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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:E785||Hyperlipidemia, unspecified. Ayurveda Condition: MEDOROGAH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Drug | Classical | | (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: - | 2 | Comparator Arm | Procedure | - | 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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