MEDOVAHASROTODUSHTIH , , |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with Dyslipidemia in the age group of 30-70years.
2. Patients who willingly participate and has given written consent.
3. Male and female patients included.
4. Patients with Dyslipidemia and associated disorders (Already Diagnosed). |
|
| ExclusionCriteria |
| Details |
1.Patients below the age group of 30 years and above the age group of 70 years.
2. Patients with cancer.
3. Patients with communicable diseases.
4. Patients who do not participate willingly and has not given written consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Information Collected from each dyslipidemia diagnosed patients on the basis of a questionnaire |
2hours/patient |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study the etiology of Dyslipidemia.
2.To Study other Disorders Associated with Dyslipidaemia.
3. To Study the correlation of Medovahi Stroto Dushti with Dyslipidaemia.
4.To Study the Correlation of Ama with Dyslipidaemia. |
2year |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
01/07/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Increasing prevalence of Dyslipidemia, is a major cause of higher mortality and morbidity.
This affects our Society socially and economically. The purpose of this study is to correlate
eitiology and associated disorders of Dyslipidemia with Medovaha Stroto Dushti Hetu,
Lakshan and Hetu, Lakshana of Ama which will help for prevention of diseases and to decide
the line of treatment.
The overall prevalence of Dyslipidemia is 80%
Lipids are consumed in the form of fats in our body. According to the ayurvedic view Fats are
correlated with Meda or Vasa of the body. By Acharya Charka, Medovaha strotodushti causes
are: lack of exercise, sleep during the daytime, eating a heavy nonvegetarian diet, and excessive
use of Varuni Madya. All these factors are also responsible for the formation of Ama (undigested food). Vitiated
Vataadi Dosha and Raktaadi Dushya with Ama are known as Sama.
Etiological factors and symptoms related to Dyslipidemia,
Medovaha Stroto Dushti and Ama will be recorded with proper questionnaire and observation. |