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CTRI Number  CTRI/2023/09/058064 [Registered on: 26/09/2023] Trial Registered Prospectively
Last Modified On: 13/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Nishatriphala yoga on HbA1c level in Madhumeha (Diabetes Mellitus) 
Scientific Title of Study   A randomised controlled clinical trial to evaluate the effect of Nishatriphala yoga on HbA1c level in the management of Madhumeha w.s.r. to 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 Vijaylaxmi B Hiremath 
Designation  P G Scholar 
Affiliation  Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre 
Address  SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar Terdal 587315 Karnataka

Bagalkot
KARNATAKA
587315
India 
Phone  9901589010  
Fax    
Email  tejsangvi2124@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mahadev S Badiger 
Designation  Professor and HOD 
Affiliation  Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre 
Address  SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar Terdal 587315 Karnataka

Bagalkot
KARNATAKA
587315
India 
Phone  9036701207  
Fax    
Email  drmsb123@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vijaylaxmi B Hiremath 
Designation  PG Scholar 
Affiliation  Sidramappa Danigond Memorial Trusts Ayurvedic Medical College Post Graduation Centre 
Address  SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar Terdal 587315 Karnataka

Bagalkot
KARNATAKA
587315
India 
Phone  9901589010  
Fax    
Email  tejsangvi2124@gmail.com  
 
Source of Monetary or Material Support  
SDM Trusts Ayurvedic Medical College Post Graduation And Research Centre Terdal  
 
Primary Sponsor  
Name  Dr Vijaylaxmi B Hiremath 
Address  SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar Terdal 587315 Karnataka 
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 Vijaylaxmi B Hiremath  Padma Ayurvedic Hospital And Research Centre  OPD Department of Kayachikitsa Ground Floor Padma Ayurvedic Hospital And Research Centre Terdal 587315
Bagalkot
KARNATAKA 		 9901589010

tejsangvi2124@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee For Research On Human Subjects  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
1Comparator ArmDrugClassical(1) Medicine Name: Vidanga rajanyadi kashaya, Reference: Sahasrayoga Purvardha Kashaya prakarana, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Nishatriphala Yoga, Reference: Yogaratnakara Uttarardha Prameha Chikitsa Rogadhikara, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: -), Additional Information: -
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  • Subjects with classical sign and symptoms of Madhumeha and Type-2 Diabetes Mellitus.
• HbA1C level more than 6.5%.
• On-going antidiabetic treatment at least 3 weeks.
• Patient willing to sign and give consent. 
 
ExclusionCriteria 
Details  • Patient of IDDM (Type-1 DM), Juvenile Diabetes and gestational diabetes mellitus will be excluded.
• Diabetic Patient with co-morbidities, which are life threatening or interferes with the intervention.
• Pregnant and Lactating mother will be excluded. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Effect of trail drug over the classical symptoms of Madhumeha and HbA1c level   30 day 60 day 90 day 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of Safety of Drug and Adverse drug reactions
Aggravation of the symptoms of Madhumeha 		 30day, 60day, 90day 
 
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 3 
Date of First Enrollment (India)   01/10/2023 
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="0"
Months="10"
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  
  • Prameha is one of the eight Mahagada. Madhumeha is one of the types of VatajaPrameha involving Ojas as its Dushya, with cardinal symptoms of Prbhuta and Avila Mutrata, Adhika Kshudha, Adhika Trishna and Dourbalya.
  • Madhumeha is corelated with Diabetes Mellitus in contemporary science showing symptoms like polyuria, polydipsia, polyphagia, generalized weakness. It is a metabolic disorder which emerged as an important public health problem globally.
  • HbA1c (Glycated haemoglobin) has been a standard test of long-term average blood glucose control. It is universally accepted that higher the HbA1c are associated with greater risk of complication from type II diabetes.
  • Hence  expected to have effect over glycaemic index and also helping in reducing HbA1c subsequently with reduction in signs and symptoms.
  • Nishatriphala Yoga  is selected to asses it’s effect on HbA1c in the management of Madhumeha.
  • 40 Patients of Madhumeha will be selected, subjects shall be pre-screened. Ayurvedic subjective assement parameters of Madhumeha (Type-2 DM) based on Signs and sympotms like bahumutrata, trishnadhikya, adhika kshudha etc.Objective parameters are assessed by gradings of HbA1c and FBS, PPBS.
  • After study, data will be collected from case report form (CRF) and statistically analyzed by using appropriate parametric and non-parametric tests and results will be obtained. On that basis of results, conclusion will be drawn.
 
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