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CTRI Number  CTRI/2025/07/090306 [Registered on: 07/07/2025] Trial Registered Prospectively
Last Modified On: 04/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Single Arm Study 
Public Title of Study   Coronary Artery Disease 
Scientific Title of Study   An open labelled observational clinical trial to evaluate the combined effect of virechanottara bilwadhi kashaya basti in hrudroga wsr to coranary artery disease  
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 Patil Sushma Balaji 
Designation  panchakarma Post Graduate Scholar 
Affiliation  Taranath Government Ayurveda Medical college and hospital 
Address  Department of PG studies in Panchakarma Taranath govt ayuerveda medical collage and hospital dr rajkumar road ballari karnataka

Bellary
KARNATAKA
583101
India 
Phone  9108297495  
Fax    
Email  sushmabalajipatil99@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Doddabasayya kendadamath 
Designation  Proffesor 
Affiliation  Taranath Government Ayurveda Medical college and hospital 
Address  Department of PG studies in Panchakarma Taranath govt ayuerveda medical collage and hospital dr rajkumar road ballari karnataka

Bellary
KARNATAKA
583101
India 
Phone  9986916015  
Fax    
Email  drkendadamath@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Patil Sushma Balaj 
Designation  Panchakarma Post Graduate Scholar 
Affiliation  Taranath Government Ayurveda Medical college and hospital 
Address  Department of PG studies in Panchakarma Taranath govt ayuerveda medical collage and hospital dr rajkumar road ballari Karnataka

Bellary
KARNATAKA
583101
India 
Phone  9108297495  
Fax    
Email  sushmabalajipatil99@gmail.com  
 
Source of Monetary or Material Support  
Department of PG studies in panchakarma,Room no 6,Taranath Government Ayurvedic Medical college and Hospital ,Dr Rajkumar road Ballary -583101 
 
Primary Sponsor  
Name  Pandit Taranath Government Ayurveda Medical college and hospital ballari 
Address  Pandit Taranath Government Ayurveda Medical college and hospital ballari,Dr Rajkumar road - 583101 karnataka 
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 Patil Sushma Balaj  Taranath Government Ayurveda Medical college,Ballary  Department of PG Studies in Panchakarma ,Room no 6 ,Taranath govt ayurveda medical collage and hospital dr rajkumar road ballari-583101,karnataka.India
Bellary
KARNATAKA 
09108297495

sushmabalajipatil99@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Taranath Government Ayurveda Medical College Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:I700||Atherosclerosis of aorta. Ayurveda Condition: HRUDROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients of angiographically documented Stable Coronary Artery Disease on treatment
Patients with ejection fraction more than 25%
Patients of either sex between the age group of 30 to 70 years
Patients with Hyperlipidemia and Dyslipidemia
Patients with signs and symptoms of Hrudroga
Patients who are fit for Snehapana, Virechana and Basti
 
 
ExclusionCriteria 
Details  • Patients who don’t provide written informed consent.
Patients of Congestive Cardiac Failure
Patients of Acute Myocardial Ischemia
Patients with uncontrolled Hypertension and Diabetes
Pregnant and Lactating women
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Improvement in ejection fraction and signs and symptoms of CAD  Improvement in ejection fraction and signs and symptoms of CAD 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   15/07/2025 
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="0"
Months="1"
Days="23" 
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  

·      

Coronary heart disease is a type of heart disease where the arteries of the heart cannot deliver enough oxygen-rich blood to the heart. This is due to the buildup of cholesterol and other material, on their inner walls called atherosclerosis. As a result, the heart muscle can’t get the blood or oxygen it needs. This can lead to chest pain (angina) or a heart attack1.

Coronary artery disease is the foremost single cause of mortality and loss of Disability Adjusted Life Years (DALYs) globally. In 2015 CAD accounted for 8.9 million deaths and 164.0 million DALYs2. In India in 2016, CVDs contributed to 28.1% of total deaths and14.1% of total disability-adjusted life years3.

Hrudroga is explained in various Ayurvedic texts. It occurs due to Pranavaha – Rasavaha srotodushti. The causative factor can be understood as agnimandya (poor metabolism) leading to ama which causes rasa dushti and that may lead to upalepatva (coating), sanga (obstruction) in rasavaha srotas (vessels) which hampers vyana vayu leading to Hrudroga4

     Modern interventions for CAD include stenting and bypass surgery which are time taking, invasive and expensive. Ayurvedic line of management for Hrudroga include vamana5, virechana6 and basti7 etc. The treatments such as virechana and basti are the major shodhana procedures which cleanse the body by removing the ama (toxins) thereby clearing the margavarodha (obstruction) which helps in the treatment of disease condition.             

So, in the present study Virechana followed by Bilwadi Kashaya Basti7 is undertaken. For Deepana-Pachana, Trikatu churna8 is advised and for Snehapana Bilwadi taila is used followed by Abhyanga with Murchitatila taila and Bashpa sweda. Danti haritaki9 is taken for Virechana. It is sukha virechaka and niratyaya mentioned by Acharya Charaka. As Hrudaya is one of the sadyapranahara marma10. Acharya Charaka has mentioned basti for marma paripalana11. Bilwadi kashaya basti helps to regulate the movement of vata dosha, strengthens and nourishes the cardiac muscle. To put forward effective strategies for management and treatment of CAD through ayurvedic treatment this study is undertaken.

