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CTRI Number  CTRI/2025/08/092619 [Registered on: 07/08/2025] Trial Registered Prospectively
Last Modified On: 06/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to evaluate the effect of vamana therapy using madanphala in people with early signs of diabetes(prediabetes)  
Scientific Title of Study   Assessing the effectiveness of vamana karma using madanphala majja in the management of prameha purvarupa avastha (prediabetes) randomized controlled clinical trial 
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 Apurva Anil Gade 
Designation  MD Panchakarma Scholar 
Affiliation  C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad 431011  
Address  OPD NO. 15 C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 OPD NO.15 PANCHAKARMA DEPARTMENT

Aurangabad
MAHARASHTRA
431011
India 
Phone  9960145047  
Fax    
Email  apurvagade10@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Uday keshavrao Neralkar 
Designation  Head Of Department Panchakarma 
Affiliation  C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad 431011  
Address  OPD NO. 15 C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 OPD NO.15 PANCHAKARMA DEPARTMENT

Aurangabad
MAHARASHTRA
431011
India 
Phone  9850035061  
Fax    
Email  uneralkar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Apurva Anil Gade 
Designation  MD Panchakarma Scholar 
Affiliation  C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad 431011  
Address  OPD NO. 15 C.S.M.S.S Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad Maharashtra India 431011 OPD NO.15 PANCHAKARMA DEPARTMENT

Aurangabad
MAHARASHTRA
431011
India 
Phone  9960145047  
Fax    
Email  apurvagade10@gmail.com  
 
Source of Monetary or Material Support  
C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad 431011 
 
Primary Sponsor  
Name  C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad  
Address  C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad 431011 
Type of Sponsor  Private medical college 
 
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 Apurva Anil Gade  C.S.M.S.S. Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad 431011  OPD No.15, Department of Panchakarma
Aurangabad
MAHARASHTRA 
9960145047

apurvagade10@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Aurangabad   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:E00-E89||Endocrine, nutritional and metabolic diseases. Ayurveda Condition: PRAMEHA-PURVARUPAM, (2) ICD-10 Condition:E11||Type 2 diabetes mellitus. Ayurveda Condition: PRAMEHA-PURVARUPAM, (3) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHA-PURVARUPAM, (4) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHA-PURVARUPAM, (5) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHA-PURVARUPAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-vamana-karma/ pracCardanam, वमन-कर्म/ प्रच्छर्दनम् Pradhan Karma(Procedure Reference: Charak samhita, Procedure details: Purva Karma will include deepana and pachana with chitrakadi vati for 3 days. Snehapana with dhanvantaram ghrita will be administered for 3–7 days based on agni and koshtha. This will be followed by abhyanga and swedana using tilataila and dashamoola kashaya. Vamana karma will be performed using madanphala majja churna along with madanphala kashaya , and samsarjana krama will be given based on the type of shuddhi.)
(1) Medicine Name: Madanphala majja along with madanphala kashaya, Reference: Sushruta samhita,Sutrasthana 43/3, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 40(ml), Frequency: od, Duration: 1 Days
2Comparator ArmProcedure-vamana-karma/ pracCardanam, वमन-कर्म/ प्रच्छर्दनम् (Procedure Reference: Charak samhita, Procedure details: Deepana and pachana will be done with panchakola churna and nagarmotha churna for 3 days. Snehapana will be administered with murchhita ghrita for 5 days. Abhyanga and swedana will be performed using tilataila and dashamoola kwatha. Vamana karma will be performed using Ikshvaku churna with madhuyashti kashaya. Samsarjana Krama will be given for 5 days based on the type of shuddhi.)
(1) Medicine Name: Ikshvaku madhuyashti yoga, Reference: Charaka samhita,kalpasthana 3/14, Route: Oral, Dosage Form: Kwatha/Kashaya, Dose: 150(ml), Frequency: od, Duration: 1 Days
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patient of prameha purvarupa avastha.
Patient having an HbA1c level between 5.7 percent to 6.4 percent.
Patient of either sex and irrespective of their occupation, or socioeconomic status.  
 
ExclusionCriteria 
Details  Patient having HbA1c levels less than 5.7 percent and greater than 6.4 percent.
Age less than 30 years and greater than 60 years.
Patient of Type-1 DM or the patient of type-2 DM taking insulin.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduce HbA1c in percentage.
Improvement in signs and symptoms of prameha purvarupa avastha. 
For subjective criteria -0th day (baseline), after snehapana,after samsarjana krama,after 15th day of samsarjana krama.
For objective criteria - baseline,after 15th day of samsarjana krama. 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in overall energy levels. Changes in work productivity.  0th day (baseline), after snehapana,after samsarjana krama,after 15th day of samsarjana krama  
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
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)   18/08/2025 
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 increasing burden of lifestyle disorders, particularly prediabetes and diabetes, is a significant global public health concern. Prediabetes is a precursor to type 2 diabetes and is characterized by elevated blood sugar levels that are not yet high enough for a diabetes diagnosis. It affects millions and carries a high risk of progression if not managed early. In Ayurveda, prameha and its early manifestations (purvarupa avastha) are considered treatable stages.
This randomized controlled clinical trial will evaluate the effectiveness of vamana karma using Madanphala Majja in the management of prameha purvarupa avastha, which corresponds to the prediabetic stage in modern medicine. According to Ayurvedic principles, bahudrava kapha and abaddha meda are the primary pathological factors in prameha. Therefore, Samprapti vighatana should focus on these two components. Shodhana karma eliminates the vitiated dosha through its nearest route; for kapha, this is via urdhvabhaga (oral route), making vamana karma the preferred approach.
Prameha is a metabolic disorder with kapha dominance, and the seat of Kapha is the urdhva amashaya. Thus, vamana karma offers a logical route for kapha expulsion. madanphala is considered a safe and effective vamaka dravya. In this study, eligible participants will be randomly divided into two groups: Group A will undergo vamana with Madanphala Majja yoga, and Group B will receive Vamana with Ikshvaku Madhuyashti kashaya yoga.
Both groups will follow a standardized Panchakarma protocol including Deepana-Pachana, Snehapana, Abhyanga, Swedana, Vamana Karma, and Samsarjana Krama. The primary outcomes will include improvement in subjective symptoms and reduction in HbA1c levels. This study aims to assess whether timely Ayurvedic purification therapy can prevent or delay the progression from prediabetes to type 2 diabetes, thereby contributing to integrative public health strategies.
 
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