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CTRI Number  CTRI/2025/04/084599 [Registered on: 11/04/2025] Trial Registered Prospectively
Last Modified On: 07/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Diagnostic
Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Ayurvedic Management of Dyslipidemia Through Virechan Karma And Shaman Snehpana 
Scientific Title of Study   A Clinico Comparative Study Of Shamana Snehpana With Triphaladi Taila and Virechana Karma In The Management Of Dyslipidemia 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Swetlana Upreti 
Designation  Pg Scholar 
Affiliation  Government Akhand Anand Ayurved College 
Address  OPD 5,panchkarma department goverment akhand anand ayurved college, bhadra Ahmadabad 380001 India

Ahmadabad
GUJARAT
380001
India 
Phone  8979269473  
Fax    
Email  swatiupreti7@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrKrupali Raut 
Designation  Reader 
Affiliation  Government Akhandanand Ayurved College 
Address  OPD 5, panchkarma department goverment akhandanand ayurved college, bhadra,ahmedabad Ahmadabad 38OOO1 Gujrat India

Ahmadabad
GUJARAT
380001
India 
Phone  8849830133  
Fax    
Email  rautkajal77@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrKrupali Raut 
Designation  Reader 
Affiliation  Government Akhandanand Ayurved College 
Address  OPD 5, panchkarma department government akhandanad ayurved college, bhadra, ahmedabad Ahmedabad 38OOO1 Gujrat India

Ahmadabad
GUJARAT
380001
India 
Phone  8849830133  
Fax    
Email  rautkajal77@gmail.com  
 
Source of Monetary or Material Support  
Government Akhand Anand Ayurvedic College, opd no 5,Panchkarma Department,Bhadra Ahmedabad 38OOO1 Gujrat India  
 
Primary Sponsor  
Name  Government Akhand Anand Ayurved College 
Address  OPD 5, Panchkarma Department Government Akand Anand Ayurved College, Bhadra, Ahmadabad Gujrat 380001 India 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Swetlana Upreti  Government Akhandanand Ayurved College  OPD 5 Panchkarma Department Government Akhandanand Ayurved College Bhadra Ahemdabad 38OOO1 Gujrat INDIA
Ahmadabad
GUJARAT 
8979269473

swatiupreti7@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Comittee Government Akhand anand ayurved college  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E785||Hyperlipidemia, unspecified. Ayurveda Condition: MEDOROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Triphaladi taila, Reference: Bhav Prakash Madhyam Khand 39/16, Route: Oral, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 28 Days, anupAna/sahapAna: Yes(details: Mudga yusha), Additional Information: -
2Comparator ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Charak sutra 23/8, Procedure details: Deepan pachan with Trikatu churna for 3-5 days(2-3gms bd as per Atura agni) Snehpana with Til taila for 3-7days Abhyang (with nirgundi taila) & swedan (baspa sweda)for 3 days. Virechan karma with Abhayadimodak (8-10 tablets as per atur koshtha) According to shuddhi Samsarjan Krama)
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Age between 18 to 6O years
2 Patients having
Total Cholestrol more than 2OOmgdl OR
LDL more than 1OO mgdl OR
Triglycerides more than 15O mgdl OR
HDL less than 4O mgdl OR
Apolipoprotein B more than 12O mgdl
3 Snehpana yogya
4 Virechan yogya 
 
ExclusionCriteria 
Details  1 Age below 18 and more than 6O years
2 Patients with uncontrolled HTN and DM
3 Pregnant and lactating women
4 Virechan Ayogya
5 Snehpana Agyogya
6 Known case of heart disease Stroke liver disease COPD
7 Acute or chronic infectious diseases like TB STDs
AIDS
8 On medications like corticosteroids, hormonal therapy antidepressants  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Outcome will be based on LIPID PROFILE OR Apolipoprotein B before and after treatment that is will be based on objective criterion
Patients having
Total Cholestrol more than
2OOmgdl OR
LDL more than 1OO mgdl OR
Triglycerides more than 15O
mgdl OR
HDL less than 4O mgdl OR
Apolipoprotein B more than 12O mgdl








Total Cholestrol
LDL
Triglycerides
HDL
Apolipoprotein B 
1 month 
 
Secondary Outcome  
Outcome  TimePoints 
Patients will be assessed by blood investigations cbc, urine routine and microscopic.  1 month 
 
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   Phase 2/ Phase 3 
Date of First Enrollment (India)   25/04/2025 
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="0"
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  
Research question
Whether Shaman Snehpana and Virechana Karma are equally effective or not in the management of Dyslipidemia?

