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CTRI Number  CTRI/2025/12/098627 [Registered on: 08/12/2025] Trial Registered Prospectively
Last Modified On: 05/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Other (Specify) [Placebo]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Effect Of Ayurveda Drug In Type 2 Diabetes Mellitus 
Scientific Title of Study   Add On Efficacy Of Nishakatakadi Kashayam Capsule In Type 2 Diabetes Mellitus A Randomized Double Blind Placebo Controlled Clinical Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Bhivate Sneha Sanjay 
Designation  PG Scholar 
Affiliation  KAHERs Shri BMK Ayurveda Mahavidyalaya Post Graduate Studies And Research Centre Shahapur Belagavi 
Address  Department Of Kayachikitsa KAHERs Shri BMK Ayurveda Mahavidyalaya Post Graduate Studies And Research Centre Shahapur Belagavi Belgaum KARNATAKA 590003 India

Belgaum
KARNATAKA
590003
India 
Phone  9511959001  
Fax    
Email  snehabhivate27@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Suketha Kumari 
Designation  Professor 
Affiliation  KAHERs Shri BMK Ayurveda Mahavidyalaya Post Graduate Studies And Research Centre Shahapur Belagavi 
Address  Department Of Kayachikitsa KAHERs Shri BMK Ayurveda Mahavidyalaya Post Graduate Studies And Research Centre Shahapur Belagavi Belgaum KARNATAKA 590003 India

Belgaum
KARNATAKA
590003
India 
Phone  9483637757  
Fax    
Email  sukethashetty411@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Suketha Kumari 
Designation  Professor 
Affiliation  KAHERs Shri BMK Ayurveda Mahavidyalaya Post Graduate Studies And Research Centre Shahapur Belagavi 
Address  Department Of Kayachikitsa KAHERs Shri BMK Ayurveda Mahavidyalaya Post Graduate Studies And Research Centre Shahapur Belagavi Belgaum KARNATAKA 590003 India

Belgaum
KARNATAKA
590003
India 
Phone  9483637757  
Fax    
Email  sukethashetty411@gmail.com  
 
Source of Monetary or Material Support  
KAHERs Shri BMK Ayurveda Mahavidyalaya Post Graduate Studies And Research Centre Shahapur Belagavi Karnataka India 590003 
 
Primary Sponsor  
Name  Dr Bhivate Sneha Sanjay 
Address  KAHERs Shri BMK Ayurveda Mahavidyalaya Post Graduate Studies And Research Centre Shahapur Belagavi 
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 Bhivate Sneha Sanjay  KLE Ayurveda Hospital And Medical Research Centre  OPD No 6 Department Of Kayachikitsa KLE Ayurveda Hospital And Medical Research Centre Shahapur Belagavi Belgaum KARNATAKA
Belgaum
KARNATAKA 		 9511959001

snehabhivate27@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee For Research On Human Subjects KAHERS Shri B M Kankanawadi Ayurveda Mahavidyalaya And KLE Ayurveda Hospital Shahapur Belagavi  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
1Intervention ArmDrugOther than Classical(1) Medicine Name: Nishakatakadi Kashayam Capsule, Reference: NA, Route: Oral, Dosage Form: Capsules, Dose: 1000(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: Warm Water), Additional Information: Standard Diabetes Care [Combination of metformin with secondary antidiabetic agents] Nutritional and lifestyle recommendations
2Comparator Arm (Non Ayurveda)-PlaceboWheat flour 500 mg 2 capsules thrice a day with warm water after food Standard Diabetes Care [Combination of metformin with secondary antidiabetic agents] Nutritional and lifestyle recommendations 90 days
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Known subject of Type 2 Diabetes mellitus having HbA1c more than 6.5% with established clinical diagnosis of Type 2 Diabetes mellitus for at least 3 months prior to screening period and are on standard diabetic care
Both gender of Age group between 20 to 70 years
Subject with a normal serum creatinine level less than 1.5 mg /dl
Subject who submits written informed consent
 
 
ExclusionCriteria 
Details  Subjects with Type 1 Diabetes Mellitus.
Subjects being treated for Type 2 Diabetes Mellitus with insulin.
Subjects with established diagnosis of CAD or any other clinically significant cardiovascular disease.
Uncontrolled hypertension.
Subjects with established cases of cerebrovascular accidents such as stroke etc.
Subjects with any complications of Type 2 Diabetes Mellitus such as retinopathy, neuropathy, nephropathy etc.
Pregnant and lactating women.
Subjects with evidence of malignancy
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
HbA1c( Glycated hemoglobin A1c)  Baseline and 90th Day. 
 
Secondary Outcome  
Outcome  TimePoints 
FBS(Fasting blood sugar), PPBS(Post prandial blood Sugar), Triglycerides, Triglycerides Glucose Index, Serum Creatinine   Baseline and 90th Day. 
RBS(Random blood sugar), Urine Sugar, SF-36 QoL(Short Form 36 Quality Of Life), BMI(Body Mass Index) , Weight, Waist Circumference, prameha purva roopa and roopa parameters  Baseline, 30th, 60th and 90th Day 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 2/ Phase 3 
Date of First Enrollment (India)   15/01/2026 
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   Type 2 Diabetes Mellitus is a metabolic disorder that occurs due to reduced response of body cells to insulin and a gradual decline in insulin secretion. It leads to high blood sugar levels and long term complications affecting the eyes, kidneys, nerves and heart. Although many modern medicines are available, they may cause side effects and do not always provide optimal control. Yoga, diet and Ayurveda based integrated approaches have shown helpful effects in earlier studies. However, there is limited scientific evidence on the independent effect of Ayurveda drugs used alone in Type 2 Diabetes. This study aims to evaluate the effectiveness of an Ayurveda drug as a standalone treatment in patients with Type 2 Diabetes Mellitus. 
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