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CTRI Number  CTRI/2025/02/080289 [Registered on: 10/02/2025] Trial Registered Prospectively
Last Modified On: 13/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Treatment of type 2 Diabetes mellitus by using two different Ayurvedic formulations. 
Scientific Title of Study   A single blind randomized controlled clinical study on the efficacy of Nimba aragwadhadi kashaya and Asanadi kashaya in the management of Prameha with special reference to Diabetes mellitus type 2 
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. Vishal Patil 
Designation  PG Research Scholar 
Affiliation  Shri D.G.M Ayurvedic medical College and hospital, PG and PhD research Centre, Dr S V Savadi road, Shivananda Nagar, Gadag 582103 
Address  DR. Vishal Patil Dept of Kayachikitsa OPD NO 3 Shri D.G.M Ayurvedic medical College and hospital, PG and PhD research Centre, Dr S V Savadi road, Shivananda Nagar, Gadag 582103

Gadag
KARNATAKA
582103
India 
Phone  6363085454  
Fax    
Email  vishalkpatil541@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Sumai M A 
Designation  Associate Professor  
Affiliation  Shri D.G.M ayurvedic medical college and hospital, PG and PhD research Centre, Gadag 582103 
Address  Dr.Sumai m a Dept of Kayachikitsa OPD NO 3 Shri D.G.M ayurvedic medical college and hospital, PG and PhD research Centre, Gadag 582103

Gadag
KARNATAKA
582103
India 
Phone  9448694900  
Fax    
Email  drsumaiyasamudri@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr.Vishal Patil 
Designation  PG Research Scholar 
Affiliation  Shri D.G.M Ayurvedic medical College and hospital, PG and PhD research Centre, Dr S V Savadi road, Shivananda Nagar, Gadag 582103 
Address  DR. Vishal Patil Dept of Kayachikitsa OPD NO 3 Shri D.G.M Ayurvedic medical College and hospital, PG and PhD research Centre, Dr S V Savadi road, Shivananda Nagar, Gadag 582103

Gadag
KARNATAKA
582103
India 
Phone  6363085454  
Fax    
Email  vishalkpatil541@gmail.com  
 
Source of Monetary or Material Support  
Shri D.G.M Ayurvedic medical College and hospital, PG and PhD research Centre, Dr S V Savadi road, Shivananda Nagar, Gadag 582103 
 
Primary Sponsor  
Name  Dr Vishal Patil  
Address  DR. Vishal Patil PG Research Scholar Dept of Kayachikitsa OPD NO 3 Shri D.G.M Ayurvedic medical College and hospital, PG and PhD research Centre, Dr S V Savadi road, Shivananda Nagar, Gadag 582103 
Type of Sponsor  Other [SELF] 
 
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 Vishal Patil  Shri D.G.M Ayurvedic medical College and hospital, PG and PhD research Centre , Gadag 582103  Department of Kayachikitsa OPD NO 3
Gadag
KARNATAKA 		 6363085454

vishalkpatil541@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SHRI D.G.M AYURVEDIC MEDICAL COLLEGE HOSITAL GADAG ETHICAL CLEARNCE COMMITTEE  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 ArmDrugClassical(1) Medicine Name: Asanadi Kashaya , Reference: Bhavaprakash samhita, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Jala (Water) ), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Nimba Aragwadadhi Kashaya, Reference: Sushrutha Samhita, Chikitsa Sthana, Prameha chikitsa Adhyaya, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 20(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Jala (Water) ), Additional Information: -
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Subjects having majority of clinical features of madhumeha like,
a) Excessive urination- Bahu Mutrata
b) Turbid urination - Avila Mutrata
c) Weakness-Dourbalya
d) Thirst – Pipasa
e) Excessive Hunger – Kshudhadhikyata

2.Age group of 30-65 years are included.
3.Newly detected subjects having Fasting Blood Sugar less than or equal to 180 mg/dL and Post Prandial Blood Sugar less than or equal to 315 mg/dL.
4.Non-complicated Non insulin-dependent-Diabetes mellitus (NIDDM).
5.Subjects other than that of Exclusive criteria.
 
 
ExclusionCriteria 
Details  1.Subjects with diabetic complications
2.Subjects with other systemic disorders
3.Subjects of Type 1 Diabetes Mellitus
4.Gestational diabetes
5.Severe chronic disease
6.Neoplasm
7.Other endocrinal disorders
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To know the reduction in the range of
1.Fasting Blood Sugar (FBS)
2.Post Prandial Blood Sugar (PPBS)
3.Fasting Urine Sugar (FUS)
4.Post Prandial Urine Sugar (PPUS)
 		 30 days  
 
Secondary Outcome  
Outcome  TimePoints 
To know the reduction in the Classical signs and symptoms of the Prameha.  60 days 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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 4 
Date of First Enrollment (India)   20/02/2025 
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
Modification(s)  

         Diabetes Mellitus is a major and growing health problem worldwide and an important cause of prolonged ill health and early death. Impaired glucose tolerance and impaired fasting glycemia are risk categories for development of cardiovascular diseases. Diabetes Mellitus is a leading cause for renal failure. Hence the focus of the medical community is on the prevention and treatment of the disease.

           Drawback of conventional medicine starts from the development of resistance and adverse drug reactions leads lack of responsiveness in the wide range of the patient community. Prameha i.e. Type 2 Diabetes Mellitus is a chronic metabolic disorder. Characterised by increase in the Blood glucose level. Due to the abnormal insulin production and impaired insulin utilisation or both. Which leads to over time serious damage to the heart, blood vessels, eyes, kidney and nerves.

         Ayurveda explained Prameha as a set of complex clinical disorders characterised by increased micturition with aetiology involving genetic predisposition as well as improper dietics and sedentary life style. The signs and symptoms described in prameha have much common with diabetes mellites

                             Hence the current study aims to reduce the signs and symptoms of the disease and avoiding further development of the disease and its other complications by regulating the blood glucose level with the help of the medicine

 
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