| CTRI Number |
CTRI/2025/02/081252 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
15/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ayurvedic management of Atherogenic Dyslipidemia with Amritadi Guggulu and Phalatrikadi Kwatha along with lifestyle changes |
|
Scientific Title of Study
|
Efficacy of Amritadi Guggulu and Phalatrikadi Kwatha along with lifestyle modification in the management of Atherogenic Dyslipidemia- An open labelled single arm exploratory trial |
| Trial Acronym |
AD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shravani Uday Mahajan |
| Designation |
M.D. Scholar |
| Affiliation |
Institute of Teaching and Research in Ayurveda Jamnagar |
| Address |
Department of Kayachikitsa 4th floor academic building ITRA Jamnagar, Jamnagar, Gujarat-361008 India
Jamnagar
GUJARAT
361008
India |
| Phone |
9561447474 |
| Fax |
|
| Email |
shravanimahajan333@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhananjay V Patel |
| Designation |
Reader |
| Affiliation |
Institute of Teaching and Research in Ayurveda Jamnagar |
| Address |
Department of Kayachikitsa 4th floor academic building ITRA Jamnagar, Jamnagar, Gujarat-361008 India
Jamnagar
GUJARAT
361008
India |
| Phone |
9558805421 |
| Fax |
|
| Email |
dhanvantarihcare@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Shravani Uday Mahajan |
| Designation |
M.D. Scholar |
| Affiliation |
Institute of Teaching and Research in Ayurveda Jamnagar |
| Address |
Department of Kayachikitsa 4th floor academic building ITRA Jamnagar, Jamnagar, Gujarat-361008 India
Jamnagar
GUJARAT
361008
India |
| Phone |
9561447474 |
| Fax |
|
| Email |
shravanimahajan333@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Teaching and Research in Ayurveda, Opposite B division police station, Gurudwara road, Jamnagar-361008, Dist. Jamnagar, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Institute of Teaching and Research in Ayurveda Jamnagar |
| Address |
Institute of Teaching and Research in Ayurveda, Opposite City B division police station, Gurudwara road, Jamnagar, 361008, Gujarat, India |
| 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 Shravani Uday Mahajan |
PG hospital OPD no 11 Institute of teaching and Research in Ayurveda Jamnagar |
Department of Kayachikitsa 4th floor academic building ITRA Jamnagar, Jamnagar, Gujarat-361008 India
Jamnagar
GUJARAT |
9561447474
shravanimahajan333@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Institute of Teaching and Research in Ayurveda, Jamnagar-361008, Gujarat, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E782||Mixed hyperlipidemia. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Amritadi Guggulu, Reference: Bhavaprakasha, Route: Oral, Dosage Form: Guggulu , Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: Phalatrikadi kwatha), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age from 30 to 60 years, irrespective of gender, caste, religion and socioeconomic status.
2. Patient fulfilling diagnostic criteria (According to National Cholesterol Education Program, Adult Treatment Panel III- Sr.Triglycerides above 150 mg/dl, Sr.LDL above 100 mg/dl, Sr.HDL below 40 mg/dl)
3. BMI from 18.5 to 34.9 kg/m2 (Normal, overweight, obese class I)
4. Newly diagnosed cases of Atherogenic Dyslipidemia but not taking any Hypolipidemic drugs and previously diagnosed cases, inspite of taking hypolipidemic drugs fulfilling diagnostic criteria can be selected after giving proper washout period.
5. Patient willing for trial and ready to give written consent. |
|
| ExclusionCriteria |
| Details |
1. Age group below 30 years and above 60 years.
2. Lipid profile with very high level (Sr.Triglyceride above 499 mg/dl, Sr.LDL above 190 mg/dl.
3. BMI below 18.5 and above 34.9 kg/m2
4. Patient suffering from type I DM, poorly controlled DM type II (RBS above 200), poorly controlled HTN (Systolic BP above 160 mm of Hg, Diastolic BP above 100 mm of Hg), known cases of Hypothyroidism.
5. Patient with active liver disease, including those with primary biliary cirrhosis and unexplained persistent liver function abnormalities.
6. Patients with history of myocardial infraction, stroke or has undergone coronary artery bypass surgery, percutaneous transluminal coronary angioplasty or unstable or severe peripheral artery disease.
7. Drug induced hyperlipidemia (Glucocorticoids, diuretics)
8. Patient suffering from major systemic illness necessitating long term treatment (RA, PTB, malignancy, ARD, CKD)
8. Alcoholic or drug abuse patients.
9. Patient on oral contraceptives, pregnant female or planning for pregnancy, lactating mother. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Correction in Lipid profile (Mean reduction in the levels of Sr.Triglycerides and Sr.LDL while increase in Sr.HDL level) |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Reduction in BMI.
2. Reduction in Apolipoprotein B.
3. Reduction in the Atherosclerotic Cardiovascular Diseases (ASCVD) risk score and QRISK Score3. |
8 weeks |
|
|
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)
|
11/03/2025 |
| 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 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
|
The trial is exploratory clinical trial to evaluate the role of oral administration of Amritadi Guggulu and Phalatrikadi Kwatha along with lifestyle modification in the management of Atherogenic Dyslipidemia. Total 30 patient fulfilling diagnostic criteria and inclusion criteria will be enrolled in the study. Selected patients will be administrated Amritadi Guggulu (3 tablets of 500 mg each), twice a day, orally at early in the morning empty stomach before breakfast and after 5 hours of lunch along Phalatrikadi Kwatha (40 ml each time) as an Anupana for duration of 8 weeks. The haematological investigations, liver function tests, renal function tests, urine routine, ECG will be done before the trial while lipid profile and biomarker of dyslipidemia: Apolipoprotein-B will be done before and after trial. Proper dietary and physical regimen will be advised to all the patients. Patients will be advised to visit the hospital every fortnightly during the treatment for 8 weeks and after the completion of the therapy for the duration of 2 weeks at every week as a follow up.
|