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CTRI Number  CTRI/2024/09/073711 [Registered on: 10/09/2024] Trial Registered Prospectively
Last Modified On: 09/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To see the effect of Ayurvedic formulation alongwith Metformin an allopathic drug in treatment of Madhumeha with reference to Type 2 Diabetes 
Scientific Title of Study   Randomized Controlled Open label Clinical trial to Study add on effect of Triphaladi Kashay alongwith Metformin in management of Madhumeha w.s.r to 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 Unmesh Vikas Deshmukh 
Designation  MD Kayachikitsa Scholar(Ayurveda) 
Affiliation  Dr.VJD Gramin Ayurved Mahavidyalaya,Patur,Akola 
Address  Dr.VJD Gramin Ayurved Mahavidyalaya,near Renuka mata mandir,Patur,Tal-Patur,Dist-Akola Pin-444501 MAHARASHTRA INDIA

Akola
MAHARASHTRA
444501
India 
Phone  8446525624  
Fax    
Email  unmeshdeshmukh1198@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrJayshree Katole 
Designation  Professor and Head of the Department,Kayachikitsa 
Affiliation  Dr.VJD Gramin Ayurved Mahavidyalaya 
Address  OPD NO 3 Department of Kayachikitsa,Dr.VJD Gramin Ayurved Mahavidyalaya,near Renuka mata mandir,Patur,Tal-Patur,Dist-Akola Pin-444501 MAHARASHTRA INDIA

Akola
MAHARASHTRA
444501
India 
Phone  9423847608  
Fax    
Email  drjrkatole@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DrJayshree Katole 
Designation  Professor and Head of the Department,Kayachikitsa 
Affiliation  Dr.VJD Gramin Ayurved Mahavidyalaya 
Address  OPD NO 3,Department of Kayachikitsa,Dr.VJD Gramin Ayurved Mahavidyalaya,near Renuka mata mandir,Patur,Tal-Patur,Dist-Akola Pin-444501 MAHARASHTRA INDIA

Akola
MAHARASHTRA
444501
India 
Phone  9423847608  
Fax    
Email  drjrkatole@gmail.com  
 
Source of Monetary or Material Support  
Department of Kayachikitsa,Dr VJD Gramin Ayurved Mahavidyalaya,Patur,Dist-Akola,Maharashtra,India Pin code -444501 
 
Primary Sponsor  
Name  Dr.VJD Gramin Ayurved Mahavidyalaya 
Address  Dr.VJD Gramin Ayurved Mahavidyalaya,near Renuka mata mandir,Patur,Tal-Patur,Dist-Akola,Maharashtra,India Pin-444501 
Type of Sponsor  Research institution and hospital 
 
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 Unmesh Vikas Deshmukh  Dr.VJD Gramin Ayurved Mahavidyalaya  OPD no.3 , Department of Kayachikitsa,Dr.VJD Gramin Ayurved Mahavidyalaya,near Renuka mata mandir,Patur,Tal-Patur,Dist-Akola
Akola
MAHARASHTRA 
8446525624

unmeshdeshmukh1198@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,DR VJD Gramin Ayurved Mahavidyalaya,Patur, Akola   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 ArmDrugClassical(1) Medicine Name: Triphaladi Kashay, Reference: Bhaishajya Ratnavali Prameha Chikitsa 37/7, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: -Madhu), Additional Information: -Triphaladi Kashay 30 ml bd alongwith Tab Metformin 500 mg od
2Comparator Arm (Non Ayurveda)-MetforminTab Metformin 500 mg od
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Patient willing for clinical trial and written consent.
2. Age group from 30 to 70 yrs.
3. Patients with newly diagnosed as well as known case of type 2 diabetes mellitus already taking Tab. Metformin 500 mg only.
4. The patients having symptoms of prabhutmutrata, trushnadikya, kshudhadikya, daurbalya, alasya .
5.Blood Sugar Level (Fasting-120 to 159 mg/dl)
(Post prandial-160 to 250 mg/dl)
6.Hba1c 6.5 to 9
7. Patients without any complication of madhumeha (type 2 D.M.) or without any other systemic disorder. 
 
