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CTRI Number  CTRI/2025/10/096255 [Registered on: 21/10/2025] Trial Registered Prospectively
Last Modified On: 21/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   To compare the effect of Vamana, Virechana, and Basti on serum adiponectin levels in patients of T2DM with obesity (sthula pramehi) 
Scientific Title of Study   A COMPARATIVE CLINICAL STUDY TO EVALUATE THE EFFECT OF VAMANA, VIRECHANA AND BASTI ON SERUM ADIPONECTIN LEVEL IN THE MANAGEMENT OF T2DM WITH OBESITY (STHULA PRAMEHI) AN EXPLORATORY 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 Nicky Yadav 
Designation  MD Scholar 
Affiliation  All India Institute of Ayurveda  
Address  7th floor,Department of Panchakarma academic block, All India Institute of ayurveda Gautampuri Sarita vihar , delhi
Room no.703,Department of Panchakarma,Academic block,All India Institute of Ayurveda,Gautampuri Sarita vihar Delhi
South
DELHI
110076
India 
Phone  8384087195  
Fax    
Email  yadavnic264@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Santosh Kumar Bhatted 
Designation  Professor 
Affiliation  All India Institute of Ayurveda  
Address  7th floor,Department of Panchakarma Academic Block, All India Institute of ayurveda Gautampuri,Sarita vihar, delhi
Room no.703,Department of Panchakarma,Academic block,All India Institute of Ayurveda,Gautampuri Sarita vihar Delhi
South
DELHI
110076
India 
Phone  9414048459  
Fax    
Email  santoshbhatted@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nicky Yadav 
Designation  MD Scholar 
Affiliation  All India Institute of Ayurveda  
Address  7th floor,Department of Panchakarma academic block, All India Institute of ayurveda Gautampuri Sarita vihar , delhi
Room no.703,Department of Panchakarma,Academic block,All India Institute of Ayurveda,Gautampuri Sarita vihar Delhi
South
DELHI
110076
India 
Phone  8384087195  
Fax    
Email  santoshbhatted@rediffmail.com  
 
Source of Monetary or Material Support  
All India Institure of Ayurveda Mathura road sarita vihar new delhi 110076 
 
Primary Sponsor  
Name  All India Institure of Ayurveda  
Address  7th Floor,Department of Panchakarma,Academic Block,All india institute of ayurveda,Gautampuri puri awas,Sarita Vihar,Delhi  
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 
Dr Nicky Yadav  All India Institute of Ayurveda  Room 703, 7th floor, department of panchakarmaAll India Institute of Ayurveda.gautampuri, Mathura road sarita vihar new delhi 110076
South
DELHI 
08384087195

yadavnic264@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
division of translation research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmProcedure-dIpana , दीपन ,Pachana (Procedure Reference: Sharangdhara , Procedure details: Deepana and Pachana play an important role as purvakarma of shodhana (biopurification) procedures.)
2Intervention ArmProcedure-snehapAna-karma, स्नेहपान-कर्म (Procedure Reference: Ashtanga Hridya, Procedure details: Snehapana is a therapeutic procedure in ayurveda involving the oral intake of medicated ghee or oils , primarily used a preparatory step for detoxification(therapies like panchakarma))
(1) Medicine Name: Murchita tila taila, Reference: Charaka , Route: Oral, Dosage Form: Taila, Dose: 30(ml), Frequency: od, Duration: 5 Days
3Intervention ArmProcedure-virecana-karma, विरेचन-कर्म (Procedure Reference: Ashtanga hridya, Procedure details: Virechana means therapeutic purgation-the expulsion of vitiated Pitta dosha(along with kapha and vata) throughthe anal route.)
4Intervention ArmProcedure-bastikarma, बस्तिकर्म (Procedure Reference: Ashtanga Hridya, Procedure details: Basti is said to be the supreme therapy,capable of curing many diseases. main action is eliminates vitiated vata dosha, along with other doshas and toxins.)
5Intervention ArmDrugClassical
6Intervention ArmDrugClassical(1) Medicine Name: Guduchibhadramustadi churna, Reference: Charaka sutrasthana chapter 21, Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Ushna jala), Additional Information: -As a shamanaushadhi
7Intervention ArmProcedure-vamana-karma/ pracCardanam, वमन-कर्म/ प्रच्छर्दनम् (Procedure Reference: Ashtang hridya, Procedure details: Vamana is one of the five main cleansing treatments (Panchakarma) in ayurveda.It primarly cleanses the body by expelling excess kapha and pitta dosha from the stomach through the oral route.))
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient having classical signs and symptoms of Diabesity or Sthula Pramehi according to Ayurveda as well as modern science.

