| CTRI Number |
CTRI/2025/02/080517 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
10/02/2025 |
| Post Graduate Thesis |
|
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An observational study to check the presence of ketone bodies in urine and blood samples after fat administration |
|
Scientific Title of Study
|
AN OBSERVATIONAL STUDY TO DETERMINE THE STATE OF
ACUTE NUTRITIONAL KETOSIS IN SUBJECTS UNDERGOING
SHODANANGA SNEHAPANA |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
AS Bhavana |
| Designation |
Student |
| Affiliation |
Amrita school of Ayurveda |
| Address |
UG Batch 2020, Room No: 03, Amrita School of Ayurveda, Clappana PO, Kollam
Kollam
KERALA
690525
India |
| Phone |
8892388552 |
| Fax |
|
| Email |
as.bhavana01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aiswarya I V |
| Designation |
Assistant Professor |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Department of Panchakarma,
Amrita School of Ayurveda,
Clappana PO, Kollam
Agasthya Vilasom,
Thattarkonam,
Kollam, Pin: 691005
Kollam
KERALA
690525
India |
| Phone |
8593085580 |
| Fax |
|
| Email |
aiswarya.iv@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Parameswaran Namboothiri |
| Designation |
Professor and Head |
| Affiliation |
Amrita School of Ayurveda |
| Address |
Department of Panchakarma,
Amrita School of Ayurveda,
Clappana PO, Kollam
Kollam
KERALA
690525
India |
| Phone |
9496096694 |
| Fax |
|
| Email |
nambu24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amrita School of Ayurveda, Clappana PO, Kollam, Kerala, Pin- 690525 |
|
|
Primary Sponsor
|
| Name |
Amrita School Of Ayurveda |
| Address |
Amrita School of Ayurveda,
Clappana PO, Kollam
Pin - 690525 |
| Type of Sponsor |
Private 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 |
| AS Bhavana |
Amrita School of Ayurveda |
OP No 2, Department of Panchakarma, Amrita School of Ayurveda, Clappana PO, Kollam, Kerala
Kollam
KERALA |
8892388552
as.bhavana01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Amrita School of Ayurveda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Those who are undergoing Shodananga Snehapana |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Subjects undergoing Shodananga Snehapana |
|
| ExclusionCriteria |
| Details |
Diagnosed cases of systemic illness, kidney disorders, Diabetes Melitus
Subjects on ketodiet or fasting |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Urine Analysis for Ketone bodies using Rothera test and urine dipstick tests
2) Beta hydroxybutyrate estimation using Blood Ketometer on last day of snehapana |
0th day and during all days of snehapana till attainment of samyak snigdha lakshanas |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1)Samyak Snigdha Lakshana assessment using validated tool |
0th day and during all days of snehapana till attainment of samyak snigdha lakshanas |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/02/2025 |
| Date of Study Completion (India) |
30/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/04/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Shodhananga snehapana is the process of administration
of lipids prior to Shodhana karma for the purpose of dosha utklesha. It is
usually given for 3 to7 days till the attainment of samyak snidgha
lakshanas. During the procedure, lipids are administered in high amounts while
restricting the carbohydrate and protein intake. Hence, the probable mode of
action of snehapana has been attributed to ketosis based on this concept of
high fat and low carb diet. Even though the concept of ketosis after snehapana
is enumerated in recent literatures, scientific evidences substantiating the
production of ketone bodies is not available. Hence, an observational study has
been proposed to explore the therapeutic application of snehapana in terms of
acute nutritional ketosis. |