| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | 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 | | 2 | Comparator Arm | Procedure | - | 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. |