ExclusionCriteria 
Details  1. Patients not willing for clinical trial and written consent.
2. Sahaj and jatha janya madhumeha or patients with type 1 diabetes mellitus
3. Patients on insulin therapy or Steroid Therapy.
4. Patients having blood sugar more than 250mg/dl.
5.Subjects under any other oral hypoglycaemic therapy other than Tab.Metformin 500 mg
6. Patients having complication of madhumeha or any other systemic disorder like renal disorder, heart disease, Neurological,psychological disorder and Carcinoma.
7.Pregnant and Lactating Women 
 
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   Open Label 
Primary Outcome  
Outcome  TimePoints 
Symptoms like1. Prabhutmutrata
2. Trushnadikya
3. Kshudhadhikya
4. Daurbalya
5.Alasya will be decreased and Control over Madhumeha with reference to Type 2 Diabetes Mellitus 
30 days,60 days,90 days after starting treatmemt 
 
Secondary Outcome  
Outcome  TimePoints 
Decrease in Symptoms of Madhumeha and Control over BSL  18 Months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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   N/A 
Date of First Enrollment (India)   20/09/2024 
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  
Ayurveda is a natural health care system that originated in India since the beginning of civilization. It is described by Acharya Charak that to achieve purushartha chatushtaya, Arogya is necessary. Ayurveda strongly emphasize on preventive and promotive aspects of health rather than curative. The concepts of Dincharya, Ritucharya, Sadvritta and Achara Rasayana along with guidelines for healthy diet and lifestyle is well established in Ayurveda, but in current scenario, hardly any one follows it as a result ,there is tremendous rise in lifestyle disorders as pandemics, Diabetes being most menacing among them. Diabetes is fourth leading cause of global death by disease. Type 2 DM is responsible for approximately 90% of cases. Therefore today’s India is called nation of DM.
Madhumeha "Richman’s disease", since Vedic period, is familiar to mankind. Madhumeha is a disease in which mutra (Urine) of the patient attains similar property like those of madhu (Honey). It is documented as one among the twenty obstinate urinary disorders i.e. Prameha. It is also explained that, when the other Prameha are left untreated, this lead to the condition called Madhumeha. So Madhumeha can also be considered as an advanced condition or stage of Prameha.
Diabetes Mellitus is a chronic disorder of carbohydrate metabolism, marked by hyperglycemia and glycosuria and resulting from inadequate production or use of insulin. Traditionally, Madhumeha can be equated with diabetes mellitus, as many similarities in view of their causative factors, pathogenesis, signs and symptoms, classification, complications and treatment has been found.
Diabetes mellitus is a clinical syndrome characterised by hyperglycemia caused by an absolute or relative deficiency of insulin & insulin resistance lack of insulin, whether absolute or relative, affects the metabolism of carbohydrates. Type II diabetes mellitus has become a global epidemic. Modern medicines, despite offering a variety of effective treatment options can have several adverse effects.
Diabetes Mellitus is classified into 2 types. 1. Type I (IDDM/juvenile diabetes) 2. Type II (NIDDM/adult onset diabetes) With regard to diabetes mellitus, Sahaj prameha and kulaj prameha correlate with type I diabetes and apathyanimittaja prameha correlates with type II diabetes. According to Ayurveda Prameha is Included in one of the Mahagadas. In prameha maximum no. of strotas, all 7 Dhatus & ojas get involved & prameha shows group of many symptoms due to this condition of patient goes on deteriorating day by day. The Ayurvedic management of Diabetes aims not only to achieve a strict glycemic control but also to treat the main & root cause of disease. Many drugs & formulae have prescribed for internal & external use in Ayurved samhitas, one of which is “Triphaladi Kashay” .This thesis is an attempt to study the add on effect of “Triphaladi Kashay alongwith Metformin” in Madhumeha & improve the personal & social life of a patient, it is an effort of scholar to observe the add on effect of Triphaladi kashay alongwith Metformin in Madhumeha (NIDDM)

 
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