Hence the present study entitled as “AN OPEN LABELLED OBSERVATIONAL CLINICAL TRIAL TO EVALUATE THE COMBINED EFFECT OF VIRECHANOTTARA BILWADI KASHAYA BASTI IN HRUDROGA W.S.R TO CORONARY ARTERY DISEASE "undertaken.

OBJECTIVES OF THE STUDY:

·       Clinical evaluation of the combined effect of Virechanottara Bilwadi Kashaya Basti in Hrudroga w.s.r to Coronary Artery Disease.

Ø ASSESSMENT CRITERIA:

 

        SUBJECTIVE PARAMETERS:

 

1.     Hrutshoola ( Angina )

2.     Swasavarodha(Dyspnea)

3.     Hrudrava(Palpitation)

4.     Klama ( Fatigue)

5.     Sweda (Sweating) 


       1.     Hrutshoola (Angina)

Canadian Cardiovascular Society grading of angina pectoris 

Grade I

Ordinary physical activity does not cause angina, such as walking and climbing stairs.  Angina with strenuous or rapid or prolonged exertion at work or recreation

Grade II

Slight limitation of ordinary activity.  Walking or climbing stairs rapidly, walking uphill, walking or stair climbing after meals, or in cold, or in wind, or under emotional stress, or only during the few hours after awakening.  Walking more than two blocks on the level and climbing more than one flight of ordinary stairs at a normal pace and in normal conditions

Grade III

Marked limitation of ordinary physical activity.  Walking one or two blocks on the level and climbing one flight of stairs in normal conditions and at normal pace

Grade IV

Inability to carry on any physical activity without discomfort, anginal syndrome may be present at rest

 

According to New York Heart Association     

1.     Swasavarodha (Dyspnea)     

 

NYHA CLASS OF DYSPNEA

DEFINATION

Grade I

Ordinary physical activity does not cause undue dyspnea.

Grade II

Ordinary physical activity causes dyspnea.

Grade III

Comfortable at rest; less than ordinary physical activity causes dyspnea.

Grade IV

Symptoms occur at rest; any physical activity increases discomfort.

 

Hrudrava  (Palpitation)

NYHA CLASS OF PALPITATION

DEFINATION

Grade I

Ordinary physical activity does not cause undue palpitations.

Grade II

Ordinary physical activity causes palpitations.

Grade III

Comfortable at rest; less than ordinary physical activity causes palpitations.

Grade IV

Symptoms occur at rest; any physical activity increases discomfort.


Klama ( Fatigue)

 

NYHA CLASS OF FATIGUE

DEFINATION

Grade I

Ordinary physical activity does not cause undue fatigue.

Grade II

Ordinary physical activity causes fatigue.

Grade III

Comfortable at rest; less than ordinary physical activity causes fatigue.

Grade IV

Symptoms occur at rest; any physical activity increases discomfort.

Sweda (Sweating)

 

SWEATING CLASS

DESCRIPTION

Grade I

No sweating present, even during physical activity or stress

Grade II

Occasional sweating, typically during intense physical activity or under significant stress

Grade III

Frequent sweating occuring during moderate physical activity or stressful situations.

Grade IV

Profuse sweating occuring even at rest or with minimal physical activity, often accompanied by other symptoms such as shortness of breath or chest discomfort


OBJECTIVE PARAMETERS:

1.     Lipid profile

Total serum cholesterol

Normal - < 200mg/dl

Borderline high – 200-239mg/dl

High - >240mg/dl

Low density lipoprotein

Normal -100-130mg/dl

Mild -130-159mg/dl

Moderate-160-189mg/dl

Severe - > 189mg/dl

Triglycerides

Normal < 150mg/dl

Mild – 150- 499mg/dl

Moderate- 500-886mg/dl

Severe > 886mg/dl

                                                                                     

High density lipoprotein

Low range -< 40mg/dl

High protective range > 60mg/dl

                                       

              Ejection Fraction

             The simplest classification as per the American College Of Cardiology (ACC) that is used clinically as follows:

Hyper dynamic      

LVEF greater than 70%

Normal   

LVEF 50% to 70%

Mild dysfunction                    

LVEF 40% to 49%

Moderate dysfunction             

LVEF 30% to 39%

 Severe dysfunction                   

LVEF less than 30%

 

 

                        Blood pressure:   Recommended by American Heart Association

 

Blood pressure category

Systolic mm hg

Diastolic mm hg

Normal

Less than 120

Less than 80

Elevated

120 - 129

Less than 80

High blood pressure (Hypertension) stage 1

130 - 139

80 - 89

High blood pressure (Hypertension) stage 2

140 or higher

90 or higher

Hypertension crisis

Higher than 180

Higher than 120

                                           
       Ø  OVERALL ASSESSMENT:

·       Marked relief-above 75% improvement.

·       Moderate relief-50%-75% improvement.

·       Good relief -25% -50% improvement.

·        Mild relief - below 25% improvement.

·       No relief – 0%

                                     

Ø  OVERALL ASSESSMENT:

·       Marked relief-above 75% improvement.

·       Moderate relief-50%-75% improvement.

·       Good relief -25% -50% improvement.

·        Mild relief - below 25% improvement.

·       No relief – 0%

 
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