| CTRI Number |
CTRI/2025/11/097045 [Registered on: 07/11/2025] Trial Registered Prospectively |
| Last Modified On: |
|
| 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
|
Effect Of Ayurvedic Herbal Formulation (Amrutadi Lipicare) In Dyslipidaemia |
|
Scientific Title of Study
|
Assessment Of Efficacy Of Amrutadi Lipicare In Dyslipidaemia-A Randomized Controlled Clinical 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 Payal Maheriya |
| Designation |
Kayachikitsa Postgraduate Scholar |
| Affiliation |
G J Patel Institute of Ayurvedic Studies & Research |
| Address |
Department of Kayachikitsa OPD No 14 S G Patel Ayurveda Hospital and Maternity Home New Vallabh Vidyanagar Anand Gujarat, India 388121 Anand GUJARAT 388121 India
Anand
GUJARAT
388121
India |
| Phone |
7874857371 |
| Fax |
|
| Email |
payalmaheriya2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manchak Kendre |
| Designation |
Professor & HOD |
| Affiliation |
G J Patel Institute of Ayurvedic Studies & Research |
| Address |
Department of Kayachikitsa OPD No 14 S G Patel Ayurveda Hospital and Maternity Home New Vallabh Vidyanagar Anand Gujarat, India-388121 Anand GUJARAT 388121 India
Anand
GUJARAT
388121
India |
| Phone |
9429200112 |
| Fax |
|
| Email |
manchak.kendre@cvmu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Payal Maheriya |
| Designation |
Kayachikitsa Postgraduate Scholar |
| Affiliation |
G J Patel Institute of Ayurvedic Studies & Research |
| Address |
Department of Kayachikitsa OPD No 14 S G Patel Ayurveda Hospital and Maternity Home New Vallabh Vidyanagar Anand Gujarat India-388121 Anand GUJARAT 388121 India
Anand
GUJARAT
388121
India |
| Phone |
7874857371 |
| Fax |
|
| Email |
payalmaheriya2@gmail.com |
|
|
Source of Monetary or Material Support
|
| S. G. Patel Ayurveda Hospital and Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India-388121 Anand GUJARAT 388121 India |
|
|
Primary Sponsor
|
| Name |
Dr.Payal Maheriya |
| Address |
Department of Kayachikitsa, OPD No. 14, S. G. Patel Ayurveda Hospital and Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India-388121 Anand GUJARAT 388121 India |
| 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 |
| DrPayal Maheriya |
S. G. Patel Ayurveda Hospital and Maternity Home. |
Department of Kayachikitsa, OPD No. 14, S. G. Patel Ayurveda Hospital and Maternity Home, New Vallabh Vidyanagar, Anand, Gujarat, India-388121 Anand GUJARAT 388121 India
Anand
GUJARAT |
7874857371
payalmaheriya2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| G.J.Patel Institute of Ayurvedic Studies and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E789||Disorder of lipoprotein metabolism, unspecified. Ayurveda Condition: MEDOVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Amrutadi Lipicare, Reference: Charak Samhita Sutra 21/22-24, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Warm water), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Amalaki Churna, Reference: Bhavaprakash, Route: Oral, Dosage Form: Churna/ Powder, Dose: 12(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: Warm water), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
69.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients having one or more abnormal lipid levels in their lipid profile investigation.
2.Individuals willing to participate in the clinical trial and provide informed consent.
3.Patient willing to discontinue Anti-lipidemic drug during research study.
4.Lipid profile ranges included for patient selection are as follows:(As per NCEP ATP 3
Guideline)
Serum Cholesterol: 200-239 mg/dL and above 240 mg/dL
Serum Triglyceride: between 150-499 mg/dL
Serum LDL between 130-189 mg/dL
Serum HDL between 10-40 mg/dL
5. BMI less than30 kg/m2
|
|
| ExclusionCriteria |
| Details |
1)Pregnant and lactating women.
2) Patients suffering from acute or chronic major illness which may interferes the study result.
3) Patients with very high levels of cholesterol, specifically:
Total Cholesterol: greater than 400 mg/dL
Serum Triglyceride: greater than 500 mg/dL
Serum LDL Cholesterol: greater than 190 mg/dl
4)BMI greater than 30 kg/m2
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Amrutadi Lipicare may show a positive impact on the lipid profile of patients with
Dyslipidaemia. |
2 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Amrutadi Lipicare may demonstrate a positive impact on the Body Mass Index (BMI) of patients with Dyslipidaemia. |
2 Months |
|
|
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/ Phase 4 |
|
Date of First Enrollment (India)
|
22/12/2025 |
| 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="2"
Months="0"
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
|
Dyslipidaemia is a metabolic disorder characterized by abnormally high or low levels of lipids (e.g., fats, triglycerides, cholesterol, phospholipids) or lipoproteins in the blood. It is a significant risk factor for the development of atherosclerotic cardiovascular diseases (ASCVD), including coronary artery disease, cerebrovascular disease, and peripheral artery disease. So, this Study intends to find out the efficacy of Amrutadi Lipicare in dyslipidaemia. The subjects are randomly selected and grouped into two groups as follows: Group-A: Amrutadi Lipicare 6 gm twice daily empty stomach with warm water at 7 AM & 5 PM and in Group B: Controlled group of Dyslipidaemia patients treated with Amalaki churna 6 gm twice daily empty stomach with warm water at 7 AM & 5 PM. Total duration of study is 2 Months. |