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CTRI Number  CTRI/2026/01/102046 [Registered on: 27/01/2026] Trial Registered Prospectively
Last Modified On: 23/01/2026
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   Effect of the Niruryadi Gulika in Type 2 Diabetes Mellitus. 
Scientific Title of Study   An Open Labelled Active controlled Randomized Comparative Clinical Trial to Evaluate the Adjuvant Effect of Niruryadi Gulika in the Management of Type 2 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 Nikhil Thakur 
Designation  PG SCHOLAR 
Affiliation  Parul Institute of Ayurved 
Address  OPD no 116 Department of Kayachikitsa Parul Ayurved Hospital Parul University AP Limda Tal Waghodiya Vadodara GUJARAT

Vadodara
GUJARAT
391760
India 
Phone  8219779233  
Fax    
Email  tnikhil1998@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Haresh Soni  
Designation  Professor and HOD 
Affiliation  Parul Institute of Ayurved 
Address  OPD no 116 Department of Kayachikitsa Parul Ayurved Hospital Parul University AP Limda Tal Waghodiya Vadodara GUJARAT

Vadodara
GUJARAT
391760
India 
Phone  7878374848  
Fax    
Email  drhareshsoni71@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Haresh Soni  
Designation  Professor and HOD 
Affiliation  Parul Institute of Ayurved 
Address  OPD no 116 Department of Kayachikitsa Parul Ayurved Hospital Parul University AP Limda Tal Waghodiya Vadodara GUJARAT

Vadodara
GUJARAT
391760
India 
Phone  7878374848  
Fax    
Email  drhareshsoni71@gmail.com  
 
Source of Monetary or Material Support  
Parul Institute of Ayurved,Parul University,AP Limda,TAL Waghodia,Vadodara,Gujrat,India,391760 
 
Primary Sponsor  
Name  Parul Institute of Ayurved 
Address  Faculty of Ayurved, Parul University, AP Limda, TAL Waghodia, District Vadodara, Gujrat, India 391760 
Type of Sponsor  Private medical college 
 
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 Nikhil Thakur  Parul Ayurved Hospital  OPD no 116 Department of Kayachikitsa Parul Ayurved Hospital Parul University AP Limda Tal Waghodiya Vadodara GUJARAT
Vadodara
GUJARAT 
8219779233

tnikhil1998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PARUL INSTITUTE OF AYURVED  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:R730||Abnormal glucose. Ayurveda Condition: PRAMEHAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugOther than Classical(1) Medicine Name: Niruryadi Gulika , Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 1000(mg), Frequency: tds, Bhaishajya Kal: Adhobhakta, Duration: 90 Days, anupAna/sahapAna: Yes(details: water), Additional Information: Niruryadi Gulika 2 tablets each of 500 mg TID given along with Metformin 500 mg and Glimepiride 1 mg OD.
2Comparator Arm (Non Ayurveda)-Metformin and GlimepirideRoute: Oral, Dosage form: tablets, Dose: 500 mg and 1 mg combination, Frequency: OD, Bhaishajya kal: After Food, Duration: 90 days, Anupana: water
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Known case of Type 2 Diabetes Mellitus.
Patients willing to give written informed consent.
Patients with FBS more than 126 mg per dl to 300 mg per dl and PP2BS more than 140 mg per dl to 400 mg per dl (both inclusive)
Patients with HbA1C levels between 6.5 to 10 mg percentage.
Patients with type 2 diabetes mellitus who are on stable doses of Metformin and
Glimepiride therapy.  
 
ExclusionCriteria 
Details  Patients showing acute complications and chronic complications like neuropathy,nephropathy, retinopathy.
Patients with Diabetes Mellitus Type I.
Lactating and Pregnant Women.
Patients with other systemic diseases like IHD,uncontrolled hypertension.
Known cases of immune compromised condition like HIV.
Known cases of active infectious diseases.
Patients taking any antidiabetic medications other than Metformin and Glimepiride . 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To evaluate the adjuvant effect of Niruryadi Gulika in management of Type 2 Diabetes Mellitus on the basis of fasting blood sugar level, post parandial blood sugar level and HbA1C.
 
HbA1C at Baseline and 90th day
FBS at Baseline, 30th day, 60th day, and 90th day
PP2BS at Baseline, 30th day, 60th day, and 90th day 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the adjuvant effect of Niruryadi Gulika in management of Type 2 Diabetes Mellitus on the basis of weight, BMI and subjective parameters.
 
Baseline, 15th day, 30th day, 45th day, 60th day, 75th day, and 90th day. 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   21/02/2026 
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 major global and national health concern, with India bearing a significant disease burden. In Ayurveda, the condition can be correlated with Prameha, which is described as a chronic metabolic disorder with multifactorial etiology. Despite the availability of conventional antidiabetic drugs such as Metformin and Glimepiride, long-term therapy is often associated with adverse effects, limited metabolic correction, and reduced patient compliance. Hence, there is a growing need to evaluate safe and effective adjuvant therapies.Niruryadi Gulika is a ayurvedic formulation traditionally indicated in the management of Prameha. Experimental studies have demonstrated its antidiabetic, antioxidant, and anti-inflammatory potential; however, systematic clinical evaluation in human subjects is limited.The present study is an open-label, randomized, active-controlled comparative clinical trial designed to evaluate the adjuvant effect of Niruryadi Gulika  along with standard antidiabetic therapy (Metformin and Glimepiride) in patients with Type 2 Diabetes Mellitus. A total of 60 eligible patients will be randomly allocated into two groups: the trial group receiving Niruryadi Gulika in addition to standard treatment, and the control group receiving standard treatment alone, for a duration of 90 days.The efficacy of the intervention will be assessed using objective parameters such as fasting blood sugar, post prandial blood sugar, HbA1c, body weight, and BMI, along with subjective symptoms of Prameha. Safety and tolerability will also be monitored throughout the study. The study aims to generate clinical evidence regarding the role of Niruryadi Gulika as an effective and safe adjuvant therapy in the management of Type 2 Diabetes Mellitus.

 
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