| 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 |
|
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Details of Secondary Sponsor
|
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| division of translation research |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Procedure | - | dIpana , दीपन ,Pachana | (Procedure Reference: Sharangdhara , Procedure details: Deepana and Pachana play an important role as purvakarma of shodhana (biopurification) procedures.)
| | 2 | Intervention Arm | Procedure | - | 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 | | 3 | Intervention Arm | Procedure | - | 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.)
| | 4 | Intervention Arm | Procedure | - | 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.)
| | 5 | Intervention Arm | Drug | Classical | | | | 6 | Intervention Arm | Drug | Classical | | (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 | | 7 | Intervention Arm | Procedure | - | 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.))
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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. |
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
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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 profilesubjective parameter-An improvement in signs & symptoms based on ayurvedic & modern parameters . Improvement in quality of lifeResults 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
|
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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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