| CTRI Number |
CTRI/2025/11/098193 [Registered on: 28/11/2025] Trial Registered Prospectively |
| Last Modified On: |
27/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Efficacy and safety of AS JEL in type II diabetic patients. |
|
Scientific Title of Study
|
A randomized,open-label,two-group, parallel study to evaluate the efficacy and safety of AS GEL in type II diabetic patients. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 21PR02141-008 , Version 1.0, Date:15 Sep 2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Venkatesh S |
| Designation |
Consultant Doctor |
| Affiliation |
Vagus Super Speciality Hospital Pvt.Ltd. |
| Address |
Department of General Medicine, Room No-4, 6-8,18th Cross,4th main,Malleswaram west.
Bangalore
KARNATAKA
560055
India |
| Phone |
9738226474 |
| Fax |
|
| Email |
venkateshsmysore7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhargav Bhongiri |
| Designation |
Head Medical Writer |
| Affiliation |
Syncorp Health Pvt. Ltd. |
| Address |
No.6,3rd Floor, second Main Road, sarvobhaogam Nagar, Arekere.
Bangalore
KARNATAKA
560076
India |
| Phone |
9000518175 |
| Fax |
|
| Email |
bhargav.b@syncorphealth.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhargav Bhongiri |
| Designation |
Head Medical Writer |
| Affiliation |
Syncorp Health Pvt. Ltd. |
| Address |
No.6,3rd Floor, second Main Road, sarvobhaogam Nagar, Arekere.
Bangalore
KARNATAKA
560076
India |
| Phone |
9000518175 |
| Fax |
|
| Email |
bhargav.b@syncorphealth.com |
|
|
Source of Monetary or Material Support
|
| Vagus Super Specialty Hospital,No 6-8 18th Cross,4th main,Malleshwaram, Bangalore, Karnataka, India, 560055 |
|
|
Primary Sponsor
|
| Name |
PR Nine Co., Ltd. |
| Address |
6 Soi Wachiratham Sathit 51,Bang Chak, Phra Khanong,Bangkok 10260,Thailand |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Santosh Saklecha |
Santosh Hospital |
6/1 3f, No 6/1, Near Coals Park, Promenade Road, Pulikeshi Nagar, Frazer Town- 560005
Bangalore
KARNATAKA |
9014308214
ssaklecha@gmail.com |
| Dr Venkatesh S |
Vagus Super Speciality Hospital Pvt.Ltd |
Department of General Medicine, Room No-4, 6-8, 18th Cross,4th main, Near Margosa Road BMTC Bus stand, Malleswaram west.
Bangalore
KARNATAKA |
81519 94080
venkateshsmysore7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Santosh Hospital-Institutional Ethics Committee |
Submittted/Under Review |
| Vagus Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AS GEL |
Test Product, Dose, And Route of Administration Test product: AS GEL
Dose: 15 grams of gel daily
Dosage form: Gel
Frequency: Once daily 30 mins. after a meal for 8 weeks.
Route of administration: Oral
|
| Comparator Agent |
Placebo |
Test product: Placebo
Dose: 15 grams of glycerin gel daily
Dosage form: Gel
Frequency: Once daily 30 mins. after a meal for 8 weeks.
Route of administration: Oral
|
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Male and female elderly individuals aged 35-75 (both inclusive).
2. Patients diagnosed with Diabetes Mellitus from the past two years.
3. Patients who give consent for participation in the study.
4. Patients with a BMI more than 23(Kg/m2) |
|
| ExclusionCriteria |
| Details |
1. Treatment with insulin within the last 3 months before the trial.
2. Impaired liver or/and renal function.
3. Patients having an allergy to oral moisturizing creams.
4. Patients who had a salivary gland removal, and patients with Sjogrens
syndrome.
5. Patients having chronic complications of Diabetes, Retinopathy,
Neuropathy and Nephropathy.
6. Patients with the Presence of any oral mucosal lesion.
7. Those with pregnant or lactating, or women of childbearing age who
do not agree to use medication during the trial.
8. Participants who have participated in another clinical trial within 1
month of visit 1 or plan to participate during the clinical trial period.
9. Those who are deemed unable to comply with the test requirements or
otherwise considered as unsuitable according to the investigators
opinion. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) HbA1c
2) Fasting Blood Glucose levels. |
Baseline,10th Week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| CODS Index(Clinical Oral Dryness Score) |
Baseline,10th Week |
| Challacombe scale |
Baseline,10th Week |
| Xerostomia Inventory. |
Baseline,10th Week |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
N/A |
|
Date of First Enrollment (India)
|
06/01/2026 |
| 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
|
This study is a randomized, open-label, two-group, parallel trial designed to evaluate the efficacy and safety of AS JEL in patients with Type II Diabetes Mellitus. A total of 50 participants (25 per group), aged 35–75 years with a BMI >23 kg/m² and diagnosed with diabetes within the past two years, will receive treatment for 10 weeks. The primary endpoints are changes in HbA1c and fasting blood glucose, while secondary endpoints assess oral dryness using the CODS index, Challacombe scale, and Xerostomia Inventory. The study aims to determine whether AS JEL can improve glycemic control and alleviate oral dryness symptoms safely in this patient population. |