| CTRI Number |
CTRI/2025/02/080795 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to see effect of ayurvedic formulation in management of Medovruddhi with reference to Hyperlipidemia |
|
Scientific Title of Study
|
“A Randomized Controlled Clinical Study to Evaluate The Efficacy
Of Bilwadi Kwath In management of Medovruddhi w s.r. to
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 Sweeti Bhagwat Patil |
| Designation |
MD Kayachikitsa scholar |
| Affiliation |
|
| Address |
Dr VJD Gramin Ayurved Mahavidyalaya , Patur Tal Patur Dist Akola
State Maharashtra
India
Akola
MAHARASHTRA
444501
India |
| Phone |
8080328794 |
| Fax |
|
| Email |
patilsweeti500@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashish Keche |
| Designation |
Associate Professor |
| Affiliation |
Dr VJD Gramin Ayurved Mahavidyalaya Patur Tal Patur Dist Akola Maharashtra India |
| Address |
Dr VJD Gramin Ayurved Mahavidyalaya, Patur Tal Patur Dist Akola Maharashtra India
Akola
MAHARASHTRA
444501
India |
| Phone |
8149921892 |
| Fax |
|
| Email |
rajeashish09@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashish Keche |
| Designation |
Associate Professor |
| Affiliation |
Dr VJD Gramin Ayurved Mahavidyalaya Patur Tal Patur Dist Akola Maharashtra India |
| Address |
Dr VJD Gramin Ayurved Mahavidyalaya, Patur Tal Patur Dist Akola Maharashtra India
Akola
MAHARASHTRA
444501
India |
| Phone |
8149921892 |
| Fax |
|
| Email |
rajeashish09@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Kayachikitsa Dr VJD Gramin Ayurved Mahavidyalaya, Patur Tal Patur Dist Akola Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr VJD Gramin Ayurved Mahavidyalaya PaturTal Patur Dist Akola Maharashtra India |
| Address |
Dr VJD Gramin Ayurved Mahavidyalaya, Patur Tal Patur Dist Akola |
| 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 |
| Dr Sweeti Bhagwat Patil |
Dr VJD Gramin Ayurved Mahavidyalaya Patur Tal Patur Dist Akola Maharashtra India |
Dr VJD Gramin Ayurved Mahavidyalaya Patur Tal Patur Dist Akola Maharashtra India
Akola
MAHARASHTRA |
8080328794
patilsweeti500@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, DR VJD Gramin Ayurved Mahavidhyalay, Patur, Akola |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E785||Hyperlipidemia, unspecified. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | TAB ROSUVASTATIN | ROUTE - ORALLY
DOSES - 10mg OD
KAAL - BHOJANOTTAR
ANUPAN - JAL
FOLLOW UP - EVERY 15 DAYS
DURATION - FOR 45 DAYS | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: BILWADI KWATH, Reference: SHARANGDHAR SAHITA.MADHYAMKHAND ADHYA.2-116, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: Yes(details: -MADHU), Additional Information: -FOLLOW UP EVERY 15 DAYS |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients suffering from Medovruddhijanya symptoms
2. patients serum total cholesterol Level 200-250mg/dl
3.patient having serum triglyceride Level 150-300mg/dl
4.patient having serum LDL cholesterol Level 130-160mg/dl
5.patient having serum VLDL cholesterol Level 30-4e0mg/dl
6.patient having serum HDL cholesterol Level 30-40mg/dl
|
|
| ExclusionCriteria |
| Details |
1.Age group having below 30 and above 70 years.
2.Pregnant and Lactating mother
3.Patient having Diabetes Mellitus
4.Patient having history of Heart Disease or Renal Disease
5.Patient having Acute Complication like Coronary Heart Disease ,Hepatitis
6.Patient having disorder like Carcinoma etc.anywhere in the body |
|
|
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 |
Symptom like 1.Shwasadhikya
2.Nidradhikya
3.Shrama-Asamarthata
4.Gaurava
5.Balahinata |
Symptom like 1.Shwasadhikya
2.Nidradhikya
3.Shrama-Asamarthata
4.Gaurava
5.Balahinata |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Decrease in symptoms of Medovruddhijanya symptom and
1.Serum Total Cholesterol Level 200-250mg/dl.
2.Serum Triglyceride level 150-300mg/dl
3.Serum LDL Cholesterol Level 130-200mg/dl
4.Serum VLDL Cholesterol Level 30-40mg/dl
5.Serum HDL cholesterol level 30-40mg/dl |
18 month |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
03/03/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Now-a-days, the evolution of technology has reached a point, where pretty much anything is available at the one touch. Machines and smart gadgets have replaced manual labour . People have started preferring packed & junk food to fresh, home-cooked meals. But, this Modern life-style coming at a price and a relatively crucial one as that is ‘Health’, Which causes many serious mental and physical diseases like Hyperlipidemia , Diabetes mellitus, Hypertension, Coronary heart disease etc.
The Worldwide prevalence of ‘Hyperlipidemia’ is about 39,000 per 1,00,000 patients. The matter of fear is, as per the opinion of National Commission on Macroeconomics and Health (NCMH), a Government of India undertaking, there would be around 62 million patients with CAD (Coronary Artery Disease) due to ‘Hyperlipidemia’ by 2015 in India. According to GHO (Global Health Observatory) data of WHO, globally a third of Ischemic Heart Disease is attributed to High cholesterol.
As per the scientific description, an elevated concentration of Triglycerides with Cholesterol in Fasting Plasma is called ‘Hyperlipidemia’, which causes by the accumulation of large Lipo-protein particles, contain both Triglycerides and Cholesteryl Esters. Further, which divide into Primary and Secondary types. Primary Lipid-disorders are usually inherited, whereas Secondary acquired as a result of other medical-disorders, such as Hypothyroidism, Chronic Liver Diseases, Type-II Diabetes Mellitus,Nephrotic Syndrome and reactions due to excessive intake of some drugs (for e.g. Steroids or Thiazide group drugs etc.).
Lipids and Lipo-protein abnormalities are as a modifiable risk factors for Coronary Heart Diseases because of their influence on Atherosclerosis. Under the management of Hyperlipidemia many drugs are famous in Modern medicine like Statins (Atorvastatin, Rosuvastatin etc.), Gemifibrozil, Ezetimibe, Benzafibrate etc., but adverse point of it is it develops Side effects like Dyspepsia, Headache, Myopathy, Myalgia, Abdominal pain etc. Therefore, It is a necessity to find out some human health friendly and cost-wise cheap formulations to eradicate this disease.
The basic causative factor behind Hyperlipidemia is ‘Diet’, rich in ‘Saturated Fat’ according to Modern medicine. While according to Ayurvedic terminology, food articles having properties like Madhura Rasa and Guru, Snigdha, pichchil or Abhishyandi gunas in higher percentage leads to Medovruddhi and can be correlated to hyperlipidemia.
The all above scenario encouraged us(Guide and me) to invent the new and safe Polyherbal drug ‘Bilwadi kwath’.The reason behind it is, the dravyas under this yog have ‘Tikta’ Rasas, ‘Ushna’ Viryas as well as ‘Katu’ Vipakas will definitely lead to expected Sampraptibhanga (break of pathophysiology) by their specific mode of action.
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