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CTRI Number  CTRI/2024/07/071319 [Registered on: 25/07/2024] Trial Registered Prospectively
Last Modified On: 15/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A Comparative clinical study of three different ayurvedic formulations along with medicated purgation in Hyperlipidaemia  
Scientific Title of Study   A Clinical study to evaluate and compare the effect of Guduchyadi yoga and Vachadi yoga with Trayushnadi loha along with virechana in Medoroga with special reference to Hyperlipidaemia. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrAshwini Patange 
Designation  PhD Scholar 
Affiliation  Shri DGM Ayurvedic Medical College Gadag 
Address  Department of kayachikitsa Ground Floor Room number 3 Shri DGM Ayurvedic Medical College and Hospital Gadag

Gadag
KARNATAKA
582103
India 
Phone  9986842245  
Fax    
Email  ashwinipatange248@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrAshwini Patange 
Designation  PhD Scholar 
Affiliation  Shri DGM Ayurvedic Medical College Gadag 
Address  Department of Kayachikitsa Ground Floor Room number 3 Shri DGM Ayurvedic Medical College and Hospital Gadag

Gadag
KARNATAKA
582103
India 
Phone  9986842245  
Fax    
Email  ashwinipatange248@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Santosh N Belavadi 
Designation  Principal HOD PhD Guide 
Affiliation  Shri DGM Ayurvedic Medical College, Gadag 
Address  Department of Kayachikitsa Ground Floor Room number 3 Shri DGM Ayurvedic Medical College and Hospital Gadag

Gadag
KARNATAKA
582103
India 
Phone  9886916367  
Fax    
Email  hardikasnb@gmail.com  
 
Source of Monetary or Material Support  
Department of Kayachikitsa Shri DGM Ayurvedic Medical college and Hospital Gadag Karnataka India PIN 582103 
 
Primary Sponsor  
Name  Dr Ashwini Patange 
Address  Department of Kayachikitsa Ground Floor Room number 3 Shri DGM Ayurvedic Medical College and Hospital Gadag Karnataka India PIN 582103 
Type of Sponsor  Other [Dr. Ashwini Patange] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Ashwini Patange  S V P Rural Ayurvedic Medical College and Hospital Badami  Department of Kayachikitsa Room number 2 S V P Rural Ayurvedic Medical College and Hospital Badami PIN 587201
Bagalkot
KARNATAKA 		 9986842245

ashwinipatange248@gmail.com 
Dr Santosh N Belavadi  Shri DGM Ayurvedic Medical College and Hospital Gadag  Department of Kayachikitsa Ground Floor Room number 3 Shri DGM Ayurvedic Medical College and Hospital Gadag Karnataka India PIN 582103
Gadag
KARNATAKA 		 9886916367

hardikasnb@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Shri DGM Ayurvedic Medical College and Hospital Gadag  Approved 
Shri Veerapulikeshi rural ayurvedic medical coolege and hopital.Badami,Dist.Bagalkot  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E784||Other hyperlipidemia. Ayurveda Condition: MEDOROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Sushruta chikitsa sthana 33, Procedure details: Poorvakarma- Deepana-pachana with Panchakola churna, Snehapana with Murchita tila taila,Abhyanga with Murchita tila taila and sweda Paschat karma- Samsarjana krama with peyadi krama)
(1) Medicine Name: Guduchyadi yoga, Reference: Yogaratnakar, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 2(g), Frequency: bd, Duration: 60 Days
2Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Sushruta chikitsa sthana 33, Procedure details: Poorva karma- Deepana-pachana with Panchakola churna, Snehapana with Murchita tila taila, Abhyanga with Murchita tila taila and sweda, Pradhana karma- Virechana with Icchabhedi rasa 125mg Paschat Karma- Samsarjana karma with peyadi krama)
(1) Medicine Name: Vachadi yoga, Reference: Astanga Hridaya, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 2(g), Frequency: bd, Duration: 60 Days
3Comparator ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Sushruta chikitsa sthana 33, Procedure details: Poorvakarma- Deepana-Pachana with Panchakola churna, Snehapana with Murchita tila taila and sweda, Pradhana karma- Virechana karma with Icchabhedi rasa 125mg, Paschat karma- Samsarjana karma with Peyadi krama )
(1) Medicine Name: Trayushnadi loha, Reference: Yogaratnakar, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 2(g), Frequency: bd, Duration: 60 Days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Patient suffering from Medoroga lakshanas like Kshudraswasa, Nidradhikya, Alpabala, Atisweda, Dourgandhya along with increase level of lipid profile.i.e.Serum total cholesterol level 200mg/dl and above,Serum triglyceride level 150mg/dl and above,Serum HDL level 40mg/dl and below,Serum LDL level 130mg/dl and above,Serum VLDL level 30mg/dl and above

