| CTRI Number |
CTRI/2021/07/034572 [Registered on: 05/07/2021] Trial Registered Prospectively |
| Last Modified On: |
04/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study to Evaluate The Effect of Draksha (Vitis Vinifera Lin) Panak in Dyslipidaemia. |
|
Scientific Title of Study
|
Open Labelled Clinical study to Evaluate the Effect of Draksha (Vitis Vinifera Lin) Panak in Dyslipidaemia. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vd Nikhita Nalawade Khabale Patil |
| Designation |
M.D. Scholar Swasthvritta |
| Affiliation |
Sumatibhai Shah Ayurveda Mahavidyalaya |
| Address |
OPD No. 4, Department of Swasthvritta, Sane Guruji Arogya Kendra, Malvadi, Hadapsar. department of Swasthvritta, MAMs Sumatibhai Shah Ayurveda Mahavidyalaya, Hadapsar, Pune.
Pune
MAHARASHTRA
411028
India |
| Phone |
7875874580 |
| Fax |
|
| Email |
nikitakhabalepatil@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Ujwale |
| Designation |
HOD Department of Swasthvritta & Yoga |
| Affiliation |
Sumatibhai Shah Ayurveda Mahavidyalaya |
| Address |
OPD No. 4, Department of Swasthvritta, Sane Guruji Arogya Kendra, Malvadi, Hadapsar. Department of Swasthvritta, MAMs Sumatibhai Shah Ayurveda Mahavidyalaya, Hadapsar, Pune.
Pune
MAHARASHTRA
411028
India |
| Phone |
9922008027 |
| Fax |
|
| Email |
ujwale_rs@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ramesh Ujwale |
| Designation |
HOD Department of Swasthvritta & Yoga |
| Affiliation |
Sumatibhai Shah Ayurveda Mahavidyalaya |
| Address |
OPD No. 4, Department of Swasthvritta, Sane Guruji Arogya Kendra, Malvadi, Hadapsar. Department of Swasthvritta, MAMs Sumatibhai Shah Ayurveda Mahavidyalaya, Hadapsar, Pune.
Pune
MAHARASHTRA
411028
India |
| Phone |
9922008027 |
| Fax |
|
| Email |
ujwale_rs@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Swasthvritta and Yoga, Sane Guruji Arogya Kendra, Malvadi, Hadapsar, Pune. |
|
|
Primary Sponsor
|
| Name |
Sane Guruji Arogya Kendra |
| Address |
Sane Guruji Arogya Kendra, Malvadi, Hadapsar, Pune |
| 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 |
| Vd Nikhita Nalawade Khabale Patil |
Sane Guruji Arogya Kendra, Malvadi, Hadapsar |
OPD No 4, Department of Swasthvritta and Yoga, Sane Guruji Arogya Kendra, Malvadi, Hadapasar,
Pune
MAHARASHTRA |
7875874580
nikitakhabalepatil@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E784||Other hyperlipidemia. Ayurveda Condition: hrudya , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Draksha Panak with Pathya ahara. |
It is a Formulation of Ayurvedic herbs prepared in the form of Panak for oral administration having combination of Draksha(vitis vinifera),water,khandasharkara along with prakshep of Ela churna. this formulation will be administered in the dosage of 160 ml OD and Pathya ahara for 60 days. |
| Comparator Agent |
Pathya ahara |
Pathya ahara is adviced to the patients to follow for 60 days. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient of age group 20 to 50 years,irrespective of their gender, religion.
2.Patients with abnormal Sr. lipid levels are singly, or in the cluster of two or all three.
3.Irrespective of taking lipid lowering drug therapy.
4.Irrespective of family hidtory of Atherosclerotic Cardiovascular Disease (ASCVD), Dyslipidaemia.
5.Patient irrespective of known case of HTN. |
|
| ExclusionCriteria |
| Details |
1.Patient with Mrudu koshta.
2.Patient known case of Diabetes Mellitus.
3.pregnant Woman.
4.Patient with known case of Atherosclerotic Cardiovascular Disease/ ischemic heart disease.
5.Patient with operated for heart blockages like PTCA or Bypass surgery.
6. Patient with known congenital heart disease. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| A clinical study to evaluate efficacy of Draksha (vitis vinifera Lin.) Panak in Dyslipidaemia. Parameter of efficacy will be Blood Lipid Profile Reports before and after treatment. |
The drug will be given for 60 days. Patient will be assessed on 25th day, 30th day, 45th day and 60th day of the treatment.Total duration of the study will be 2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| A clinical study to evaluate efficacy of Draksha (vitis vinifera Lin.) Panak in Dyslipidaemia. Parameter of efficacy will be Blood Lipid Profile Reports before and after treatment. therefore secondary outcome will relief in sign and symptoms of dyslipidaemia |
The drug will be given for 60 days. Patient will be assessed on 25th day, 30th day, 45th day and 60th day of the treatment.Total duration of the study will be 2 months |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
05/07/2021 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is open labelled Randomized comparative clinical trial to evaluate the effect of Draksha (vitis vinifera Lin.) Panak for 60 days with Pathya ahara in patients with Dyslipidaemia. The Primary outcome will be on Blood Lipid levels in patients with Dyslipidaemia. |