Hypothesis

NULL HYPOTHESIS [HO]There is no significant difference in the effect between Shamana Snehapana and Virechan karma in the Management of dyslipidemia

Alternative Hypothesis
(H1) Shamana Snehapana is more effective than Virechana Karma in the management of dyslipidemia
(H2) Virechana Karma is more effective than Shamana Snehapana in the management of dyslipidemia

AIM:
To evaluate and compare the efficacy of Shamana Snehapana and Virechana Karma in the management of Dyslipidemia
 

OBJECTIVES
 To study the complete etiopathology, symptomatology and progress of Dyslipidemia According to Ayurveda as well as modern science

 To study the efficacy of Shamana Snehapana in the management of dyslipidemia
 To study the efficacy of Virechan in the management of dyslipidemia
To study Virechan karma according to all Ayurvedic texts

OBJECTIVE CRITERIA
LIPID PROFILE 
TOTAL CHOLESTEROL  more than 200 mgdL
LDL more than100 mgdl
TRIGLYCERIDES  more than150 mgdL
HDL less than 40 mgdL
 APOLIPOPROTEIN B  more than 120mgdL

SUBJECTIVE CRITERIA
There are no signs and symptoms of dyslipidemia

Inclusion criteria
1Age between 18 to 60 yrs
2 On the basis of National Cholesterol Education Program (NCEP) Adult Treatment Plan(ATP) III
Guidelines  patients  having
 TOTAL CHOLESTEROL  more than 200 mgdL
OR
 LDL  more than 100 mgdL
OR
TRIGLYCERIDES  more than 150 mgDl
OR
 HDL less than 40 mgDl
OR
 APOLIPOPROTEIN B more than 120mgdL
 Patients who are Snehapana Yogya
Patients who are Virechana Yogya

Exclusion criteria
 Age below 18 years and more than 60 years
 Patients with uncontrolled HTN uncontrolled DM
 Pregnant / lactating women
 Virechan Ayogya
 Snehpana Ayogya
 Heart Diseases, Kidney Diseases  Stroke  Liver Disease
 Pulmonary Dysfunction or COPD
Patients with a history of any acute or chronic infectious diseases like TB AIDS and Other STDs
Patients taking medications like corticosteroids hormonal therapy
antidepressants or any other drugs which may affect the outcome of the
study

Investigations

Following investigations will be carried out before and after treatment

 LIPID PROFILE
APOLIPOPROTEIN B
To rule out other pathologies CBC and Urine (R and M) will be done

Study Design

Study type:      Intervention
Purpose:          Treatment
Masking:         Open labelled. no masking
Study design: Randomized clinical trial
Allocation:      Computer generated randomization
Timing:            Prospective
 End point:      Efficacy and safety
No. of Groups: 2
Sample size:  30 patients (15 patients in each group)

Details of interventions

GROUPING: Selected patients will be divided randomly into two group

GROUP A
15 patients will be treated with Shamana Snehapana 

 GROUP B
15 patients will be treated with Virechana Karma

GROUP A: SHAMAN SNEHAPANA WITH TRIPHALADI TAIL
 DRUG DOSE & ANUPANA  ADMINISTRATION
TIME
DURATION 
 Triphala
Trikatu and
Saindhava
Siddha Taila
 30-50ml

With Mudga Yusha
 Annakala Prakankshit 28 Days


GROUP B: VIRECHANA KARMA

Procedure is divided into 3 parts as follows


PURVAKARMA
  PROCEDURE DRUG AND DOSE  DURATION
  Deepana and Pachana Drug Trikatu Churna
 Dose    4 to 6 gm per day (2
to 3gm twice a day per Aatura
Agni)
Time of
Administration   Before
Food
 Anupana   Ushna Jala
 Route       Oral Route

3 to 5 Days (Till the
Karma appearance of
Samyak Deepana
and Pachana
Lakshana observed)
 Snehapana Drug    Tila taila 3 to 7 Days

 Dose    20 to 40 ml starting dose in vardhamana Krama
 (as per Aatura-Kostha and Agni)


Time of Administration  
EarlyMorning at empty
stomach


Anupana  Ushna Jala
Route    Oral Route
Diet       Light Diet (drava ushna
annabhishyan  natisnidgha  asankirn
a)
3 to 7 Days 
 Sarvanga Abhyanga and baspa sweden 

 
Drug  Tila taila QS
(Approx 50 ml)
 For 1st  2nd  3rd day during
vishrama kala after
completionof abhyantar
snehapana and also 4th day
prior to Virechan karma
 4days



PRADHAN KARMA

  PROCEDURE DRUG AND DOSE  DURATION 
 Virechan karma Drug   Abhyadimodak
8-10 Tab
 
Anupana Sheet Jala

 Time of Administration Sheleshma Kale Gate after 10am
 1 DAY


 PASCHAT KARMA
 PROCEDURE DRUG AND DOSE  DURATION 
 Samsarjana
Krama
  Diet Plan will be fixed as per
shuddhi for 3 to 7 days
The regimen of 7  5  3 days
will be fixed according to the Pravar Madhyama  Avara Shuddhi

The sequence of Peya  Vilepi
AkritMudga   Yusha andOdana
Krita Mudga  Yusha andOdana
will be
served for 3 2 1 aaharakala
According to the type of
shuddhi

 3 to 7 Days



 
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