| CTRI Number |
CTRI/2020/04/024513 [Registered on: 08/04/2020] Trial Registered Prospectively |
| Last Modified On: |
28/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Diagnostic |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study Of Paachana Modality In The Patients Of Dyslipidaemia |
|
Scientific Title of Study
|
A Study On Dashavidha Langhana In Perspective Of Autophagy To Assess The Role Of Paachana Modality To Cause Autophagy In Patients Of Medo Dushti (Dyslipidaemia) |
| Trial Acronym |
autophagy |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anita Choudhary |
| Designation |
M.D. Scholar |
| Affiliation |
All India Institute Of Ayurveda |
| Address |
Room No. 720 Department of Samhita and Siddhanta 7th Floor academic Block, All India Institute Of Ayurveda, Gautampuri, Sarita Vihar, New Delhi
New Delhi
DELHI
110076
India |
| Phone |
9460321637 |
| Fax |
|
| Email |
anitamundhan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof dr Mahesh K Vyas |
| Designation |
Professor and HOD |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room No. 716 Department of Samhita and Siddhanta 7th Floor academic Block, All India Institute Of Ayurveda, Gautampuri, Sarita Vihar, New Delhi
New Delhi
DELHI
110076
India |
| Phone |
8849802005 |
| Fax |
|
| Email |
drmaheshkvyas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Meera K Bhojani |
| Designation |
Assistant professor |
| Affiliation |
All India Institute of Ayurveda |
| Address |
Room No. 713 Department of Samhita and Siddhanta 7th Floor academic Block, All India Institute Of Ayurveda, Gautampuri, Sarita Vihar, New Delhi
New Delhi
DELHI
11076
India |
| Phone |
9990247410 |
| Fax |
|
| Email |
ayumeerabhojani@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi,110076 |
|
|
Primary Sponsor
|
| Name |
ALL INDIA INSTITUTE OF AYURVEDA |
| Address |
All India Institute Of Ayurveda, Gautampuri, Sarita Vihar, New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Prof Dr Mahesh K Vyas |
All India Institute Of Ayurveda |
OPD No. 7 & 5 All India Institute Of Ayurveda, Gautampuri, Sarita Vihar, New Delhi
New Delhi
DELHI |
8849802005
drmaheshkvyas@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| THE INSTITUTIONAL ETHICS COMMITTEE OF ALL INDIA INSTITUTE OF AYURVEDA, NEW DELHI |
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 |
musta churna |
Oral Administration Of 3gm twice daily empty stomach |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Total Cholesterol (201-300 mg/dl)
Serum TGLs (161mg/dl or more)
Serum HDL (below 40mg/dl)
Serum LDL (131mg/dl or more)
Serum VLDL (41mg/dl or more) |
|
| ExclusionCriteria |
| Details |
Patients Who Are Under Conventional Medications.
Subjects With Diabetes.
Patients With Grave Disease,
Psychological Disorders.
Patients With Hypothyroidism And Other Metabolic Disorders.
Patients With Cardio Vascular Diseases Like Hypertension And Other Severe Conditions. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total Cholesterol Less Then 200mg/dl Along With The Assessment Of Samyaka Of Lakshana Of Langhana |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Improve The Quality Of Life |
60 days |
|
|
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 1 |
|
Date of First Enrollment (India)
|
15/04/2020 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Amongst the Shat Upakarma as explained by Acharya Charaka one is Langhana therapy. Here the word Langhana means Laghu that is the whole procedure of producing lightness in the body at various level like Dosha, Dhatu, Mala or even at Manas i.e. at psychological level. 10 types of Langhana are described by Acharya Charaka in Sutrasthana, one among them is Pachana or it can be understood as Shamana rupi langhana. It is the treatment principle which is adopted for the digestion of Ama Sansrishtha conditions at various entities i.e. Koshtha, Dosha, Dhatu etc. Furthermore, Autophagy is a normal physiological process in the body that deals with destruction of cells within the body. It maintains homeostasis or normal functioning by protein or Fat degradation. Autophagy mainly maintains a balance between manufacture of cellular components and break down of damaged or unnecessary organelles and other cellular constituents. Autophagy also removes and clears damaged cell organelles. It is the natural, regulated mechanism of the cell that disassembles unnecessary or dysfunctional components. In and all it allows the orderly degradation and recycling of cellular components.4 This mechanism of autophagy can be understood more likely be the same what Pachana Karma performs in our body. Thus, Autophagy may be correlated with Pachana Karma. Pachana karma is indicated in Madhyam Bala Rogas i.e. the diseases with moderate strength or when Doshas are moderately vitiated, or in case of Kapha Pitta Samuttha Vyadhis, and hence, it can be used in Medo Dushti janita Vyadhis viz. Dyslipidaemia. Dyslipidaemia is a disorder of lipoprotein metabolism, which can include overproduction or deficiency of lipoproteins or both. The disorder can manifest as an elevation of plasma cholesterol, triglycerides, or both, or a low high-density lipoprotein level or all three together that contributes to the development of atherosclerosis. World Health Organization (WHO) in 2002 reported that high cholesterol level is one of the main non-communicable disease related risk factor in India. The Indian Council of Medical Research (ICMR) surveillance project reported a prevalence of Dyslipidaemia of 37.5% among adults, with an even higher prevalence of dyslipidaemia (62%) among young male industrial workers. In Dyslipidaemia, there exists the condition of Ama and in Ayurveda the best line of treatment indicated for Ama is Langhana Karma one if its modality is Pachana Karma where we facilitate the digestion of undigested matter and thus this disease can be overcome by the process of Autophagy that may be considered to be generated through Paachana Karma. |