Patients diagnosed with Diabetes or Pre-Diabetes.

Body Mass Index more than twenty-three and less than forty kilograms per meter square.

Fasting Blood Sugar more than one hundred ten milligrams per decilitre and up to two hundred milligrams per decilitre.

Postprandial Blood Sugar more than one hundred forty milligrams per decilitre and up to three hundred milligrams per decilitre.

HbA1c between five point seven and seven point zero percent.

Age between thirty to sixty years.

Any gender.

All socio-economic statuses included.

Patient must be fit for Ayurvedic procedures including Vamana Virechana and Basti.


 
 
 
ExclusionCriteria 
Details  Age less than 30 years and more than 60 years.

Patients of Prameha having Body Mass Index less than 23 kg per square meter and more than 40 kg per square meter.

Patients with chronicity of disease more than five years.

Patients diagnosed with Type 1 Diabetes Mellitus.

Patients having complications of diabetes such as nephropathy diabetic ulcer etc.

Pregnant and lactating women.

Patients having high blood pressure more than 160 by 100 millimeters of mercury. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
an improvement in serum adiponectin levels following intervention with vamana, virechana and basti.  0th day,50th day 
 
Secondary Outcome  
Outcome  TimePoints 
objective parameter- An improvement in BMI, waist circumference, hip-waist ratio, FBS, PPBS, HbA1c, lipid profile subjective parameter-An improvement in signs & symptoms based on ayurvedic & modern parameters . Improvement in quality of life Results will guide future controlled trials & integrative management strategies.   0th day,20th day,50th day,100th day 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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)   20/03/2026 
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="0"
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  

INTRODUCTION

 Diabetes is a chronic disease that occurs either when the pancreas does not produce enough insulin or when the body cannot effectively use the insulin it produces. Insulin is a hormone that regulates blood sugar. Hyperglycaemia, or raised blood sugar, is a common effect of uncontrolled diabetes and over time leads to serious damage to many of the body’s systems, especially the nerves and blood vessels. impaired insulin secretion, and increased glucose production. Diabesity, the term coined to show the strong interlink between obesity and diabetes, is the direct co nsequence of the obesity pandemic, and poses significant challenges in the management of the disease. The global prevalence of obesity is increasing rapidly with an exponential rise in incidence of type 2 diabetes mellitus in recent years. The worst metabolic consequence of obesity is type 2 diabetes mellitus , which substantially increases cardiovascular disease-related morbidity and mortality. Other obesity associated comorbidities such as dyslipidemia, hypertension, metabolic-associated fatty liver disease, obstructive sleep apnoea , heart failure, ischaemic heart disease, cancers and osteoarthritis further increase the morbidity, mortality, and health-related quality of life, especially when these patients additionally have T2DM

NEED OF STUDY - The rising prevalence of obesity-induced Type 2 Diabetes Mellitus (T2DM) poses a major global health burden, with increasing incidence in both urban and rural populations. Among various biomarkers, serum adiponectin has gained attention for its anti-inflammatory, insulin- sensitizing, and cardio-protective roles. While conventional treatments focus on glycemic control and metabolic risk reduction, they do not address the underlying pathophysiology from a holistic perspective. Ayurveda, with its comprehensive approach, offers Shodhana therapies (bio-purificatory procedures) like Vamana, Virechana, and Basti, which aim to eliminate the root cause (Dosha-Dushya imbalance), particularly addressing Kapha-Meda Dushti the core pathology in obesity and diabetes (Sthoulya-Prameha).

OBJECTIVES

PRIMARY OBJECTIVE—

To compare the effect of Vamana, Virechana, and Basti on serum adiponectin levels in patients of t2dm with obesity (sthula pramehi)

 SECONDARY OBJECTIVES-

1.  To assess changes in clinical parameters such as BMI, waist circumference, hip waist ratio.

2.  To assess changes in biochemical parameters like fasting blood sugar , postprandial blood sugar , HbA1c, and lipid profile.

3. To  compare the overall effect of these Panchakarma procedures in improving quality of life and disease outcome.

4. To assess changes in signs and symptoms based on ayurvedic and modern parameter

METHODOLOGY:

This study is a prospective, triple arm interventional clinical trial with an open-label design, conducted over a period of 2.5 years on diagnosed cases of psoriasis, in both outpatient and inpatient departments (OPD & IPD) of the All India Institute of Ayurveda (AIIA).


 
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