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CTRI Number  CTRI/2024/07/070691 [Registered on: 16/07/2024] Trial Registered Prospectively
Last Modified On: 13/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical Trial to study the effect of Vatsakadi Vati in management of dyslipdemia  
Scientific Title of Study   A randomized controlled clinical study to see the efficacy of Vatsakadi Vati in management of Medodushti with special reference to Dyslipidemia.  
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 Ajay Bhavsing Marmat 
Designation  PG scholar 
Affiliation  R.A.Podar Ayurvedic college 
Address  OPD no. 18/19, Kayachikitsa Department,R.A.Podar Ayurvedic college, Dr. Annie Besant road, worli, Mumbai

Mumbai
MAHARASHTRA
400018
India 
Phone  8788947698  
Fax    
Email  ajaybhmarmat@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Geeta Parulkar 
Designation  HOD and Professor(Kayachikitsa),R.A.Podar medical college(Govt),worli,Mumbai-18 
Affiliation  R.A.Podar Ayurvedic college 
Address  OPD no.18/19 Kayachiktsa Department,R.A.Podar Ayurvedic college, Dr. Annie Besant road, worli, Mumbai-18.

Mumbai
MAHARASHTRA
400018
India 
Phone  8087101471  
Fax    
Email  geeta.parulkar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Geeta Parulkar 
Designation  HOD and Professor(Kayachikitsa),R.A.Podar medical college(Govt),worli,Mumbai-18 
Affiliation  R.A.Podar Ayurvedic college 
Address  OPD no.18/19 Kayachikitsa Department,R.A.Podar Ayurvedic college, Dr. Annie Besant road, worli, Mumbai

Mumbai
MAHARASHTRA
400018
India 
Phone  8087101471  
Fax    
Email  geeta.parulkar@gmail.com  
 
Source of Monetary or Material Support  
M.A.Podar Ayurvedic Hospital, Dr. Annie Besant road, Worli,Mumbai-400018,Maharashtra,India. 
 
Primary Sponsor  
Name  RAPodar Ayurvedic college 
Address  OPD no.18/19 R.A.Podar Ayurvedic college, Dr. Annie Besant road, worli, Mumbai 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ajay Bhavsing Marmat  M.A.Podar Ayurvedic Hospital  OPD-18/19, Kayachikitsa department, Dr. Annie Besant road, worli, Mumbai 400018
Mumbai
MAHARASHTRA 
8788947698

ajaybhmarmat@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BORS committee of institution, R.A.Podar medical college (AYU)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E785||Hyperlipidemia, unspecified. Ayurveda Condition: MEDOVAHASROTODUSHTIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-tab atorvastatintablet atorvastatin 10mg will be given to group B at night once a day for 8 weeks
2Intervention ArmDrugOther than Classical(1) Medicine Name: Vatsakadi vati, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: warm water), Additional Information: It contains vatsak(Holarrhoea antidycenterica), Maricha (Piper nigrum), Guggulu (commiphora mukul)
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1)Both Genders.
2) Age group having 30 to 70 years age.
3)Obese Dyslipidemic and Non-Obese Dyslipidemic Patients (BMI-18.50 to 40.00 kg/m2 as per New
Updated WHO classification of BMI of 2004).
4)Patient having Serum Total Cholesterol Level ≥200mg/dl
5)Patient having Serum LDL Cholesterol Level ≥130mg/dl
6)Patient having serum VLDL Cholesterol Level ≥40 mg/dl
7)Patient having Serum HDL Cholesterol Level ≤40mg/dl
8)Patient having Serum Triglyceride Level ≥150mg/dl  
 
ExclusionCriteria 
Details  1)Pregnant and lactating mothers.
2)Patients having Diabetes Mellitus.
3)Patients having history of Respiratory Diseases Complications, Coronary Heart Diseases, Renal
Diseases etc.
4)Patients having Acute Complications like Severe Hypertension (B.P 150/90 mm Hg in those with
age 60 and older, and 140/90 mm Hg for adults less than 60 yrs. according to Eighth Joint
National Committee Guideline), Hepatitis or with history of major surgery etc.
5)Patients having disorders like Carcinoma anywhere in the body etc.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To assess the effect of "vatsakadi vati" on lipid levels in medodushti w.s.r. to dyslipidaemia  8 weeks
 
