| CTRI Number |
CTRI/2023/12/060914 [Registered on: 28/12/2023] Trial Registered Prospectively |
| Last Modified On: |
22/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To assess Asthikshaya and Medovrudhi in high bmi individual |
|
Scientific Title of Study
|
A cross sectional analytical study to evaluate relation
between Medovruddhi and Asthikshaya in high B.M.I.
individuals |
| 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 Sanket Yadav |
| Designation |
PG Scholer |
| Affiliation |
PDEAs college of Ayurveda research center Nigdi Pune |
| Address |
Department of Kriya Sharir Ground floor PDEAs college of Ayurveda research center Nigdi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9421265179 |
| Fax |
0 |
| Email |
sanketyadav07@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati Chobhe |
| Designation |
HOD and Professor |
| Affiliation |
PDEAs college of Ayurveda research center Nigdi Pune |
| Address |
Department of Kriya Sharir Ground floor PDEAs college of Ayurveda research center Nigdi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9850716124 |
| Fax |
0 |
| Email |
swatichobhe@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanket Yadav |
| Designation |
PG Scholer |
| Affiliation |
PDEAs college of Ayurveda research center Nigdi Pune |
| Address |
Department of Kriya Sharir Ground floor PDEAs college of Ayurveda research center Nigdi Pune
Pune
MAHARASHTRA
411044
India |
| Phone |
9421265179 |
| Fax |
0 |
| Email |
sanketyadav07@gmail.com |
|
|
Source of Monetary or Material Support
|
| PDEAs College of Ayurveda and research center Nigdi Pune |
|
|
Primary Sponsor
|
| Name |
Dr Sanket Yadav |
| Address |
Department of Kriya Sharir Ground floor PDEAs college of Ayurveda research center Nigdi Pune |
| 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 Sanket Yadav |
PDEAs College of Ayurveda and research centre Nigdi Pune |
PDEAs College of Ayurveda and research centre kriya sharir department ground floor Sector No 25 Nigdi Pradhikaran Pune 411044
Pune
MAHARASHTRA |
9421265179
0
sanketyadav07@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PDEAs college of ayurvedic research Akurdi Pune Institutional Ethics committee I for Human Resource |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E663||Overweight. 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 |
49.00 Year(s) |
| Gender |
Both |
| Details |
BMI more than 25 |
|
| ExclusionCriteria |
| Details |
Pregnacy
Acute or Chronic illness
Exercising like Pranayam gym swimming running more than 45 minutes |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find relation between Medovruddhi and Asthikshaya in high BMI indivuals when compared with normal BMI individuals |
One time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
10/01/2024 |
| 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="0"
Months="3"
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
|
Lifestyle disease tends to rise with higher BMI. In Ayurveda Medovruddhi can be objectively studied with high BMI. The Dhatus mentioned as per Ayurveda are sequentially synthesized and nourished. All seven Dhatus are interlinked with each other which is called Dhatusneh parampara. By this rule Medo Dhatu and Asthi Dhatu poshan is interdependent. But In Medovruddhi often Asthikshaya is observed. This will be studied under this topic by observing symptoms of Medovruddhi and Asthikshya. |