| CTRI Number |
CTRI/2026/02/104813 [Registered on: 25/02/2026] Trial Registered Prospectively |
| Last Modified On: |
18/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Understanding How Panchakarma Detox Therapy Affects Body Cells in Healthy Adults |
|
Scientific Title of Study
|
An open-label, randomized, exploratory study to evaluate the effect of Shodhananga Snehapan Followed by Virechana on Membrane Lipidomics and Fluidity in Human Cells of Healthy 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 Geeta Devi |
| Designation |
Ph.D Scholar |
| Affiliation |
All India Institute of Ayurveda, New Delhi |
| Address |
7th Floor, Academic block, Department of Panchakarma, All India Institute of Ayurveda,Sarita Vihar, Gautampuri, New Delhi
South
DELHI
110076
India |
| Phone |
8988891400 |
| Fax |
|
| Email |
geeta3747@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Anandaraman P V |
| Designation |
Professor and Head of Department |
| Affiliation |
All India Institute of Ayurveda, New Delhi |
| Address |
Room no.- 704, 7th Floor, Academic block, Department of Panchakarma, All India Institute of Ayurveda,Sarita Vihar, Gautampuri, New Delhi
South
DELHI
110076
India |
| Phone |
9495130595 |
| Fax |
|
| Email |
dr.ananthramsharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Anandaraman P V |
| Designation |
Professor and Head of Department |
| Affiliation |
All India Institute of Ayurveda, New Delhi |
| Address |
Room no.- 704, 7th Floor, Academic block, Department of Panchakarma, All India Institute of Ayurveda,Sarita Vihar, Gautampuri, New Delhi
South
DELHI
110076
India |
| Phone |
9495130595 |
| Fax |
|
| Email |
dr.ananthramsharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda, New Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute of Ayurveda |
| Address |
All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi , 110076 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Geeta Devi |
All India Institute of Ayurveda |
Room no- 705, Department of Panchakarma, All India Institute of Ayurveda, Mathura road, Gautampuri, Sarita Vihar New Delhi 110076
South
DELHI |
8988891400
geeta3747@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Fit for Virechana |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | virecana-karma, विरेचन-कर्म | (Procedure Reference: , Procedure details: 1.The subjects will be given deepana-pachana with Panchakola churna 3gm with lukewarm water BD before food for 3-7 days/until the attainment of nirama lakshan.
2. Then the subjects will be given shodhananga snehpana with Indukant ghrita early morning on empty stomach before onset of hunger in arohana matra i.e escalating dose starting with 30ml & thereafter increasing the dose everyday by calculating the time taken for digestion of Sneha for 5-7days or till the attainment of samyak snigdha lakshana.
3.After attaining samyak snighdha lakshanas, the patient will be subjected to Sarvanga abhyanga with Ksheerabala taila & Bashpa sweda with Dashmool Kwatha in the morning for 3 days (including the day of virechana).
On the previous day of virechana, the patient should be given anabhishyandi diet which do not aggravate kapha (like khichdi, rice-sambhar, lemon juice in warm water).
4.On the day of virechana, early morning after abhyanga & Swedana, virechana yoga i.e. Trivrittavleha will be given to the patient in the dosage suitable as per his kostha.
5.After Samyaka virechana patient will have to follow samsarjana krama (specific diet schedule) for 3-7 days, depending upon shudhi prakara. )
| | 2 | Comparator Arm (Non Ayurveda) | | - | | There will be no intervention given to subjects. Only blood samples will be withdrawn for investigations |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects who are willing to sign the informed written consent.
2.Subjects of age group 18 years - 40 years irrespective of their gender, caste, or religion.
3.Snehapana arha and Virechana arha
( Subjects fit for snehana and virechana)
4.Subjects who are currently not participating in any other clinical trial or are not registered in any other research study in last 12 weeks.
5.Apparently healthy volunteers without any illness and not on any medications in the past 3 months.
|
|
| ExclusionCriteria |
| Details |
1.Pregnant women and lactating mothers.
2. Subjects having comorbodities like Hypertension, Diabetes Mellitus, Thyroid disorder, erythrocyte disorders including anaemia, sickle cell disease, hereditary membranopathies leading to altered shape, stability and function of RBCs or any other systemic illness or condition that may jeopardize the study.
3.Subjects having history of prolonged medication with corticosteroids, diuretics, anti-dyslipidaemic drugs etc or any other drugs that may influence the outcome of the study.
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
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Primary Outcome
|
| Outcome |
TimePoints |
Change in cell membrane lipidomics and membrane fluidity of human RBCs of healthy individuals.
|
To asses Membrane lipidomics and Membrane fluidity, investigations will be done at following intervals:
In Interventional Group (n=30):-
Baseline (BT) 0th Day
After Completion of Snehana (AT1)
After Completion of Svedana (AT2)-(only for n=10 subjects)
After Completion of Samsarjana Krama (AT3)
In Control Group (n=10):-
Baseline 0th Day
and On 23rd day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Improvement in quality of life (assesed by using WHOQOL-BREF scale).
2.Change in Plasma Metabolome. |
In Interventional group,
Improvement in quality of life (for n=30 subjects),Change in plasma metabolome( for n = 15 subjects) assessed in following intervals:-
Baseline (BT) 0th day
After Completion of Samsarjan Krama
In Control Group (n=10):-
Baseline 0th Day
and On 23rd day |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/06/2026 |
| 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="3"
Months="0"
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
|
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Brief Summary
|
Introduction In Ayurveda, Panchakarma (Bio Purification) is a specially designed set of five procedures of internal purification of the body through the nearest possible root. Such purification helps to expel aggravated dosha and bring back the normalcy of dosha i.e.Vata, Pitta and Kapha thus allowing the biological system to return to homeostasis , to rejuvenate and also facilitate the desired pharmaco therapeutic effects of the medicine.The elimination of aggravated dosha from the body is known as Shodhana . Virechana is one among the shodhana procedure of panchakarma done in three phases i.e. preparatory, main procedure and post procedure. Shodhananga snehapana (oral administration of medicated ghee or oil) is an essential preparatory procedure (purvakarma) before shodhana ( Bio purification) lasting for three to seven days given in arohana krama (escalating doses) until samyaka snigdha lakshanas (signs of proper internal oleation) appear. It is then succeeded by abhyanaga (oil massage ) and swedana (sudation), followed by virechana using purgative herbs to expel doshas via the rectum.Cell membrane functions are controlled by membrane fluidity, which in turn is controlled by membrane lipid composition ( Membrane lipidomics).
Need of Study Despite proven clinical efficacy of Shodhananga snehapana followed by virechana in various pathological conditions and improvement in various parameters like in lipid profile, body weight, BMI, Immunoglobulins, effect on gut microbiome, this procedure of panchakarma still has not recieved much attention with regard to its mechanism at cellular level possibly due to difficulty in conceptual compatibility. However certain animal studies have been carried out to rule out the effect of ghee intake on erythrocyte membrane dynamics of rats and effect of virechana karma on histopathological changes in section of liver, heart , kidney, spleen, jejunum , pancreas and colon of albino rats. But currently there is no study available regarding changes in cell membrane dynamics after shodhananga snehapana and virechana. Hence considering this beside the role of dietary lipids to influence membrane lipids composition which further affects membrane fluidity, this study can be done to rule out the effect of shodhananga snehapana in membrane lipidomics and fluidity thus decoding the mode of action of shodhnanaga snehapana followed by virechana in panchakarma.
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