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CTRI Number  CTRI/2024/04/065234 [Registered on: 04/04/2024] Trial Registered Prospectively
Last Modified On: 01/04/2024
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   Study regarding the effect of ayurvedic decoction in heart disease 
Scientific Title of Study   Randomized controlled clinical study to evaluate the efficacy of Pushkarmuladi kwath as an adjuvant therapy in vataj hridrog with special reference to stable angina  
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 Ketaki Raghuveer Ramdas 
Designation  Pg scholar 
Affiliation  Ayurved Seva Sanghas Ayurved Mahavidyalaya Nashik 
Address  OPD no 14 Kayachikitsa OPD

Nashik
MAHARASHTRA
422003
India 
Phone  7057948434  
Fax    
Email  ketkiramdas@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Vd Harish Garge 
Designation  associate professor kayachikitsa department 
Affiliation  Ayurved Seva Sanghas Ayurved Mahavidyalaya Nashik 
Address  OPD no 14 Kayachikitsa OPD

Nashik
MAHARASHTRA
422003
India 
Phone  9405366160  
Fax    
Email  drhgarge@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Vd Harish Garge 
Designation  associate professor kayachikitsa department 
Affiliation  Ayurved Seva Sanghas Ayurved Mahavidyalaya Nashik 
Address  OPD no 14 Kayachikitsa OPD

Nashik
MAHARASHTRA
422003
India 
Phone  9405366160  
Fax    
Email  drhgarge@gmail.com  
 
Source of Monetary or Material Support  
Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik 
 
Primary Sponsor  
Name  Vd Ketaki Raghuveer Ramdas 
Address  Ayurved Seva Sangh Ayurved Mahavidyalaya Nashik 422003 
Type of Sponsor  Other [self] 
 
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 
Vd Ketaki Raghuveer Ramdas  Arogyashala Hospital Ayurved Seva Sangh  OPD no 14 Kayachikitsa OPD
Nashik
MAHARASHTRA 
7057948434

ketkiramdas@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe Ayurved Mahavidyalaya Nashik  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:I208||Other forms of angina pectoris. Ayurveda Condition: HRUDROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Standard Treatment protocol for stable angina 1.Tab. Aspirin 2.Tab. Clopidogrel 3. Nitrates - Glyceryl trinitrate 4.Tab. Metaprolol 5.Tab. Nicorandil 6. Tab. Atrovastatinstandard treatment of stable angina includes 1. Anti-anginal drugs - Tab. Aspirin 75 mg OD Tab. Clopidogrel 75 mg OD 2. Nitrates - Glyceryl trinitrate 0.5 mg (if there is chest pain) 3. Beta- blockers - Tab. Metaprolol 50 mg OD 4. Vasodialators - Tab. Nicorandil 5 mg 5. Statins - Tab. Atrovastatin 20 mg OD for 45 days
2Intervention ArmDrugClassical(1) Medicine Name: Pushkarmuladi kwath, Reference: charaka samhita, chikitsasthana 26/85, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: standard treatment with pushkarmuladi kwath as an adjuvant therapy
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1)Patients with signs and symptoms of Stable Angina e.g chest pain, palpitation, sweating,
fatigue,vertigo
2)Patient who met NYHA (New York Heart Association) criteria for Angina(Grade I,II and III) 
 
ExclusionCriteria 
Details  1) Patients who had previous revascularization CABG(Coronary Artery Bypass Graft), PTCA
(Percutaneous Transluminal Coronary Angioplasty) stenting.
2) Patients being evaluated for other cardiac diseases except stable angina(e.g valvular disease,
etiology of cardiomyopathy, Myocardial infraction, Evidence of heart failure)
3) Pregnant woman and lactating mother..
4) Other major co-existing illnesses like chronic anemia, malignancy, renal or hepatic disease,
stroke, auto-immune diseases.
5) Refusal to give informed consent.
6) Subjects having known chronic, contagious infectious disease, such as active tuberculosis,
Hepatitis B or C or patients taking immunosupressive drugs 
 
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 
Improvement in Stress test (trade mill test)  45 days 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in lipid profile and ECG  45 days 
 
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)   11/04/2024 
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="2"
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  
   Hridroga (Heart disease) is very common in present scenario due to the sedentary life style and increase psychosocial stress. The major causative factors i for heart problems are cigarette smoking, tobacco chewing, alcohol consumption, junk foods and obesity. According to WHO Ischemic heart disease or Coronary artery disease is the major causes of mortality. Therefore, it is needed to explore knowledge of heart disease time to time. The main purpose of this reserch is to promote the awareness about the heart disease, so prevalence of such problem can be reduced. Hridroga is among those diseases mentioned in Ayurveda where in the description is quite brief and the Ayurvedic view point needs clarification. In view of the increasing evidence of cardiac disorders in the present times this aspect assumes added importance.
   Among the five types of Hridroga described, in Vatika variety Ayurveda seems to have conceived the disease entity that comes under Angina. Stable angina is effectively managed in  modern medicine with the aim of relief in pain, normalization of ECG changes, and improvement in exercise tolerance and health related quality of life and overall survival. But still many patients are left untreated or improperly treated due to drug tolerance, serious adverse effects, un affordable cost price of the treatment and poor accessibility despite best treatment modalities available. And for a group of refractory angina patient a novel effective drug is required. Therefore, "Randomized controlled clinical study to evaluate the efficacy of Pushkarmuladi kwath as an adjuvant therapy in Vataj Hridrog with special reference to stable Angina" study was undertaken.
  In this study 60 patients will be randomly selected showing signs and symptoms of Vataj Hridrog and are randomised into 2 groups. Trial group will be treated with stanandard treatment with Pushkarmaladkwath as an adjuvant therapy while control group will be treated with standard treatment only. In clinical study patients will be examined according to subjective criteria which includes Chest pain (Hridshoola Bheda), Palpitation (Hrid dravah), Sweating, Vertigo (Moha), Fatigue (Shosha), NYHA (New York Heart Association) Score for Angina and objective criteria including ECG (Electrocardiogram) (Before and After treatinent) 2. TMT (Treadmill Machine Exercise Stress Test) (Before and After treatment) 3. Physical haemodynamic tests: (At each follow up) i. Heart Rate (HR) ii Systolic Blood Pressure (SBP) iii. Diastolic Blood Pressure (DBP) 4 Laboratory Blood Chemistry Tests as under: 1. CBC (Complete Blood Count) II. Lipid Profile before treatment and 45 days after treatment. The observations will be drawn after completion of clinical study and conclusion will be drawn accordingly. The study will be published after completion of trial.
 
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