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 Mellitusâ€
|
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
|
|
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
|
|
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. |