| CTRI Number |
CTRI/2021/04/032552 [Registered on: 06/04/2021] Trial Registered Prospectively |
| Last Modified On: |
05/04/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
TO ASSESS EFFICACY OF ERANDA KSHAR YOGA AND TRYUSHNADI GUGGULU IN THE MANAGEMENT OF MEDOROGA W.S.R. TO DYSLIPIDEMIA |
|
Scientific Title of Study
|
A COMPARATIVE STUDY ON THE EFFECT OF ERANDA KSHAR YOGA AND TRYUSHNADI GUGGULU IN THE MANAGEMENT OF MEDOROGA W.S.R. TO 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 Sujata Yadav |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
Department of kayachikitsa , AYURVEDIC AND UNANI TIBBIA COLLEGE AND HOSPITAL
Central
DELHI
110005
India |
| Phone |
9354925030 |
| Fax |
|
| Email |
sujatakcdelhi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujata Yadav |
| Designation |
HOD & Associate Professor |
| Affiliation |
Ayurvedic & Unani Tibbia College Karol Bagh New Delhi -110005 |
| Address |
ROOM NO. 6 ,Department of kayachikitsa , AYURVEDIC AND UNANI TIBBIA COLLEGE AND HOSPITAL
Central
DELHI
110005
India |
| Phone |
9354925030 |
| Fax |
|
| Email |
Sujatakcdelhi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSujata Yadav |
| Designation |
HOD & Associate Professor |
| Affiliation |
Ayurvedic & Unani Tibbia College Karol Bagh New Delhi -110005 |
| Address |
ROOM NO. 6 ,Department of kayachikitsa , AYURVEDIC AND UNANI TIBBIA COLLEGE AND HOSPITAL
DELHI
110005
India |
| Phone |
9354925030 |
| Fax |
|
| Email |
Sujatakcdelhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| AYURVEDIC & UNANI TIBBIA COLLEGE & HOSPITAL,Karol Bagh, New Delhi -110005 |
|
|
Primary Sponsor
|
| Name |
Ayurvedic and Unani Tibbia College and Hospital |
| Address |
DEPARTMENT OF KAYACHIKITSA , AYURVEDIC & UNANI TIBBIA COLLEGE & HOSPITAL, KAROL BAGH ,NEW DELHI 110005 |
| 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 PANKAJ BHARDWAJ |
AYURVEDA AND UNANI TIBBIA COLLEGE AND HOSPITAL |
AYURVEDA AND UNANI TIBBIA COLLEGE AND HOSPITAL,KAROL BAGH NEW DELHI -110005
Central
DELHI |
7428505270
rambhardwaj707@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition:E785||Hyperlipidemia, unspecified. Ayurveda Condition: Medoroga, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group B -Eranda kshar yoga |
eranda kshar 250 mg + hingu churna 250 mg as prakshep with manda |
| Intervention |
Group A - Tryushnadi guggulu |
500 mg BD orally with lukewarm water |
| Intervention |
Group C |
Tryushnadi guggulu 500 mg bd orally with lukewarm water + Eranda kshar yoga [ eranda kshar 250 mg + hingu churna 250 mg as prakshep with manda |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a) Patients between the age group of 18-60 years of either sex.
b) Willing and able to participate in the study for 90 days.
c) Patients having Serum Cholesterol 201-400mg/dl, Serum Triglycerides 151- 400 mg/dl LDL Cholesterol 131-250 mg/dl, HDL Cholesterol <40mg/dl.
d)Patients with strictly controlled Diabetes Mellitus (HbA1c less than or equal to 7%)
|
|
| ExclusionCriteria |
| Details |
Patients having medical history of-
a) Patients who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial Infarction, congestive heart failure, Stroke or severe Arrhythmia, Unstable angina in the last six months.
b) Patients on prolonged (>6weeks) medication with corticosteroids, antidepressants, anticholinergics, immunosuppressant, estrogen replacement therapy etc. or any other drugs that may have an influence on the outcome of the study and patients on oral contraceptives.
c) Patients with poorly controlled hypertension (systolic >140 and diastolic >90 mm of Hg) despite of antihypertensive agents.
d) Patients with evidence of malignancy.
e) Hypersensitivity to any of the trial drugs or their ingredients.
f) Patients who have completed participation in any other clinical trial drugs or their ingredients in one -month period.
g) Patients who have received any cholesterol lowering medication (allopathic drug) within last two weeks.
h) Pregnancy and Lactating mother.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the clinical efficacy of Tryushnadi Guggulu and Eranda kshar yoga in management of dyslipidemia. |
3 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the safety of Tryushnadi Guggulu and Eranda kshar yoga in management of dyslipidemia. |
90 Days |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
06/04/2021 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Outcome will be published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Number of dyslipidemia patients are increasing in societies on an
alarming rate. Dyslipidemia
is highly prevalent and is closely related to coronary heart disease which is the most common
cause of death. So a search for holistic and alternative intervention for treating early dyslipidemia is necessary which might not have side effects. This trial tries to search these quests. |