| CTRI Number |
CTRI/2024/04/065907 [Registered on: 18/04/2024] Trial Registered Prospectively |
| Last Modified On: |
27/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Other (Specify) [Therapeutic] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of cardiotonic medicine in improvement of cardiac physiology |
|
Scientific Title of Study
|
A Conceptual and applied study on physiology of Hridaya in Ayurveda perspective w.s.r to the effect of Hridya Aushadha on Hrit Kriya (Cardiac Physiology) |
| 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 Maharshi Joshi |
| Designation |
MD scholar |
| Affiliation |
Institute of Teaching and Research in Ayurveda |
| Address |
6th floor department of kriya Sharira institute of teaching and research in ayurveda opposite to B division police station gurudwara road Jamanagar Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
9429108974 |
| Fax |
|
| Email |
maharshijoshi98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Hitesh AVyas |
| Designation |
Professor |
| Affiliation |
Institute of Teaching and Research in Ayurveda |
| Address |
Room No- 304 Department of Basic Principle Institute of Teaching and research in Ayurveda opposite B Division police station Gurudwara road Jamnagar Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
9426433231 |
| Fax |
|
| Email |
vdhavyas@itra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati Khandale |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Teaching and Research in Ayurveda |
| Address |
6th floor department of kriya Sharira institute of teaching and research in ayurveda opposite to B division police station gurudwara road Jamanagar Gujarat
Jamnagar
GUJARAT
361008
India |
| Phone |
9850483223 |
| Fax |
|
| Email |
khandale_swati@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Institute of Teaching and Research in Ayurveda |
|
|
Primary Sponsor
|
| Name |
Institute of Teaching and Research in Ayurveda Jamnagar |
| Address |
Institute of Teaching and Research in Ayurveda opposite B division police station gurudwara road Jamnagar 361008 Gujarat |
| 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 Maharshi Joshi |
Institute of Teaching and Research in Ayurveda Hospital |
OPD no-18 OPD of Kriya Sharira Institute of Teaching and Research in Ayurveda Jamnagar
Jamnagar
GUJARAT |
9429108974
maharshijoshi98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe of Institute of Teaching and Research in Ayurveda Jamnagar Gujarat |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Human Volunteers |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Arjuna Ksheer Paka, Reference: Bhavprakash Nighantu Vatadi Varga verse no 23,24, Dravya Guna Vigyan Utarardh - By Yadavji Trikamji, Route: Oral, Dosage Form: Ksheerpaka, Dose: 40(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vrikshamla Panaka, Reference: Charak Samhita Sutra Sthan Adhyaya 4 Shada Virechana Shatashriya Verse no 10,Bhav Prakash Nighnatu Aamradi Phala Varga verse no -121,122, Dravya Guna vigyana Utarardh By shree Yadavji Trikamji , Route: Oral, Dosage Form: Panak/ Sharbat, Dose: 100(ml), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 45 Days, anupAna/sahapAna: No, Additional Information: Vrikshamla is a drug that is used routinely as a part of food also in Charaka samhita it is mentioned Agrya Dravya Amla Hridayanam |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Participants having age between 25-50 years of irrespective of genders
Participants willing to give their consent to participate in study. |
|
| ExclusionCriteria |
| Details |
Participants having Bradycardia or Tachycardia also suffering from uncontrolled hypertension Diabetes obesity and any major other cardiac disease and cardiac abnormalities which needs emergency intervention congenital and anatomical abnormalities in heart participants not willing to participants in study abnormalities found in ECG |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe the improvement in functions of Hridaya like Heart rate, Blood Pressure and Heart rhythm and as well as noted improvement in recovery time(the time when vital become normal) after treatment of 45 days in participants |
During the intervention period at 45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Explanation & understanding the conceptual study on physiology of Hridaya with ayurveda perspective & asses the improvement in Hrit Kriya with help of Hridya Aushadha |
45 Days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/05/2024 |
| Date of Study Completion (India) |
01/09/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
01/09/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
INTRODUCTION- Hridaya is considered as a vital organ in body. Hridaya (Heart) plays an important role in maintaining physical as well as mental wellbeing of an individual. in contemporary science the functions of Hridaya is limited up to circulation and supply of nutrients around the body, but in Ayurveda Hridaya is not merely limited up to circulation it is considered as Pranayatam, Manas Sthan, and Para Ojas Sthan. Hridaya is Mula of Pranavaha Strotas and Rasavaha Strotas. Hridaya is one of the Tri marmas .also it is considered as Sadya Pranahara Marma,Vyan Vayu, Sadhaka Pitta, and Avalambak Kapha all resides in Hridaya. Hridaya is included in Dasa Pranayatanam in Ayurveda. this particular work has been planned to explore the physiological importance of Hridaya with Ayurveda view point. Acharya Charaka mentioned in Hridya Mahakashayam as Hridya Aushadha Vrikshamla. in Bhav Prakash Nighantu it is said to be Hridroga Hara. it is Hridya in nature due to its Amla Rasa. RATIONALITY FOR SELECTION OF TOPIC- Several Hridya Aushadhis have been described in diffrent ayurvedic Samhita e.g. in Charak Samhita (Hridya Mahakashaya) in Sushrut Samhita (Brhutyadi Gana, Parushakadi Gana) in Ashtang Hridayam ( Vidaryadi Gana) as preventive and curative aspects of Hridroga. It is necessary to know the physiology of Hridaya, without which treatment could not be planned effectively,hence this study has been planned. AIM- To explore and explain the physiological importance of Hridaya with Ayurveda perspective. To evaluate the effect of Vrikshamla (Hridya Aushadhi) in improvement of physiological function of Hridaya. OBJECTIVES- To collect and analyzes the refereances regarding Hridaya and its function from various ayurvedic texts.To explain physiological importance of Hridaya with Ayurveda view point. MATERIALS AND METHODS- Total 30 participants of fullfilling selection criteria and age group between 25 to 50 years taken in double group. Vrikshamla Panaka given to Participants Pratah and Sayam (ananna). to rule out the pathology investigations like blood, Lipid profile,and Serum Creatinine will be done before as well as after treatment only once. RESULTS AND DISCUSSION- Data generated during the above study will be present in systemic manner as shall be analyzed stastically. where the important points of the conceptual study, Analytical study, pharmacological study will be discussed. SIDE EFFECTS- This drug has no known unwanted effects. Adverse Drug Reactions if any observed will be reported to pharmacovigilance cell of ITRA jamnagar. |