| CTRI Number |
CTRI/2024/04/066385 [Registered on: 26/04/2024] Trial Registered Prospectively |
| Last Modified On: |
25/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
To study the role of diet pattern, especially eating before digestion of previous meal, in the causation of Metabolic Syndrome |
|
Scientific Title of Study
|
Adhyashanam and the risk of Metabolic Syndrome among population aged 30-50 years: a case – control 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 Deepty Nair |
| Designation |
PhD Scholar |
| Affiliation |
PDEAs College of Ayurved and Research Centre |
| Address |
PDEAs College of Ayurved and Research Centre Sector No. 27 Pradhikaran Nigdi Pimpri Chinchwad Maharashtra 411044
Sector No. 27 Pradhikaran Nigdi Pimpri Chinchwad Maharashtra 411044
Rajkot
GUJARAT
360020
India |
| Phone |
08547800913 |
| Fax |
|
| Email |
deeps_ayurjyoti@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arti Rajendra Firke |
| Designation |
Associate Professor |
| Affiliation |
PDEAs College of Ayurved and Research Centre |
| Address |
DEAs College of Ayurved and Research Centre Sector No. 27 Pradhikaran Nigdi Pimpri Chinchwad Maharashtra 411044
Sector No. 27 Pradhikaran Nigdi Pimpri Chinchwad Maharashtra 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
8888845674 |
| Fax |
|
| Email |
arfirke@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Deepty Nair |
| Designation |
PhD Scholar |
| Affiliation |
PDEAs College of Ayurved and Research Centre |
| Address |
PDEAs College of Ayurved and Research Centre Sector No. 27 Pradhikaran Nigdi Pimpri Chinchwad Maharashtra 411044
Sector No. 27 Pradhikaran Nigdi Pimpri Chinchwad Maharashtra 411044
Pune
MAHARASHTRA
411044
India |
| Phone |
8547800913 |
| Fax |
|
| Email |
deeps_ayurjyoti@yahoo.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurved and Research Centre Sector No 27 Pradhikaran Nigdi Pimpri Chinchwad Maharashtra India 411044 |
|
|
Primary Sponsor
|
| Name |
Dr Deepty Nair |
| Address |
Sarani Vanoor Road Alathur Palakkad District Kerala India 678541 |
| Type of Sponsor |
Other [Self] |
|
|
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 Deepty Nair |
PDEAs College of Ayurved and Research Centre |
Swasthavritta OPD, Sector 27 Pradhikaran Nigdi Pimpri Chinchwad Maharashtra 411044
Pune
MAHARASHTRA |
8547800913
deeps_ayurjyoti@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC PDEAs College of Ayurved and Reserach Centre Nigdi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E668||Other obesity. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Diagnosed patients of Metabolic Syndrome or subjects having any three of following 5 criteria i.e., fasting plasma glucose ≥110 mg/dl, serum triglycerides ≥150 mg/dl, serum HDL cholesterol <40 mg/dl, BP ≥130/85 mmHg, Hypertension, Dyslipidemia, or on medication for DM, HTN or Dyslipidemia; and waist girth >102 cm.
2. Patient of either sex, male and female, in the age group 30-50 years.
3. Healthy family members of either sex, male and female, (not satisfying the diagnostic criteria for Metabolic Syndrome) in the age group 30-50 years will be included as the controls for the study.
|
|
| ExclusionCriteria |
| Details |
1. Patients with secondary complications of metabolic syndrome including cardio vascular disease, stroke, cancer and renal diseases. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| oTo study the association between dietary patters especially Adhyasanam & Metabolic Syndrome among the population aged 30-50 years. |
18 months (at the end of the study and data analysis) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
o To study the association between Adhyashanam & Blood Glucose values among the population aged 30-50 years.
o To study the association between Adhyashanam & Lipid Profile among the population aged 30-50 years.
o To study the association between Adhyashanam & Blood Pressure among the population aged 30-50 years.
o To study the association between Adhyashanam & BMI among the population aged 30-50 years.
|
at the time of screening & enrollement of study participants |
|
|
Target Sample Size
|
Total Sample Size="210"
Sample Size from India="210"
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)
|
06/05/2024 |
| 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 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
|
• Based on the Inclusion and Exclusion criteria including clinical and laboratory assessment -Anthropometric Assessment (Height, Weight, BMI, Waist Circumference), General Assessment (Blood Pressure) Laboratory Assessment (Serum Triglycerides, Serum HDL, Fasting Blood Glucose Level) subjects will be recruited to the case group. • Based on the Inclusion and Exclusion criteria matched controls will be recruited to the control group from among the healthy family members of the cases. • Informed Consent will be collected from both cases and controls. • Initial assessment will be done including physical examination and laboratory investigations and data will be recorded. • Data collection to assess the practice of Adhyashanam will be done using the validated questionnaire. • Data analysis and comparison among the groups will be done and Odd’s ratio will be calculated to find the association between Adhyashanam and Metabolic Syndrome. • Risk association will be assessed using chi square test. |