 
Secondary Outcome  
Outcome  TimePoints 
To observe the effect on following Parameters
lipid profile
1.Total Cholesterol
2.VLDL
3.HDL
4.SR.TRIGLYSERIDES
5.LDL 
EVERY MONTHLY FOR 3 MONTHS 
 
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   Phase 3 
Date of First Enrollment (India)   23/08/2024 
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="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  
Dyslipidemia is a disorder of lipoprotein metabolism which includes abnormality in any or all the lipoprotein in blood. It may be manifested by elevation of the Total Serum Cholesterol, Low Density Lipoproteins (LDL) concentration, Triglyceride Cholesterol concentration and decreased in High Density Lipoproteins (HDL) Cholesterol concentration in blood. Cardiovascular diseases is a leading cause of mortality in many economically developed nations accounting near about 30% of all deaths. The co-existence of Hypertension and Dyslipidemia has adverse impact on vascular endothelium, which results in enhanced Atherogenesis leading to Cardiovascular and Cerebrovascular diseases. 

The scattered references available in Ayurveda correlating Dyslipidemia, with Medodhatu. Abnormal composition of Medodhatu is considered as Medodushti Above described etiological factors influences and disturb the Jatharagni primarily and consequently Bhutagni and Dhatvagni, which results in ’Agnimandya’. It further disturbs the production of seven elements of body which we called as Saptadhatus. Hence, derangement of Jatharagni in general and Medodhatvagni in particular leads to excessive formation of Saam or Apachit Medodahtu, which finally results in Medodushti (Dyslipidemia). lipids can be correlated

Prevalence of Dyslipidemia according to NCEP (National Cholestrol Education Programme) is ver high with 79% of subjects having at least one lipid abnormality. Recent studies reported that high Cholesterol is present in 25-30 % in Urban & 15-20% in Rural population. The most common Dyslipidemia in India are borderline high LDL Cholesterol, Low HDL Cholesterol and Triglycerides. Studies have reported that over 20 years of period, Total Cholesterol, LDL Cholesterol ant Triglycerides have increased among Urban population. 

The contents of Vatsak-Marich-Guggulu are Vatsak (Holarrhena Antidysenterica) and Marich(Piper nigrum) (clerodendron Serratum) and (Purana and Shuddha) Guggulu (Commiphora mukul ). The first two Dravyas are from vatsakadi gana (9)described in "Ashtangsangraha’s Vividhaganasagraha Adhyaya under Sutrasthan. Katu ras of vatsak, Marich and (Purana and Shuddha) Guggulu will increase the qualities of Kleda-Shoshana and Lekhana by the help of their particular characteristics. Additionally, Tikta Rasa of all the said contents also can help to achieve Kledaharana, Medoshoshana, Deepana-Pachana. 

Predominant Katu Vipaka of vatsak, Marich and (Purana and Shuddha) Guggulu will play a role to reduce vitiated Kapha in the mentioned disease by the action of "Laghu Guna’. The most important feature of this Guggulu Kalpa is ’Rasayana quality so as to gain the resistance power against this Vyadhi by maintaining equilibrium of Tridoshas in the body as per ’Rasayana Principle’. The most precious quality of Guggulu is that, it is a ’Shreshtha’ (Predominant) Dravya among Meda-Vatahara Dravyas, It also acts as Tridoshahara 

After observation of previous research on all above said properties of this Vatsak-Marich- Guggulu Vati, we can say that it will definitely lead to expected Sampraptibhanga (breaking of Pathophysiology) in Medodushti (Dyslipidemia).
During study, vatsakadi vati will be given to trial group (30 patients)  and tab atorvastatin 10mg will be given to control group (30 patients) for 8 weeks

Investigation to be done-
1)Blood- CBC,ESR,Liver Function and Renal Function Tests before treatment as routine and to exclude complications said in ’Exclusion Criteria’.
2)Blood Sugar (Fasting and Post-Prandial) before treatment as routine and to avoid Diabetes Mellitus.
3)Lipid Profile before and after treatment (i.e. to be repeated after 4th and 8th week).
4)X-Ray (Chest) PA view before treatment as routine to avoid Respiratory disease complications.
5)ECG before treatment as routine to avoid Cardiac Diseases complications.
 
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