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CTRI Number  CTRI/2026/02/103629 [Registered on: 11/02/2026] Trial Registered Prospectively
Last Modified On: 10/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To see the clinical effect of Kutaja Asanadi Yoga in the management of Prameha(prediabetes) 
Scientific Title of Study   A randomised controlled clinical study to evaluate the efficacy of Kutaja Asanadi Yoga in the management of Prameha(prediabetes) 
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 Sagar Chilad 
Designation  PG Scholar 
Affiliation  SDMTs AMC Post Graduation Centre Terdal  
Address  OPD Department Of Kayachikitsa First Floor SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Terdal Bagalkot KARNATAKA 587315 India

Bagalkot
KARNATAKA
587315
India 
Phone  8746858802  
Fax    
Email  drsagarchilad@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sukumar Nandigoudar  
Designation  Professor  
Affiliation  SDMTs AMC Post Graduation Centre Terdal  
Address  OPD Department Of Kayachikitsa First Floor SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Terdal Bagalkot KARNATAKA 587315 India

Bagalkot
KARNATAKA
587315
India 
Phone  9986125625  
Fax    
Email  vaidyasukumar@gmail.com   
 
Details of Contact Person
Public Query  
Name  Dr Sagar Chilad 
Designation  PG Scholar 
Affiliation  SDMTs AMC Post Graduation Centre Terdal  
Address  OPD Department Of Kayachikitsa First Floor SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Terdal Bagalkot KARNATAKA 587315 India

Bagalkot
KARNATAKA
587315
India 
Phone  8746858802  
Fax    
Email  drsagarchilad@gmail.com  
 
Source of Monetary or Material Support  
SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar Terdal Karnataka 587315 
 
Primary Sponsor  
Name  Dr Sagar Chilad 
Address  SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Center, Terdal, Bagalkot Karnataka, 587315 
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 Sagar k Chilad  Padma Ayurvedic Hospital And Research Centre   OPD Department Of Kayachikitsa First Floor SDM Trusts Ayurvedic Medical College Danigond Post Graduation Centre Padma Ayurvedic Hospital And Research Centre Dr Siddhant Nagar, Terdal Bagalkot KARNATAKA Bagalkot KARNATAKA
Bagalkot
KARNATAKA 		 8746858802

drsagarchilad@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SDMTs Ayurvedic Medical College And Padma Ayurvedic Hospital 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:R739||Hyperglycemia, unspecified. Ayurveda Condition: PRAMEHA-PURVARUPAM,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Nisha Amalaki Yoga, Reference: Astanga Hridaya. Chikitsa Sthana 12th chapter, Route: Oral, Dosage Form: Churna/ Powder, Dose: 6(g), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information:
2Intervention ArmDrugClassical(1) Medicine Name: Kutaja Asanadi Yoga, Reference: Yogaratnakara: Uttarardha, Prameha Nidan Adhyaya, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 24(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: -
 
Inclusion Criteria  
Age From  21.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Prediabetic Subjects with or without clinical presentation and Fasting Blood Glucose
between 100mg per dl to 125mg per dl With 8 hours of fasting As per ADA guidelines.
2 Subjects with or without family history of diabetes.
3. Known cases or freshly diagnosed cases of Prediabetes.
4. IDRScore by MDRF greater than or equal to 60 out of 100 indicating high risk
5. Subjects aged between 18 to 70 years of either gender.  
 
ExclusionCriteria 
Details  1. Known case of type 1 and type 2 Diabetes Mellitus.
2. Patients already on Antidiabetic Medication
3. Prediabetic patients with co-morbidities which are life threatening or interferes with
the intervention.
4. Pregnancy or lactating women.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Effect of Trial Drug on Improvement in the symptoms of Prameha (Prediabetes)  30th Day , 60th Day 
 
Secondary Outcome  
Outcome  TimePoints 
Saftey of trial drug and Adverse Drug Reaction Aggravation of symptoms of Prameha (Prediabetes)  30th Day , 60th Day 
 
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)   01/03/2026 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Prediabetes is a condition characterized by elevated blood glucose levels below the threshold for a diagnosis of diabetes but associated with a higher risk of developing diabetes with or without clinical symptoms like fatigue, increased thirst, frequent urination, frequent thirst .Alongside Impaired glucose tolerance[140–199 mg/dL] and impaired fasting glucose[110–125 mg/dL] as per World Health Organization are commonly used to define prediabetes. which can be correlated with Prameha. 
According to the principles of Ayurveda sedentary lifestyle, obesity, unrestricted diet are leading cause of Prameha and is explained as one of the Astamahagada with symptoms Madhuryamasya, Swedadikyata, Galatalusosha, karapadadaha, prabhutavilmutrata, trishnakshudhaadikya. If neglected turns to Madhumeha (further complication). Hence Early intervention at Purvaavastha of Prameha i.e prediabetic stage would help to slow progression towards diabetes.
In Contemporary medicine and drug therapy, Metformin is used as first line medicine therapy agent in prediabetes which showed to have side effects like gastrointestinal adverse events, weight loss, B12 deficiency etc. Here is an attempt to evaluate the outcome of Kutaja asanadi yoga which is having properties like kaphapitta shamak, Deepana, Pachana, Lekhana, Kledahara and Pramehahara, which is cost effective with easily available ingredients and its efficacy is compared with control drug Nisha amalaki yoga.
 
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