| CTRI Number |
CTRI/2025/02/080676 [Registered on: 17/02/2025] Trial Registered Prospectively |
| Last Modified On: |
27/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Efficacy Of Amlaki Churna In Preventing Hridya Roga |
|
Scientific Title of Study
|
to evaluate the efficacy Of Amlaki Churna in preventing hridya roga-Single Arm Study |
| 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 Ragini Sharma |
| Designation |
MD SCHOLAR (swasthavritta) |
| Affiliation |
Chaudhary brahm prakash ayurveda charak sansthan,khera dabar,110073 |
| Address |
PG Department of swasthavritta Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh
PG Department of swasthavritta Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh
South West
DELHI
110073
India |
| Phone |
8920898280 |
| Fax |
|
| Email |
raginisharma9468@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr rakesh kumar verma |
| Designation |
MD scholar (swasthvritta) |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
PG Department of swasthvritta, Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh
South West
DELHI
110073
India |
| Phone |
9990149662 |
| Fax |
|
| Email |
rakeshverma2399@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr rakesh kumar verma |
| Designation |
MD scholar (swasthvritta) |
| Affiliation |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
| Address |
PG Department of swasthvritta, Chaudhary Brahm Prakash Ayurved Charak Sansthan Khera Dabar Najafgarh
South West
DELHI
110073
India |
| Phone |
9990149662 |
| Fax |
|
| Email |
rakeshverma2399@gmail.com |
|
|
Source of Monetary or Material Support
|
| chaudhary brahm prakash ayurveda charak sansthan,khera dabar,najafgarh,110073,delhi,
India |
|
|
Primary Sponsor
|
| Name |
Chaudhary Brahm Prakash Ayurveda Charak Sansthan |
| Address |
Khera Dabar, Najafgarh, Delhi-110073 |
| Type of Sponsor |
Government medical college |
|
|
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 ragini sharma |
Chaudhary Brahm Prakash Ayurved Charak Sansthan |
PG Department of swasthavritta, Chaudhary Brahm Prakash Ayurved Charak Sansthan, Khera Dabar,Najafgarh
South West
DELHI |
08920898280
raginisharma9468@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-CBPACS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
hridya roga |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: amlaki churna, Reference: charak chikitsa 27, Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 60 Days, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals of either sex aged 30-50 years irrespective of their occupation and socioeconomic status
2. Individuals having LDL more than 150mg/dl or  Total cholesterol more than 250mg/dl - 270mg/dl
3. Willing and able to participate for 9 weeks
4. Individuals with informed consent
5.obese patient -BMI more than 25
6.pre hypertensive patient [BP more than 140/80 mmHg ]-not on medication
7.patient having complaint of headache
8.sedentary lifestyle
9.Individuals whose having rasadhatu dushti. |
|
| ExclusionCriteria |
| Details |
1. Individuals who have received any medicines related to cardiac disorders(Modern Drug) within last 8
weeks.
2. Individuals having Type III and Type IV hypercholesterolaemia.
3. Individuals with poorly controlled Hypertension (more than 160 / 100 mm Hg).
4. Individuals with evidence of malignancy.
5. Individuals on prolonged (more than 6 weeks) medication with antidepressants, corticosteoids, anticholinergics,
immunosuppressants, oral contraceptive pills or estrogen replacement therapy etc. or any other drugs that may
have an influence on the outcome of the study.
6. Individuals suffering from major systemic illness necessitating long term drug treatment (Rheumatoid
arthritis, Tuberculosis, Psycho-Neuro-Endocrinal disorders, etc.).
7. Individuals who have a past history of Atrial Fibrillation, Acute Coronary Syndrome, Myocardial
Infarction, Stroke or Severe Arrhythmia in the last 6 months.
8. Symptomatic patient with clinical evidence of Heart failure.
9. Individuals having uncontrolled Diabetes Mellitus i.e HbA1c more than 10%.
10. Individuals with concurrent serious hepatic disorder (defined as aspartate aminotransferase (AST) and /
or alanine aminotransferase (ALT), total bilirubin or alkaline phosphatase (ALP) more than 2 times upper normal limit)
or renal disorders (defined as S.creatinine more than 1.2mg/dl), severe pulmonary dysfunction (uncontrolled asthma
and chronic obstructive pulmonary disease [COPD]), inflammatory bowel disease or any other condition that
may jeopardize the study.
11. Pregnant/ lactating females.
12. Individuals on oral contraceptives.
13. Alcoholics and/or drug abusers.
14. H/o hypersensitivity to any of the trial drugs or their ingredients.
15. Individuals who have completed participation in any other clinical trial during the past six (06) months.
Any other condition which the Principal Investigator thinks may jeopardize the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the efficacy of AMLAKI CHURNA in preventing HRIDYA ROGA |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in quality of life[SF-36]
Improvement in assessment criteria[RAS-RCVD SCALE]
Improvement in deranged lipid profile. |
60 Days |
|
|
Target Sample Size
|
Total Sample Size="151"
Sample Size from India="151"
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)
|
17/02/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
CARDIOVASCULAR DISEASEs are group of disorders of the heart and blood vessels and also include coronary heart disease, cerebrovascular disease, rheumatic heart disease and other conditions In classical literature rasadahtudushti is a major cause of heart diseases and rasadahtudushti is involved in pathophysiology of hridya roga.Some medicinal plants and food components (as monotherapy or adjunct to standard pharmacotherapy) have traditionally been used to treat CVD and have demonstrated various cardiovascular pharmacological effects.Emblica officinalis is one of the medicinal plants whose cardiovascular effects have been considered both in the traditional medicine and in the modern scientific literature. Hence based on the above review It is believed that amlaki churna possess properties that may help prevent heart disease, which is why we are conducting this study to investigate its potential effects on cardiovascular health. 3gm amlaki with lukewarm water given to patients initially for 20 days then after follow up drug will be given for next 20 days. 5. Follow up after 20 days for assessment. |