| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I209||Angina pectoris, unspecified. Ayurveda Condition: KAPAJAHRUDROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (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 | | 2 | Comparator Arm | Drug | Classical | | (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 |
|
|
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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.
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
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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. |