| CTRI Number |
CTRI/2025/03/081737 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
01/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Nutraceutical |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical trial on blood glucose level in diabetic patients. |
|
Scientific Title of Study
|
A Prospective, open-label clinical study to evaluate the safety and efficacy of Auretics Sugar Management Spray in stabilizing blood glucose levels in Diabetic patients. |
| 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 Vishnu Hayagreev |
| Designation |
Principal Investigator |
| Affiliation |
Shree Maruthi Hospital |
| Address |
Shree Maruthi Hospital
Dept.of Medicine Room No 1, Ground Floor
No 67 Link Road, Sheshadripuram
Bengaluru
Bangalore
KARNATAKA
560020
India |
| Phone |
9448144151 |
| Fax |
|
| Email |
amruthvishnu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arjun Gupta |
| Designation |
Director |
| Affiliation |
Auretics Limited |
| Address |
Plot No 190,Old Block
Near LIC Colony, Mangal Bazar Road, Dilshad Garden
New Delhi
DELHI
110095
India |
| Phone |
9999112999 |
| Fax |
|
| Email |
arjun@auretics.com |
|
Details of Contact Person
Public Query
|
| Name |
Arjun Gupta |
| Designation |
Director |
| Affiliation |
Auretics Limited |
| Address |
Plot No 190,Old Block
Near LIC Colony, Mangal Bazar Road, Dilshad Garden
DELHI
110095
India |
| Phone |
9999112999 |
| Fax |
|
| Email |
arjun@auretics.com |
|
|
Source of Monetary or Material Support
|
| Auretics Limited
Plot No 190, Old Block, Near LIC Colony, Mangal Bazar Road, Dilshad Garden, New Delhi 110095 |
|
|
Primary Sponsor
|
| Name |
Auretics Limited |
| Address |
Plot No 190, Old Block, Near LIC Colony, Mangal Bazar Road, Dilshad Garden, New Delhi 110095 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Vishnu Hayagreev |
Shree Maruti Hospital |
Shree Maruthi Hospital
Dept. of Medicine, Room No 1 Ground Floor
#67 Link Road, Sheshadripuram,
Bengaluru 560020
Bangalore
KARNATAKA |
9448144151
amruthvishnu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pranav Diabetic Center Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E089||Diabetes mellitus due to underlying condition without complications. Ayurveda Condition: MADHUMEHAH/KSHAUDRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Sug Rodhi, Reference: NA, Route: Topical, Dosage Form: Taila, Dose: 10(ml), Frequency: tds, Bhaishajya Kal: Muhurmuhu, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: -none |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subject Between 30 years to 60 years of both genders.
2. Diabetic subjects on anti diabetic medication.
3. Subject who are hypertensive
4. Subject free from infection, cancer and other diseases
5. Subject willing to give written Informed Consent
6.FAsting Blood Glucose level between 110 mg/dl to 250 mg/dl
7.Post Parandial Blood Sugar level between 140 mg/dl to 350 mg/dl
|
|
| ExclusionCriteria |
| Details |
1.Subjects with diabetes mellitus along with other comorbid conditions.
2.Pregnant or lactating women
3. Women of childbearing potential who do not take adequate contraceptive protection
4.History of hypersensitivity to the metformin or to drug with similar chemical structure
5.History of any severe systemic disease
6.Patients with uncontrolled hypertension
7.History of stroke, cancer, acute illness
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary out Come:
1.To evaluate the efficacy of Auretics Sugar Management Spray in stabilizing Blood Sugar in Diabetic patients.
2. Decrease in Blood Sugar Level- Fasting blood sugar (FBS), Post Prandial Blood Sugar (PPBS) Glycated hemoglobin (HbA1c) and Urine Sugar from Day 0 to Day 90 |
Evaluation from baseline to day 30, day 60 and day 90
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Outcome:
To evaluate the safety and consumer acceptance of Auretics Sugar Management Spray in stabilizing blood glucose levels in Diabetic patients through feedback questionnaires
|
Baseline and Day 90 |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
17/03/2025 |
| 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="0"
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 (DM) has become a significant global health issue, attracting increasing attention due to its widespread impact. It is anticipated to remain a major public health challenge, often leading to severe complications. India ranks among the top five countries with the highest prevalence of diabetes. In Ayurveda diabetes is called as Prameha. There are twenty types of prameha: 1) Kaphaja Prameha – which includes Ten types – early stage Overweight with mild hyperglycaemia. - Polyuria/ glycosuria 2) Pittaja prameha – which includes six types – Acute stage Loss of weight. - Hyperglycaemia and glycosuria - urinary tract infection 3) Vataja Prameha – which includes four types – Chronic stage. • Severe hyperglycaemia with glycosuria (Chronic diabetes) • Nephropathy neuropathy - Retinopathy – Gangrene
Auretics Sugar Management Spray helps reduce increased blood sugar and increase insulin levels after meals, helps lower fasting blood glucose levels by enhancing the insulin activity and sensitivity and helps strengthen pancreas and increases insulin secretion, making the body more responsive to insulin. Our formulation Auretics Sugar Management Spray contains all active natural ingredients. These natural ingredients in common have capacity to lower the blood sugar levels. Also this product is applied through external route that is topical absorption. Transdermal drug delivery systems have been explored for diabetes management, offering a non- invasive alternative to injections. These systems deliver medications through the skin to help regulate blood sugar levels. |