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CTRI Number  CTRI/2020/06/026223 [Registered on: 29/06/2020] Trial Registered Prospectively
Last Modified On: 19/06/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Diagnostic
Screening 
Study Design  Other 
Public Title of Study   To study the combined effect of Panchakarma and Oral medicine in the management of in Type 2 Diabetes Mellitus 
Scientific Title of Study   “An Open Clinical Study To Evaluate the Combined Effect of Udvartana, Panchatikta Panchaprasrutika Basti and Nishamalaki Yoga in the Management of Sthoola Madhumeha with special reference to Type II Diabetes Mellitus”  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prakash V Naraboli 
Designation  Associate Professor 
Affiliation  BVVS Ayurved Medical College and Hospital, Bagalkot 
Address  Dept of panchakarma, BVVS Ayurved Medical College and Hospital, BVVS Campus, Bagalkot
Dept of panchakarma,BVVS Ayurved Medical College and Hospital, BVVS Campus, Bagalkot
Bagalkot
KARNATAKA
587101
India 
Phone  8867175234  
Fax  08354223280  
Email  ayushprakash11@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr M M Salimath 
Designation  Principal 
Affiliation  BVVS Ayurved Medical College and Hospital, Bagalkot 
Address  BVVS Ayurved Medical College and Hospital, BVVS Campus, Bagalkot
Dept of panchakarma, BVVS Ayurved Medical College and Hospital, BVVS Campus, Bagalkot
Bagalkot
KARNATAKA
587101
India 
Phone  9845010950  
Fax  08354223280  
Email  dr_mahantesh@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Prakash V Naraboli 
Designation  Associate Professor 
Affiliation  BVVS Ayurved Medical College and Hospital, Bagalkot 
Address  BVVS Ayurved Medical College and Hospital, BVVS Campus, Bagalkot
BVVS Ayurved Medical College and Hospital, BVVS Campus, Bagalkot
Bagalkot
KARNATAKA
587101
India 
Phone  8867175234  
Fax  08354223280  
Email  ayushprakash11@gmail.com  
 
Source of Monetary or Material Support  
BVVS Ayurved Medical College and Hospital, BVVS Campus, Raichur road, Bagalkot 587101 
 
Primary Sponsor  
Name  Dr Prakash V Naraboli 
Address  BVVS Ayurved Medical College and Hospital, BVVS Campus, Bagalkot  
Type of Sponsor  Other [Others] 
 
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 Prakash V Naraboli  BVVS Ayurved Medical College and Hospital  BVVS Ayurved Medical College and Hospital, BVVS Campus, Bagalkot
Bagalkot
KARNATAKA 
8867175234
08354223280
ayushprakash11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BVVS Ayurved Medical College and Hospital, Bagalkot  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Sthoola Madhumeha and Type 2 Diabetes Mellitus 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Dr Prakash V Naraboli  Udvartana Churna - 300gms 8 days, Panchatikta Panchaprasrutika Basti- 450ml 8 days, Nishamalaki Yoga - 500mg bd, 60 days  
Comparator Agent  Panchatikta Panchaprasrutika Basti Nishamalaki Yoga Udvaratana Churna   Udvartana Churna - 300gms 8 days, Panchatikta Panchaprasrutika Basti- 450ml 8 days, Nishamalaki Yoga - 500mg bd, 60 days  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients present with classical signs & symptoms of Sthoola Madhumeha (Type II Diabetes Mellitus) of 6 months and FBS ranging between 120mg/dl to 180mg/dl and PPBS ranging between 160mg/dl to 300mg/dl.
2. Patients between the age group of 40 to 60 years.
3. Patients having Sthoola Madhumeha and BMI > 30kg/m2
4. Patients irrespective of religion, sex, socio-economic status, occupation etc.
5. Patients who are fit for Udvartana and Basti.
6. Patients who are willing to sign the informed consent.
 
 
ExclusionCriteria 
Details  1. Patients with diagnosed cases of Sahaja and Dhatukshayajanya Sthoola Madhumeha.
2. Patients of Type II Diabetes Mellitus under Insulin treatment and anti diabetic medicines.
3. Patients associated with any Endocrine metabolic disorders and complications.
4. Pregnancy and Lactation.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The combined effect of shodhana karma, Bahirparimarjana chikitsa with Shamanaushadi yoga.  60 days 
 
Secondary Outcome  
Outcome  TimePoints 
Hence this study is aimed to Evaluate the Combined Efficacy of Udvartana, Panchatikta Panchaprasrutika Basti and Nishamalaki Yoga in the management of Sthoola Madhumeha with special reference to Type II Diabetes Mellitus. Keeping the above protocol in mind, here in an effort is made for holistic approach towards Sthoola Madhumeha by evaluating the combined effect of shodhana karma, Bahirparimarjana chikitsa with Shamanaushadi yoga  4 weeks 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   01/08/2020 
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="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Madhumeha is one among the Vataja Prameha that has been considered as Mahagada1. Sthoola Madhumeha is Tridoshajanya, Atisantarpanajanya, Keldaudbhajanya Vyadhi. It is Yapya vyadhi because of Saptadushya and Apara ojus involved2,3,4.

Sthoola Madhumeha is having extensive etiological factors like improper food habits, genetic, life style etc.. Sthoola Madhumeha is of two types viz.. Avaranajanya and Dhatu kshayajanya Sthoola Madhumeha5,6,7. On the basis of Nidana Panchaka, Avaranjanya Sthoola Madhumeha can be corelated to Non Insulin Dependent Diabetes Mellitus (NIDDM)8,9

Diabetes Mellitus has emerged as a global health hazard and is having tremendous socio-economic impact to the individual as well as society as awhole. According to international diabetic federation (IDF) in the year 2014, worldwide about 387 million people were afflicted with Diabetes, the majority of which are aged between 40 and 59, and 80% of them live in low and middle income countries. According to a study carried out in the year 2013 by the Indian council of medical research, India has 62.4 million people with Diabetes, out of which 90% have Type II Diabetes Mellitus10,11.

Type II Diabetes Mellitus is a heterogeneous disorder with varying prevalence among different ethnic groups. The pathophysiology of T2DM is characterized by peripheral insulin resistance, impaired regulation of hepatic glucose production and declining β-cell function, eventually leading to β-cell failure12,13.

As Atisantarpana is pradhana nidana for Sthoola Madhumeha, Apatarpana chikitsa is pradhana chikitsa siddhanta which includes Vamana, Virechana, Basti, Shamanaushadis and Rasayana. Udvartana, Abhyanga, Swedana, Seka and many Bahirparimarjana chikitsa are few contemporary treatment modalities for Sthoola Madhumeha14,15,16.

Udvartana having qualities like Rukshana, Lekhana, Kledahara, hence it is considered as best line of treatment for Sthoola Madhumeha17,18.

            Panchatikta Panchaprasrutika Basti helps to manage impaired metabolic condition by impacting equilibrium state of dosha, nourishing the dhatu and maintain thereby blood sugar level19,20,21. 

Nishamalaki Yoga with its gunas laghu, ruksha, tikta rasa, Usna veerya as well as Rasayana effect helps to treat Sthoola Madhumeha22,23. Keeping the above protocol in mind, here in an effort is made for holistic approach towards Sthoola Madhumeha by evaluating the combined effect of shodhana karma, Bahirparimarjana chikitsa with Shamanaushadi yoga.

Hence this study is aimed to Evaluate the Combined Efficacy of Udvartana, Panchatikta Panchaprasrutika Basti and Nishamalaki Yoga in the management of Sthoola Madhumeha with special reference to Type II Diabetes Mellitus.

 
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