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CTRI Number  CTRI/2025/03/081508 [Registered on: 03/03/2025] Trial Registered Prospectively
Last Modified On: 13/08/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of two different Ayurvedic formulations in the management of Madhumeha(Type 2 Diabetes Mellitus) 
Scientific Title of Study   A comparative clinical study of Mesashrungi vati with Vijayksharadi kvatha and Mamajjakadi Ghanvati with Nyagrodhadi kvatha in the patients of Madhumeha (Type 2 diabetes mellitus) 
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 Jigna C Maru 
Designation  PG Scholar 
Affiliation  J.S. Ayurveda Mahavidyalaya and P.D. Patel Ayurveda Hospital 
Address  Department of Kayachikitsa, J S Ayurveda Mahavidyalaya, college road, Nadiad Kheda GUJARAT 387001 India

Kheda
GUJARAT
387001
India 
Phone  9316573770  
Fax    
Email  jignamaru413@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Dr Dhaval M Dholakiya 
Designation  Professor of Department of Kayachikitsa 
Affiliation  J.S. Ayurveda Mahavidyalaya and P.D. Patel Ayurveda Hospital 
Address  Department of Kayachikitsa, J S J S Ayurveda Mahavidyalaya, college road, Nadiad Kheda GUJARAT 387001 India

Kheda
GUJARAT
387001
India 
Phone  8980925520  
Fax    
Email  vddhavaldholakiya1910@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Dr Dhaval M Dholakiya 
Designation  Professor of Department of Kayachikitsa 
Affiliation  J.S. Ayurveda Mahavidyalaya and P.D. Patel Ayurveda Hospital 
Address  Department of Kayachikitsa, J S J S Ayurveda Mahavidyalaya, college road, Nadiad Kheda GUJARAT 387001 India


GUJARAT
387001
India 
Phone  8980925520  
Fax    
Email  vddhavaldholakiya1910@gmail.com  
 
Source of Monetary or Material Support  
Sundar Ayurvedic Teaching Pharmacy J S Ayurved Mahavidyalaya Nadiad,Gujrat India-387001 
 
Primary Sponsor  
Name  J S Ayurved Mahavidhyalaya  
Address  J S Ayurved Mahavidhyalaya collage road Nadiad 387001 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
J S Ayurved Mahavidhyalaya   J S Ayurved Mahavidhyalaya collage road Nadiad 387001 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jigna Maru  J S Ayurved Mahavidhyalaya and P D Patel Ayurvedic Hospital  PG Department of Kayachikitsa, J S Ayurveda Mahavidyalaya, collage road, Nadiad Kheda GUJARAT 387001 India
Kheda
GUJARAT 		 09316573770

jignamaru413@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee for Research project  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: MADHUMEHAH/KSHAUDRAMEHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Mamejakadi ghanvati, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 2000(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: jala), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Nyagrodhadi kvatha, Reference: Sharangdhar samhita madhyam khadnda chep 2-111 to 114 , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -
3Comparator ArmDrugClassical(1) Medicine Name: Meshshringi vati, Reference: Api part 1 volume 5 page no 114 addition 1st, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 2000(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: jala), Additional Information: -
(2) Medicine Name: Vijaysaradi kvatha, Reference: Sushruta samhita sutrasthana38/12, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 10(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Clinical features of madhumeha (diabetes mellitus) as mentioned in diagnostic
criteria.
2.Patient between the age of 18 to 70 year.
3.Patient with random blood sugar above 140 to 180 mg/dl
4.Patient with fasting blood sugar between 126 to 180 mg/dl and postprandial blood
glucose between 200 to 280 mg/dl
5.Glycosylated hemoglobin value between 6.5 % to 8.0 %.
6.Urine sugar nil to ++++ 
 
ExclusionCriteria 
Details  1.Patient of age less than 18 and more than 70 year.
2.Patient who were dependent on insulin.
3.Pregnant and lactating women.
4.Patient with genetic syndromes associated with type 2 diabetes mellitus like
down’s syndrome, Klinefelter’s syndrome, turner’s syndrome.
5.Patients having complication of diabetes like nephropathy, retinopathy, diabetic
foot, carbuncles.
6.Patient with disease like cancer, tuberculosis, severe cardiovascular diseases. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To find out the effect of mesashrungi vati with vijayasaradi
kvatha in compare to mamajjakadi ghanavati with nyagrodhadi kvatha by observing
the changes in post-prandial urine sugar and post-prandial blood sugar in the patient
of madhumeha (diabetes mellitus). 		 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
1) To find out the changes of signs & symptoms in both groups of the patients of
madhumeha (diabetes mellitus)
2) To find out the changes in Hba1c after taking of mesashrungi vati with vijayasaradi
kvatha & mamajjakadi ghanavati with nyagrodhadi kvatha in the patients of
madhumeha (diabetes mellitus) 		 3 months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="36" 
Phase of Trial   N/A 
Date of First Enrollment (India)   12/03/2025 
Date of Study Completion (India) 01/06/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 no 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		 The study concludes that madhumeha is chronic life style related metabolic disorder involving kapha,meda,agnimandya and kleda vriddhi. both tratment regimens produced significant improvement in clinical and biochemical parameters with no significant difference between the group (p>0.05), indicating comparable effectiveness and acceptance of null hypothesis. the therapeutic effect of both regimens can be attributed to dosa dushya pratyanic cikitsa ,acting through dipan pachan,medohar and  kleda sosana mechanisms, leading ti improved metabolic function and sustained glycaemic control. the observed reduction in dependence on conventional antidiabetic medication further ubderscores their  significant adjunctive and disease modifying potential.
thus, both intervention are safe , effective and clinically beneficial in the management of madhumeh.
ultimately, true management of madhumeh lies ont merely in glycaemic regulation, but in correcting the underlying samprapti to restore mrtabolic balance.
 
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