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CTRI Number  CTRI/2024/06/069286 [Registered on: 20/06/2024] Trial Registered Prospectively
Last Modified On: 23/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Role of Trivruttadi churna and Hingwadi churna in Heart disease 
Scientific Title of Study   A randomized comparative clinical Study to evaluate the efficacy of Trivruttadi churna and Hingwadi churna in the management of Kaphaja Hridroga with special reference to Chronic Stable Angina Pectoris 
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 Litty Mathew 
Designation  PG Scholar 
Affiliation  National Instituteof Ayurveda, Jaipur 
Address  Department of Kayachikitsa, National Institute of Ayurveda, Deemed to be University, Jorawar Singh Gate, Amer Road, Jaipur.

Jaipur
RAJASTHAN
302002
India 
Phone  9995960482  
Fax    
Email  littymathew211@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Professor Udai Raj Saroj 
Designation  Professor 
Affiliation  National Institute of Ayurveda, Jaipur 
Address  Department of Kayachikitsa, National Institute of Ayurveda, Deemed to be University, Jorawar Singh Gate, Amer road, Jaipur.

Jaipur
RAJASTHAN
302002
India 
Phone  9983341119  
Fax    
Email  ursarojayu@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Professor Udai Raj Saroj 
Designation  Professor 
Affiliation  National Institute of Ayurveda, Jaipur 
Address  Department of Kayachikitsa, National Institute of Ayurveda, Deemed to be University, Jorawar Singh Gate, Amer Road, Jaipur.

Jaipur
RAJASTHAN
302002
India 
Phone  9983341119  
Fax    
Email  ursarojayu@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Ayurveda Jorawar Singh Gate, Amer Road Jaipur, Rajasthan, India-302002 
 
Primary Sponsor  
Name  National Institute of Ayurveda Jaipur 
Address  National Institute of Ayurveda, Jorawar Singh Gate, Amer Road, Jaipur, Rajasthan, 302002 
Type of Sponsor  Research institution and hospital 
 
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 Litty Mathew  National Institute of Ayurveda, Jaipur  OPD No. 1, Department of Kayachikitsa, National Institute of Ayurveda, Jorawar Singh Gate, Amer Road, Jaipur, Rajasthan, 302002
Jaipur
RAJASTHAN 
9995960482

littymathew211@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, National Institute of Ayurveda  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:I209||Angina pectoris, unspecified. Ayurveda Condition: KAPAJAHRUDROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Hingwadi Churna, Reference: Charaka Samhita Sidhisthana 9 th chapter 19 th sloka, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -), Additional Information: Anupana is lukewarm water
2Comparator ArmDrugClassical(1) Medicine Name: Trivruttadi Churna, Reference: Brihat Nighantu Ratnakara- Hridroga, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -), Additional Information: Anupana is lukewarm water
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  Patients with evidence of chronic stable angina pectoris including cases with controlled hypertension and controlled type 2 diabetes mellitus without complications and not on insulin. Any patient on conventional treatment for at least one month and having symptoms of chronic stable angina pectoris.  
 
ExclusionCriteria 
Details  Patients with the history of unstable angina pectoris, acute myocardial infarction, severe valvular defects, congenital heart disease, pericarditis, arrhythmia, congestive heart failure. Patients with the history of extra cardiac ailments like renal failure, uncontrolled hypertension, uncontrolled type 2 diabetes mellitus with or without complications, type 1 diabetes mellitus. Patients with ejection fraction less than 40%. Chronic alcoholics, pregnant and lactating mothers.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes present in the CTMT of registered patients with symptoms of chronic stable angina pectoris.  At baseline and at the end of 60 days of treatment. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Changes present in the ECG and 2D echocardiography of registered patients with symptoms of chronic stable angina pectoris.2. Changes present in the symptoms of Kaphaja Hridroga and chronic stable angina pectoris.  At baseline and at the end of 60 days of treatment. 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 2 
Date of First Enrollment (India)   01/10/2024 
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
Modification(s)  

       Coronary artery disease occurs when heart’s blood supply is blocked or interrupted by building up of atheroma in the coronary arteries. They become narrow and blood supply to the heart muscle is restricted. This can cause angina. If coronary artery becomes completely blocked it can cause heart attack. This is a medical emergency. Angina occurs when heart muscles need more blood than it is getting such as during physical activity or during strong emotions. Angina is not a disease but a symptom and warning sign of heart disease. A patient with angina may complain of episodes of chest discomfort, usually described as heaviness, pressure, squeezing, smothering, or choking and only rarely as frank pain. Angina is considered to be ‘chronic’ and ‘stable’ when symptoms are present for at least two months, without changes in severity, character or triggering circumstances. Chronic stable angina has a consistent duration and severity and is provoked by a predictable level of exertion. It can also be provoked by emotional stress. An imbalance between myocardial oxygen supply and metabolic oxygen demand causes the symptoms of angina pectoris and represents a major therapeutic target.                  

       In Ayurveda Literature, the heart is the root of the rasavaha srotas and vitiation of rasa dhatu by morbid dosha leads to heart disease. The etiological factors which lead to vitiation of this srotas include- Aharaja- Guru, Sheeta, Atisnigdham, Atimatram, Samashanam. Vagbhata has mentioned that the dietary habits samashana, vishamashana and adhyashana cause serious fatal diseases including the hridroga. Due to the Agnimandhya, the presence of Ama renders the body metabolically slow and sluggish along with varying degree of blockage of the channels of the body at different levels from gross to molecular level. During its sojourn in these channels, it tends to adhere to the walls thereby narrowing the passages or causes srotorodha. Increased impermeability and sluggishness of the body channels or rasavaha srotas increases resistance and compel to pump blood more vigorously and the burden on the heart.  There are 5 types of Hridroga namely Vataja hridroga, Pittaja hridroga, Kaphaja hridroga, Tridoshaja hridroga and Krimija hridroga. The etiopathogenesis of chronic angina pectoris has in order resembled any existing Kaphaja Hridroga entity in particular.

NEED OF STUDY

         Despite important advancements in the pharmacotherapy of Chronic Stable Angina Pectoris, the actual percent reduction in mortality associated with the use of modern pharmacological agents has been relatively unpretentious. Moreover, the available pharmacological agents are also not free from various adverse effects. Hence there is an immense requirement of certain Ayurvedic drugs which can increase efficiency and performance of compromised heart for healthy living in a natural way with least possible adverse effects.

 

 

 
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