| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:I208||Other forms of angina pectoris. Ayurveda Condition: HRUDROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator 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. Atrovastatin | standard 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 | | 2 | Intervention Arm | Drug | Classical | | (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. |