| CTRI Number |
CTRI/2026/01/101907 [Registered on: 23/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| 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
|
A study comparing an Ayurvedic medicine(Arthrakshak Dm)and atorvastatin for high cholesterol in diabetic patients |
|
Scientific Title of Study
|
Open Labelled, Active Controlled, Randomized Comparative Clinical Trial to Evaluate the Efficacy of Arthrakshak-DM in the Management of Diabetic-induced Dyslipidemia |
| 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 Jayant Sharma |
| Designation |
Pg scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Opd No 116 Department of Kayachikitsa Parul Ayurved Hospital Parul university
AP-Limda TAL-Waghodia Vadodara Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9354269832 |
| Fax |
|
| Email |
jayantsharma362@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manu R |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Opd No 116 Department of Kayachikitsa Parul Ayurved Hospital Parul university
AP-Limda TAL-Waghodia Vadodara Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
8160858967 |
| Fax |
|
| Email |
manu.r260022@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manu R |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Opd No 116 Department of Kayachikitsa Parul Ayurved Hospital Parul university
AP-Limda TAL-Waghodia Vadodara Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
8160858967 |
| Fax |
|
| Email |
manu.r260022@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Parul Institute of ayurved Parul university Ap-Limda Tal-Waghodia Dis-vadodara Gujarat India-
391760 |
|
|
Primary Sponsor
|
| Name |
Parul Institute of Ayurved |
| Address |
Faculty of Ayurved Parul university Ap-Limda Tal-Waghodia Dis-vadodara
Gujarat India-391760 |
| Type of Sponsor |
Private 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 Jayant Sharma |
Parul Ayurved Hospital |
Opd No.116 Department of Kayachikitsa
Parul Ayurved Hospital Parul university
AP-Limda TAL-Waghodia Vadodara
Gujarat
Vadodara
GUJARAT
Vadodara
GUJARAT |
9354269832
jayantsharma362@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul Institute of Ayurved |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E116||Type 2 diabetes mellitus with other specified complications. Ayurveda Condition: MEDOROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Arthrakshak Dm, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 500(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: 2-2-2 Capsules TID | | 2 | Comparator Arm (Non Ayurveda) | | - | Tab Atorvastatin | 20mg After food HS 20mg tablet for 3months |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either gender aged between 18 years and 70 years both years inclusive.
Patients having HbA1c levels between 6.5 percent and 10.0 percent indicating Type 2 Diabetes Mellitus.
Patients must meet at least one of the following lipid profile criteria as per ADA ESC LAI thresholds according to 2024 guidelines.
Low density lipoprotein cholesterol equal to or more than 100 milligram per decilitre.
Triglyceride level equal to or more than 150 milligram per decilitre.
Non high density lipoprotein cholesterol equal to or more than 130 milligram per decilitre.
High density lipoprotein cholesterol equal to or less than 40 milligram per decilitre in males or equal to or less than 50 milligram per decilitre in females.
|
|
| ExclusionCriteria |
| Details |
Patients having severe dyslipidemia with total cholesterol more than 360 milligram per decilitre.
Patients having low density lipoprotein cholesterol more than 190 milligram per decilitre.
Patients having triglyceride levels more than 400 milligram per decilitre.
Patients having high density lipoprotein cholesterol more than 40 milligram per decilitre in males or more than 50 milligram per decilitre in females.
Patients with dyslipidemia due to drug induced causes such as glucocorticoids.
Patients with a recent history of myocardial infarction heart failure or stroke.
Pregnant and lactating women.
Patients with a history of alcoholism.
Patients with known allergy or hypersensitivity to any of the study drugs.
Patients with known immunosuppressive conditions such as human immunodeficiency virus infection.
Patients with known active infectious diseases such as tuberculosis or hepatitis B. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of Arthrakshak-DM in reducing lipid profile abnormalities (total cholesterol, LDL, triglycerides, and HDL) in patients with Type II Diabetes-induced dyslipidemia .
|
Lipid Profile (TC, LDL, HDL, TG )HBA1c,ECG,S.insulin on screening visit and 90th day
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the effect of Arthrakshak-DM on fasting blood glucose and HbA1c levels in patients with Type II Diabetes
To assess the effect of Arthrakshak-DM on Subjective criteria
To observe the impact of Arthrakshak-DM on body weight and BMI in study participants over the intervention period |
FBS on screening visit, visit 30th day,visit 60th day ,visit 90th day |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/02/2026 |
| 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
|
Diabetic dyslipidemia is a common metabolic disorder in patients with type 2 diabetes mellitus and is associated with increased risk of cardiovascular diseases. It commonly occurs due to decreased insulin sensitivity leading to altered lipid metabolism in diabetic patients. Conventional lipid lowering drugs such as statins are effective but may be associated with long term adverse effects and intolerance in some patients. Ayurveda describes dyslipidemia under conditions such as Medoroga and Kapha Medo Dushti. The present study is an open label randomized active controlled clinical trial designed to evaluate the effect of an Ayurvedic formulation Arthrakshak DM in comparison with Atorvastatin in patients with type 2 diabetes induced dyslipidemia. A total of 60 eligible participants will be randomly allocated into 2 groups. Group A will receive Arthrakshak DM capsules while Group B will receive Atorvastatin tablets for a duration of 90 days. The primary outcome measures include changes in lipid profile parameters such as total cholesterol low density lipoprotein high density lipoprotein and triglycerides. Changes in serum insulin levels and insulin sensitivity will also be observed to assess their role in diabetic induced dyslipidemia. Secondary outcome measures include changes in fasting blood sugar HbA1c body weight body mass index and improvement in subjective symptoms related to dyslipidemia. Safety will be assessed by monitoring adverse events throughout the study period. This study aims to assess whether Arthrakshak DM is effective and safe in managing diabetic dyslipidemia and to generate clinical evidence for its potential role as an alternative or complementary treatment option. |