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CTRI Number  CTRI/2024/02/063165 [Registered on: 26/02/2024] Trial Registered Prospectively
Last Modified On: 03/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To Study The Effect Of Loha Rasayana In Comparison To Vyoshadi Saktu On Atherogenic Index of Plasma (AIP) In Patients Of Metabolic Syndrome - An Open Labelled Randomized Comparative Clinical Trial.  
Scientific Title of Study   Efficacy Of Loha Rasayana and Vyoshadi Saktu On Atherogenic Index Of Plasma (AIP) In Patients Of Metabolic Syndrome - An Open Labelled Randomized Comparative Clinical Trial. 
Trial Acronym  METS 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Prof Jonah Sandrepogu 
Designation  Head of Department, Department of Kayachikitsa, AIIA New Delhi 
Affiliation  All India Institute of Ayurveda, New Delhi 
Address  Department of Kayachikitsa, All India Institute of Ayurveda Gauthampuri, Mathura road, New Delhi

South
DELHI
110076
India 
Phone  9448262298  
Fax    
Email  jonahdr@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Jonah Sandrepogu 
Designation  Head of Department, Department of Kayachikitsa, AIIA New Delhi 
Affiliation  All India Institute of Ayurveda, New Delhi 
Address  Department of Kayachikitsa, All India Institute of Ayurveda Gauthampuri, Mathura road, New Delhi

South
DELHI
110076
India 
Phone  9448262298  
Fax    
Email  jonahdr@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Chandrika Kuraakula 
Designation  PhD Scholar, Department of Kayachikitsa 
Affiliation  All India Institute of Ayurveda, New Delhi 
Address  All India Institute of Ayurveda, New Delhi

South
DELHI
110076
India 
Phone  8686981274  
Fax    
Email  kuraakulac@gmail.com  
 
Source of Monetary or Material Support  
Department of Kayachikitsa, All India Institute of Ayurveda, New Delhi 
 
Primary Sponsor  
Name  All India Institute of Ayurveda 
Address  All India Institute of Ayurveda New Delhi Gauthampuri Mathura road New Delhi 110076 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Prof Jonah Sandrepogu  All India Institute of Ayurveda, New Delhi  Department of Kayachikitsa, OPD no 5, Kayachikitsa OPD,
South
DELHI 		 9448262298

jonahdr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC), All India Institute of Ayurveda, New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E888||Other specified metabolic disorders. Ayurveda Condition: MEDOROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Loha Rasayana, Reference: Chakradutta Sthoulyadhikara, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 42 Days, anupAna/sahapAna: Yes(details: -warm water), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Vyoshadi Saktu, Reference: Chakradatta Sthoulyadhikara, Route: Oral, Dosage Form: Sattu, Dose: 60(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 42 Days, anupAna/sahapAna: Yes(details: -warmwater), Additional Information: -
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients fulfilling the Diagnostic criteria of Metabolic Syndrome.
Patients fit for Virechana Karma.
 
 
ExclusionCriteria 
Details  Age group below 30 years and above 60 years.
Patients not fulfilling the Diagnostic criteria of Metabolic Syndrome
 
 
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 
• Changes in the Atherogenic Index of Plasma

 		 3 timepoints
1. Baseline
2. 4 weeks
3. 8 weeks

 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in the Medoroga Lakshana, Anthropometric measurements, Fasting Blood Glucose levels & Blood Pressure.
Changes in the number of components of the metabolic syndrome;
Changes in single indicators (waist circumference, blood pressure, TG, HDL-C) in metabolic syndrome;
Ankle brachial index;
Glycated hemoglobin (HbA1c);
C-reactive protein;
Urinary microalbumin to creatinine ratio (ACR).
 		 3 timepoints
1. Baseline
2. 4 weeks
3. 8 weeks 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   01/03/2024 
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="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  

Cardiovascular disease (CVD) is the cause of one-third of deaths worldwide and this status will progress because of increasing risk of CVD risk factors. The most important risk factors for CVD consist of Dyslipidemia, Hypertension, Obesity, Physical inactivity, poor diet, and smoking, which are the constituents of Metabolic Syndrome. Among these, plasma lipid profile is the major risk factor and predictor for CVD. Many clinical studies have made an effort to introduce a better marker of Atherogenic Dyslipidemia that can predict the risk of CVD, which is useful in evaluating response to treatment instead of the classical ratio. Atherogenic Index of Plasma (AIP) is a logarithmically transformed ratio of molar concentration of Triglycerides to HDL cholesterol. It has been shown that AIP is a strong marker in predicting the risk of Atherosclerosis and Coronary Heart Disease. AIP reflects the true relationship between protective and atherogenic lipoprotein and is associated with pre- and anti-atherogenic lipoprotein particle size. Contemporary treatment modalities concentrate on the treatment of the specific features of the conditions separately, with the overall goal of reducing the risk of cardiovascular disease and type 2 DM, but unfortunately patients end up with other complications due to the overburden of medications. There is an absolute need for a single noble strategy that can strike the ongoing disease pathology and reduce the burden upon the patient, and save the life from complications like Atherosclerosis and Coronary Heart Disease. Hence the current study attempts to evaluate the efficacy of trial drugs mainly on AIP which is the novel marker for Atherosclerosis and Coronary Heart Disease, especially in patients of Metabolic Syndrome as they are at high risk of developing CVD.

 AIM: To assess the risk of Atherosclerosis and Coronary Heart Disease in patients with Metabolic Syndrome.

 PRIMARY OBJECTIVE: To evaluate the efficacy of Loha rasayana in comparison to Vyoshadi saktu on the Atherogenic Index of Plasma

  SECONDARY OBJECTIVE: To assess the changes in the Medoroga Lakshana, Anthropometric measurements, Single Indicators of MetS, Ankle-brachial index, HbA1c, C-reactive protein, Urinary microalbumin to creatinine ratio (ACR).

6.1.  STUDY TYPE: Open Labelled Randomized Comparative Clinical Trial

 

Study design

Pre and Post

Purpose

Treatment

Timing

Prospective

End Point

Clinical Efficacy

Masking

Open Label

No. of groups

Two

Sample size

80 (40 in each group)

Duration of Trial

56 days

INCLUSION CRITERIA:

·       Age group 30-60 years irrespective of gender.

·       Patients fulfilling the Diagnostic criteria of Metabolic Syndrome.

·       Patients fit for Virechana Karma.

 EXCLUSION CRITERIA:

·       Age group below 30 years and above 60 years.

·       Patients not fulfilling the Diagnostic criteria of Metabolic Syndrome

·       Uncontrolled Diabetes patients of (FBS >200mg/dl, PPBS >350mg/dl, HbA1C >10%)

·       Uncontrolled Hypertensive patients (BP> 170/100mm of Hg)

·       Patients under severe illness - Cardiovascular disorders, Encephalopathy, Tuberculosis, Chronic Renal and Liver disorders, Endocrine disorders like Cushing’s syndrome and other malignancies.

·       Patients unfit for Virechana Karma.

·       Pregnant women or willing-to-be pregnant or lactating mothers

·       Patients who are hypersensitive to any of the ingredients of trial drugs.

·       For any reason, the investigator may consider a subject inappropriate for participation in this study.

Total duration of trial (clinical trial duration + Follow-up duration) = 56days+42days = 98days Visit of patient during trial period on every 0,15,30,56 days. Follow-up will be done for 42 days after the intervention.

 
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