2)Who is fit for ruksha virechana.
3)Age between 20 to 60 years of age group of either sex.
 
 
ExclusionCriteria 
Details  1)Patient having Hypertension, Diabetes Mellitus, cardiovascular disease, renal disease, acute infective hepatitis, alcoholic hepatitis or cerebral disease.
2)Pregnant and Lactating mother.
3)Patient having disorders like carcinoma anywhere in the body.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To know the effects of intervention on Total cholesterol,serum triglyceride,serum HDL,serum LDL,serum VLDL.  base line-40th day-80th day-108 th day 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate if the hyperlipidemia condition is reversible through virechana and shamana oushadhi.
to standardize the safe and effective ayurvedic line of managment in hyprelipidemia in comparison to established drug in contemporary medicine.
 		 16 weeks 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
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)   12/08/2024 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 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  

 

      Elevated levels of blood lipids are well documented risk factors for cardiovascular disease and stroke in developed and developing countries. Hyperlipidaemia is second only to hypertension in the list of the 10 most common chronic conditions that were seen. Globally a third of ischemic heart disease is attributed to high cholesterol is estimated to cause 2.6 million deaths.Hyperlipidaemia refers to elevated cholesterol, elevated triglycerides or both. Hyperlipidaemia is a defect often in lipid metabolism or transport. The risk factors commonly observed are unhealthy lifestyles in population such as alcohol consumption, smoking, poor diet and physical inactivity. WHO prevalence of hyperlipidaemia recent studies shows 28.5 million people get affected per year. In India approximately 25-30 % of urban and 15-20 % of rural subjects are suffering hyperlipidaemia.
      Medoroga is generally used term for the disorder related to Medodhatu dusthi. Medodusthi is abnormal deposition of Medodhatu in body due to disturbance in metabolism and agnimandya.Medoroga is caused due to unbalanced diet and sedentary habits. As dietary factor includes overeating, frequent eating, excessive madhura, sheeta, guru ahara, atimadypana, behavioural factors like lack of exercise, sleeping in daytime etc. Genetic factors or hereditary factors having significant role in development of Medoroga.
     Medodhatu dusthi leads to complex consequential process of Medovruddhi. Medodusthi may happen due to excessive production of Medodhatu (due to dietary, behavioural, Genetic or hereditary factor). This increased Medodhatu causes margavarodha and depletion of other dhatu and aggrevation of vata. This aggravated vata increase false appetite, which leads to over consumption of food and excessive medodhatu production which is sent for circulation. This particular stage is correlated with hyperlipidaemia which has increased circulated lipids in the blood .The lakshanas of medodusthi are Kshudraswasa,Atinidra,Alpabala,Atisweda, Dourgandhya.
     After considering nidana, samprapti, lakshana the medications which are having ushna, teekshna, ruksha, laghu guna along with deepana, pachana, kaphahara, medohara and lekhana property will be considered in the treatment.—So in this study  Panchakola churna , Trayushanadya loha ,Guduchyadi gana ,Vachadi gana .
    The drugs selected above will be helpful in avoiding further complications due to hyperlipidaemia. Hence study is entitled as “A clinical study to evaluate and compare the effect of Guduchyadi yoga and Vachadi yoga  with Trayushanadi loha along with  virechana in Medoroga with special reference to Hyperlipidaemia.”
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