| CTRI Number |
CTRI/2023/03/050406 [Registered on: 06/03/2023] Trial Registered Prospectively |
| Last Modified On: |
24/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurvedic trial for treatment of Dyslipidemia |
|
Scientific Title of Study
|
A Randomized Control Trial to Evaluate the Efficacy of Shamana Snehapana with
Virechana Karma in 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 Pooja |
| Designation |
PG Scholar |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Room no.123, PG Department of Panchakarma,
Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar
South West
DELHI
110073
India |
| Phone |
8586889537 |
| Fax |
|
| Email |
poojadagar016@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ProfDr Arun Gupta |
| Designation |
Head of Department |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Room no.142, PG Department of Panchakarma,
Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar
South West
DELHI
110073
India |
| Phone |
08178361290 |
| Fax |
|
| Email |
arun24@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
ProfDr Arun Gupta |
| Designation |
Head of Department |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
Room no.142, PG Department of Panchakarma,
Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar
South West
DELHI
110073
India |
| Phone |
08178361290 |
| Fax |
|
| Email |
arun24@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Chaudhary Brahm Prakash Ayurved Charak Sansthan |
|
|
Primary Sponsor
|
| Name |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
PG Department of Panchakarma, Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, New Delhi |
| 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 Pooja |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
OPD and IPD of PG Department of Panchakarma, Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar, New Delhi-110073
South West
DELHI |
8586889537
poojadagar016@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-CBPACS |
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 | Comparator Arm | Procedure | - | virecana-karma, विरेचन-करà¥à¤® | (Procedure Reference: Charak, Procedure details: Deepana and Pachana with Chitrakadi vati 2 tablet twice a day after taking meal with lukewarm water for 3 days
Snehapana with MAHATRIPHALADYA GHRITA
as per koshta and agni (in morning with empty stomach) for 3-7 days
Abhyanga & Swedana Abhyanga with Tiltaila (35 min)and Sarvanga sweda (10-15 min) 3 days
Pradhana Karma
Virechaka Yoga- Trivritta Avleha as per kostha and agni
Sansarjana Krama Diet as per Shudddhi(from the evening of virechana day) 3-7 days
)
| | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Mahatriphaladhya Ghrita, Reference: Ashtang hridyam , Route: Oral, Dosage Form: Ghrita, Dose: 20(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 14 Days, anupAna/sahapAna: Yes(details: -Lukewarm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.On the basis of National Cholesterol Education Program (NCEP) Adult Treatment Plan (ATP) III Guidelines patient having-
LDL>100mg/dl
or
Total cholesterol> 200mg/dl
or Triglycerides> 150mg/dl
2.Patients fit for Virechana Karma
|
|
| ExclusionCriteria |
| Details |
1.Co-morbidity associated with dyslipidemia.
2.Patient having uncontrolled Diabetes Mellitus i.e., HbA1c>10%
3. Pregnant / lactating woman.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Shamana snehapana may shows better result by balancing the lipid profile in comparison to Virechana karma in management of dyslipidemia
|
4 weeks 4 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
0 |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
Final Enrollment numbers achieved (Total)= "52"
Final Enrollment numbers achieved (India)="52" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/03/2023 |
| Date of Study Completion (India) |
15/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The study is to compare the Efficacy of Shaman Snehapana with Virechana Karma in management of Dyslipidemia. In one group Mahatriphladhya Ghrita as Shamana Snehapana in the dose of 20ml in morning(empty stomach) were given in two sittings (day 1-7) & (day 11-17) with gap of 3 days (day 8-10). In another group Virechana Karma were conducted. The trial were conducted in Ch. Brahm Prakash Ayurved Charak Sansthan with outcome Shamana Snehapana may shows better result than Virechana Karma in management of Dyslipidemia. Outcome of the study- Virechana Karma was found better treatment than Shamana Snehapana in reducing serum cholesterol, serum Triglycerides, serum LDL and serum VLDL. Both groups were shows insignificant result in increasing Serum HDL level. The Virechana Karma is a better treatment option in the management of Dyslipidemia as compared to Shamana Snehapana. Although Shamana Snehapana is also effective in the management of Dyslipidemia. |