| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:R730||Abnormal glucose. Ayurveda Condition: PRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other 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. | | 2 | Comparator Arm (Non Ayurveda) | | - | Metformin and Glimepiride | Route: 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. |