| CTRI Number |
CTRI/2024/05/067526 [Registered on: 17/05/2024] Trial Registered Prospectively |
| Last Modified On: |
06/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study management of chaturjatak vati in hyperlipidemia |
|
Scientific Title of Study
|
A single arm clinical study to evaluate the efficacy of chaturjataka vati in the management of hyperlipidemia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Amey Rajendra Ekhande |
| Designation |
MD Scholar Kayachikitsa |
| Affiliation |
Dr. D. Y. Patil college of Ayurveda and Research center |
| Address |
Dr D Y Patil college of ayurveda and research centre, Sant Tukaram nagar, pimpri, pune
Pune
MAHARASHTRA
411018 India
Pune
MAHARASHTRA
411018
India |
| Phone |
8275057627 |
| Fax |
|
| Email |
drameyekhande1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gunvant Yeola |
| Designation |
Head of department of kayachikitsa |
| Affiliation |
Dr. D. Y. Patil college of Ayurveda and Research center |
| Address |
Dr D Y Patil college of ayurveda and research centre, Sant Tukaram nagar, pimpri, pune
Pune
MAHARASHTRA
411018 India
Pune
MAHARASHTRA
411018
India |
| Phone |
9028321955 |
| Fax |
|
| Email |
Gunvantayurved@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gunvant Yeola |
| Designation |
Head of department of kayachikitsa |
| Affiliation |
Dr. D. Y. Patil college of Ayurveda and Research center |
| Address |
Dr D Y Patil college of ayurveda and research centre, Sant Tukaram nagar, pimpri, pune
Pune
MAHARASHTRA
411018 India
MAHARASHTRA
411018
India |
| Phone |
9028321955 |
| Fax |
|
| Email |
Gunvantayurved@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.D.Y.Patil College of Ayurveda and Research centre Sant tukaram nagar, pimpri, pune |
|
|
Primary Sponsor
|
| Name |
Dr. Amey Rajendra Ekhande |
| Address |
Dr.D.Y.Patil College of Ayurveda and Research centre Sant tukaram nagar, pimpri, pune |
| Type of Sponsor |
Other [Self] |
|
|
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 Amey Rajendra Ekhande |
Dr.D.Y.Patil College of Ayurveda and Research centre |
OPD no. 5 (kayachikitsa) ground floor Dr D Y Patil college of ayurved and research centre pimpri pune 411018 Pune Maharashtra
Pune
MAHARASHTRA |
8275057627
drameyekhande1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. DYPCA and RC Institutional ethic committee pimpri pune - 18 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E785||Hyperlipidemia, unspecified. Ayurveda Condition: MEDOVRUDDHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Chaturjataka vati, Reference: Bhavprakash Karpuradi varga 72,73, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Ushnodaka), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1) Age limit from 30 to 70 yrs.
2) Newly detected Hyperlipidemic or known case of Hyperlipidemic patients. |
|
| ExclusionCriteria |
| Details |
1) Pregnant women & lactating mothers.
2) Patient with severe renal, hepatic, coronary heart diseases. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To reduce LDL, Total cholesterol, Triglycerides and Increase HDL levels |
60 days study. 20th, 40th, 60th follow up days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To study present day food habits and lifestyle as a causative factor for Hyperlipidemia.
2) To study the concept and role of Agnideepana and Amapachana in the management of
hyperlipidemia. |
60 days study. 20th, 40th, 60th follow up days |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
27/05/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
01/09/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
To study the efficacy of Chaturjataka vati in the management of hyperlipidaemia. Total 35 patients will be enrolled. Two tablets of 500 mg will be administered twice a day before food along with the lukewarm water for duration of 60 days and follow up will be done on 20th 40th 60th day and final conclusion will be drawn on the basis of statistical methods. |