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CTRI Number  CTRI/2025/03/082850 [Registered on: 19/03/2025] Trial Registered Prospectively
Last Modified On: 12/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Comparative clinical study on the effect of kalingakadi and Patoladi ghanavati on Metabolic Health and Blood sugar Level 
Scientific Title of Study   Comparative clinical study to evaluate the efficacy of kalingakadi and patoladi ghanavati on rasa dhatvagni and rakta dhatvagni and raised blood sugar levels 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Patil Ankit Sanjay  
Designation  PG Scholar 
Affiliation  National Institute of Ayurveda, Jaipur 
Address  Department of Samhita and Maulik Siddhanta, National Institute of Ayurveda, Amer Road, Jaipur, Rajasthan

Jaipur
RAJASTHAN
302002
India 
Phone  9689469704  
Fax    
Email  ankitpatil976@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Vidyadhish Anantrao Kashikar  
Designation  Assistant Professor 
Affiliation  National Institute of Ayurveda, Jaipur 
Address  Department of Samhita and Maulik Siddhanta, National Institute of Ayurveda, Amer Road, Jaipur, Rajasthan

Jaipur
RAJASTHAN
302002
India 
Phone  9423346706  
Fax    
Email  vidyadhish.samhita@nia.edu.in  
 
Details of Contact Person
Public Query  
Name  Patil Ankit Sanjay 
Designation  PG Scholar 
Affiliation  National Institute of Ayurveda, Jaipur 
Address  Department of Samhita and Maulik Siddhanta, National Institute of Ayurveda, Amer Road, Jaipur, Rajasthan

Jaipur
RAJASTHAN
302002
India 
Phone  9689469704  
Fax    
Email  vidyadhish.samhita@nia.edu.in  
 
Source of Monetary or Material Support  
National Institute of Ayurveda, Jaipur, Rajasthan, India 302002 
 
Primary Sponsor  
Name  National Institute of Ayurveda Jaipur 
Address  National Institute of Ayurveda, Madhav Vilas Palace, Amer road, Jaipur, Rajasthan, India 302002 
Type of Sponsor  Research institution and hospital 
 
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 Patil Ankit Sanjay  NATIONAL INSTITUTE OF AYURVEDA  Room no. 103, Department of Samhita and Maulik Siddhanta, , Amer road, Jaipur, Rajasthan, India 302002
Jaipur
RAJASTHAN 		 9689469704

ankitpatil976@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, National Institute of Ayurveda  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
1Comparator ArmDrugClassical(1) Medicine Name: PATOLADI GHANAVATI, Reference: CHARAK CHIKITSA STHANA 03 JVARA ADHYAYA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: KOSHNA JALA), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Kalingakadi Ghanavati, Reference: Charak Chikitsa Sthana 03, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: koshna jala), Additional Information: -
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of either sex in the age group of 18-60 year
Patient in Diabetic and Prediabetic Group
Diabetics
FBS 126 to 180 mg/dl
PPBS 200 to 250 mg/dl

Pre-Diabetics
FBS 100 to 125 mg/dl
PPBS 140 to 199 mg/dl
 
 
ExclusionCriteria 
Details  Patient having Diabetes mellitus Type-1 [IDDM]
Patients having any malignancies, any other serious illness
Pregnant and lactating women
Benign prostatic hyperplasia
Diabetes insipidus
Pelvic organ prolapse  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in FBS, PPBS, HbA1C and effect on rasagni and raktagni.   Baseline and 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in, Urine R/M and BMI  0, 4 WEEK, 8 WEEK 
 
Target Sample Size   Total Sample Size="104"
Sample Size from India="104" 
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 
Date of First Enrollment (India)   21/05/2025 
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   Bahumutrata is Vyadhiprabodhaka in prameha. Although majority of cases of raised blood sugar level do not clearly manifest these symptoms. Raised Blood sugar levels can be considered as effect of Dusta Rasa or Rakta due to visama Rasagni, Raktagni or any Dhatvagni. If Vitiation in Dhatvagni is corrected, it may alleviate the dusti in the dhatu, thus correcting the dusti in Prameha which will impact blood sugar level. 
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