| CTRI Number |
CTRI/2025/11/098205 [Registered on: 28/11/2025] Trial Registered Prospectively |
| Last Modified On: |
27/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Agnisara Kriya on Lipid Profile in Patients with High cholesterol level. |
|
Scientific Title of Study
|
Effect of Agnisar kriya on Lipid Profile in Patients with Dyslipidemia A single group pre post 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 K Vijayalakshmi |
| Designation |
PG Scholar |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Department of Yoga,
Second Floor,
PG Block,
Government Yoga and Naturopathy Medical College and Hospital,
Arumbakkam,
chennai,
Tamil Nadu,
India
Chennai
TAMIL NADU
600106
India |
| Phone |
8838551423 |
| Fax |
|
| Email |
viji31121998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K S Lakshmi |
| Designation |
Professor and Head of the Department, Department of Yoga |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Department of Yoga,
Second Floor,
PG Block,
Government Yoga and Naturopathy Medical College and Hospital,
Arumbakkam,
Chennai 600106
Tamil Nadu,
India
Chennai
TAMIL NADU
600106
India |
| Phone |
9841073029 |
| Fax |
|
| Email |
lakshmikaran28@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr K Vijayalakshmi |
| Designation |
PG Scholar |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Department of Yoga,
Second Floor,
PG Block,
Government Yoga and Naturopathy Medical College and Hospital,
Arumbakkam,
chennai,
Tamil Nadu,
India
Chennai
TAMIL NADU
600106
India |
| Phone |
8838551423 |
| Fax |
|
| Email |
viji31121998@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government yoga and Naturopathy Medical college and Hospital,Arumbakkam,chennai 600106,Tamil nadu,India |
|
|
Primary Sponsor
|
| Name |
Government Yoga and Naturopathy Medical College and Hospital, Chennai. |
| Address |
Government Yoga and Naturopathy Medical college and Hospital,
Arumbakkam,
Chennai,
Tamil Nadu 600106
India |
| 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 K Vijayalakshmi |
Government Yoga and Naturopathy Medical College and Hospital |
Department of Yoga,
Second Floor,
PG Block,
Arumbakkam,
chennai 600106
Tamil nadu,
India
Chennai
TAMIL NADU |
08838551423
viji31121998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Yoga and Naturopathy Medical College and Hospital, Chennai, Institutional Ethical Committee. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E785||Hyperlipidemia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Agnisar Kriya |
SWANA PRANAYAMA (As a preparatory practice):
Participants will be asked to sit in a comfortable, meditative posture with their arms straight, body slightly leaning forward, and head held erect. Participants will be asked to inhale and exhale through the mouth, with lips rounded. During exhalation, participants will open their mouths wide and extend their tongue, while pulling the navel inward; inhalation will be performed by pushing the abdomen outward. This sequence is repeated 20 times without strain. After the “panting” phase, the abdomen is relaxed. Participants then resume deep breathing and continue normal breathing for 10–12 breaths. This completes one round. Up to three rounds may be practiced a day for 5 days
Main Intervention Protocol (3 Weeks Follow Up):
Following the initial preparatory phase, participants will engage in a structured practice consisting of 1 minute of Agnisar Kriya, immediately followed by 1 minute of relaxation. This alternating cycle of kriya and rest will continue for a total duration of 20 minutes per session. The same routine will be consistently practiced five times a week, over a three-week period.
Participants will be asked to stand with the feet shoulder width apart, lean forward and place both palms on the knees. The participant will be asked to keep the arm straight and bend the knees slightly. The participant will be asked to look towards the abdomen and then to open the mouth and extend the tongue. Then, the participant will be asked to contract and expand the abdomen while breathing in and out for 30 times. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria:
• Adults aged 20-45 years
• Both Male and female
• Clinically diagnosed Dyslipidemia individuals based on the National Cholesterol Education Program (NCEP) guidelines following either one or a combination of abnormalities in serum lipid levels. |
|
| ExclusionCriteria |
| Details |
• Participants who cannot perform Agnisara kriya
• Presence of major comorbidities such as uncontrolled diabetes, hypertension, chronic kidney
disease, liver disorders, cardiovascular disease or gastrointestinal disorders
• Skin conditions or infections over the abdominal or liver region
• Pregnant or lactating women
• Participating in any other clinical trial in the past 3 months
• Alcohol or substance abuse |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Lipid Profile including Total cholesterol, Triglyceride, High Density Lipoprotein, Low Density Lipoprotein. |
Lipid Profile including Total cholesterol,
Triglyceride, High Density Lipoprotein, Low Density Lipoprotein will be assessed on Day 1st before the intervention and on the of last day after the three weeks of intervention Period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fasting Blood Glucose Level (FBS) and Post Prandial Blood Glucose Level (PPBS) |
Fasting Blood Glucose Level (FBS) and Post Prandial Blood Glucose Level (PPBS) will be assessed on Day 1st before the intervention and on the of last day after the three weeks of intervention Period. |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/01/2026 |
| 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
|
A pre and post study group design will be adopted for this study. 30 participants will be recruited from Government Yoga and Naturopathy Medical College and Hospital, Chennai. All participants will be assessed before and after the intervention period to evaluate the effect of yogic practices on biochemical parameters.
Participants will undergo Swana Pranayama as a preparatory practice, followed by Agnisar Kriya as the main intervention. Swana Pranayama will be practiced for 5 rounds daily for 5 days, as a preparatory technique for 1week and Agnisar Kriya will be practiced for 20 minutes (1 minute intervention followed by 1 minute relaxation), once daily, 5 days a week for next 3 weeks.
Assessments of Primary Outcome are Lipid profile - including Total Cholesterol (TC), Triglycerides (TG), High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL) and Secondary Outcomes are Fasting Blood Sugar (FBS) and Postprandial Blood Sugar (PPBS) will be recorded before and after the 3 weeks of intervention period. |