| CTRI Number |
CTRI/2023/11/059428 [Registered on: 02/11/2023] Trial Registered Prospectively |
| Last Modified On: |
27/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic clinical trial on high cholesterol |
|
Scientific Title of Study
|
An open clinical trial to evaluate the efficacy of
Vatsakadi Vati in 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 |
Vd Vaishali Shamrao Meshram |
| Designation |
Associate Professor |
| Affiliation |
R.A.Podar Medical College, Worli, Mumbai-18 |
| Address |
2nd floor, Department of Kayachikitsa, Jupiter Ayurved Medical College and Tarini Hospital,Shankarpur,Nagpur
Mumbai
MAHARASHTRA
441108
India |
| Phone |
9403109360 |
| Fax |
|
| Email |
vaishalimeshram30@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vd Geeta D Parulkar |
| Designation |
Professor, HOD |
| Affiliation |
R.A.Podar Medical College, Worli, Mumbai-18 |
| Address |
1st floor, Department of Kayachikitsa, R.A.Podar Medical College, Worli, Mumbai
Mumbai
MAHARASHTRA
400018
India |
| Phone |
8652694332 |
| Fax |
|
| Email |
geeta.parulkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vd Vaishali Shamrao Meshram |
| Designation |
Associate Professor |
| Affiliation |
R.A.Podar Medical College, Worli, Mumbai-18 |
| Address |
2nd floor, Department of Kayachikitsa, Jupiter Ayurved Medical College and Tarini Hospital,Shankarpur,Nagpur
Mumbai
MAHARASHTRA
441108
India |
| Phone |
9403109360 |
| Fax |
|
| Email |
vaishalimeshram30@gmail.com |
|
|
Source of Monetary or Material Support
|
| R.A.Podar Medical College, Worli,Mumbai-18
|
|
|
Primary Sponsor
|
| Name |
Vd Vaishali Shamrao Meshram |
| Address |
Jupiter Ayurved Medical College and Tarini Hospital Shankarpur Nagpur 441108 |
| 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 Vaishali Shamrao Meshram |
R.A.Podar medical college, Mumbai |
1st floor, Department of Kayachikitsa, R.A.Podar medical college, Worli Mumbai 400018
Mumbai
MAHARASHTRA |
9403109360
vaishalimeshram30@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| R A Podar medical college worli mumbai |
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: Vatsakadi vati, Reference: Asthanga Sangraha, Sutrasthana 16/27-28, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Koshana Jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient irrespective of age, sex, religion etc.of Hyperlipidemia.
2.Patients with high blood lipid profile.Lipid profile showing any one or more of the following criteria was considered diagnostic of hyperlipidemia.
3.Patients with controlled Type 2 diabetes mellitus and hypertensive patients with blood pressure within the normal limits.
4.Obese Hyperlipidemic and Non-Obese hyperlipidemic Patients (BMI-18.50 to 40.00 kg/m2 as per New Updated WHO classification of BMI of 2004).
5.Patient having Serum Total Cholesterol Level >200mg/dl.
6.Patient having Serum LDL Cholesterol Level >130mg/dl
7.Patient having serum VLDL Cholesterol Level >40mg/dl.
8.Patient having Serum HDL Cholesterol Level<40mg/dl.
9.Patient having Serum Triglyceride Level >150mg/dl.
|
|
| ExclusionCriteria |
| Details |
1.Patients having a history of untreated thyroid disorder.
2.Pregnant women & lactating mother.
3.Chronic illness and infection like TB, CA and HIV infection.
4.Patient is suffering with psychological disorders like anxiety, depression.
5.Patient with Respiratory Diseases Complications, Coronary Heart Disease, Hepatic or Renal Disease etc.
6.Drug induced Hyperlipidemia.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Study to determine the effectiveness of Vatsakadi Vati in the dose of 500mg twice a day to maintain normal lipid profile level.
|
30th day,60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study in detail about Medovriddhi according to Ayurvedic classics.
2.To study in detail about Hyperlipidemia according to modern medicine.
|
30th day, 60th day |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 3 |
|
Date of First Enrollment (India)
|
21/11/2023 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
The aim of study is to
evaluate the clinical efficacy of Vatsakadi Vati with koshna jala in management
of Hyperlipidemia (Medovriddhi). To study the details of Vatsakadi Vati.To study in detail
about Medovriddhi according to Ayurvedic classics. To study in detail about Hyperlipidaemia according to modern medicine. The trial will be conducted
on 50 patients showing anyone or more parameters of lipid profile i.e.,
serum Cholesterol, serum Triglycerides, serum HDL, serum LDL, and serum VLDL, the range for the lipid profile will be decided
as per the American Journal of Lifestyle Medicine. Lipid profile will be
checked on the day patient enrollment. Medicine will be given for 60 days, at
the interval of 30 days patients will be assess the effect of therapy on
objective parameters. After 60 days of trial collected data of objective
parameters will be statistically assess and conclusion will be drawn.
|