| CTRI Number |
CTRI/2024/12/077860 [Registered on: 09/12/2024] Trial Registered Prospectively |
| Last Modified On: |
04/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Other |
|
Public Title of Study
|
An Open label Randomized study on Efficacy of Blood Glucose Management Herbal Supplement as an adjuvant in Type-II Diabetes Mellitus patients. |
|
Scientific Title of Study
|
A single centric open label randomized study on efficacy of blood glucose management herbal supplement as an adjuvant in Type-II Diabetes Mellitus 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 P Sridhar Reddy |
| Designation |
Principle Investigator |
| Affiliation |
BANU HOSPITAL A UNIT OF PCRI HOSPITALS PVT LTD |
| Address |
BANU HOSPITAL A UNIT OF PCRI HOSPITALS PVT LTD
1-53, 1st line sringar, Before NH-67, NTS gate, Padugupadu, Nellore, Andhra Pradesh, India
Nellore
ANDHRA PRADESH
524137
India |
| Phone |
6300879014 |
| Fax |
|
| Email |
sridhar@pcripl.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gayazuddin Shaik |
| Designation |
Medical Reviewer |
| Affiliation |
BANU HOSPITAL A UNIT OF PCRI HOSPITALS PVT LTD |
| Address |
BANU HOSPITAL A UNIT OF PCRI HOSPITALS PVT LTD
1-53 1st line sringar, Before NH-67, NTS gate, Padugupadu, Nellore, Andhra Pradesh, India
Nellore
ANDHRA PRADESH
524137
India |
| Phone |
8096368108 |
| Fax |
|
| Email |
gayazuddin@pcripl.com |
|
Details of Contact Person
Public Query
|
| Name |
K Vihari |
| Designation |
Clinical Trail Lead |
| Affiliation |
BANU HOSPITAL A UNIT OF PCRI HOSPITALS PVT LTD |
| Address |
BANU HOSPITAL A UNIT OF PCRI HOSPITALS PVT LTD
1-53 1st line sringar, Before NH-67, NTS gate, Padugupadu, Nellore, Andhra Pradesh, India
Nellore
ANDHRA PRADESH
524137
India |
| Phone |
6303282422 |
| Fax |
|
| Email |
vihari@pcripl.com |
|
|
Source of Monetary or Material Support
|
| Diabliss Consumer Products Pvt. Limited, Thiruvanmiyur, Chennai, Tamilnadu, INDIA-600041 |
|
|
Primary Sponsor
|
| Name |
Diabliss Consumer Products Pvt Limited |
| Address |
Diabliss Consumer Products Pvt. Limited, Thiruvanmiyur, Chennai, Tamilnadu, INDIA-600041 |
| Type of Sponsor |
Other [herbal water supplement] |
|
|
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 P Sridhar Reddy |
Banu Hospital – A unit of PCRI Hospitals, Pvt Ltd |
Room No 103, 1st floor, Diabetology department
Banu Hospital A unit of PCRI Hospitals PVT LTD
1-53 1st line sringar, Before NH-67, NTS gate, Padugupadu, Nellore, Andhra Pradesh, India
Nellore
ANDHRA PRADESH |
7989692626
sridhar@pcripl.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PCRI ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy People |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Diabliss Blood Glucose Management Herbal Supplement |
15 ml of Diabliss blood glucose management herbal supplement is mixed with 500 ml of water and Patients should consume this 500 ml supplement in a day in the following manner: 75 ml just before & 75 ml just after breakfast, 75 ml just before & 75 ml just after lunch, 75 ml just before & 75 ml just after dinner and balance 50 ml at bed time. And the type of administration is water intake and Total duration of Intervention is 90 days |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria:
1. Male/ Females subjects between 35-55 years of age
2. Subjects able to communicate effectively.
3. Subjects willing to provide written informed consent
4. In the judgment of the Principal Investigator, able to comply with protocol requirements.
5. Ability to schedule and attend monthly visits for the duration of the study.
6. Subjects with fasting blood glucose levels between 150-250 mg/dL
7. Subjects who are diabetic for one year with standard Diabetic medication
8. Subjects with HbA1C Levels (8% -10%) |
|
| ExclusionCriteria |
| Details |
Exclusion Criteria:
1. Contraindications or Hypersensitivity to study product.
2. History or presence of any medical condition or disease according to the discretion of the Investigator.
3. No contraindications to exercise as outlined by the American Endocrine society (ACS).
4. Patients with Fasting glucose levels more than 250 mg/dL.
5. Patients with diabetes associated with retinopathy
6. Patients with Diabetic Nephropathy and Diabetic Neuropathy
7. Patients with Chronic Cardiovascular diseases.
8. Subjects having abnormal findings on complete blood count
9. Subjects with HIV Positive.
10. Subjects having history of high alcohol intake (greater than 2 standard drinks per day).
11. Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent.
12. Any other condition that, in the opinion of the investigator, would adversely affect the subject’s ability to complete the study or its measures.
13. Subjects participated in any clinical study within thirty (30) days prior to screening.
14. Pregnant Women |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary endpoint:
1.Treatment satisfaction score
2.Treatment preference
3.Quality of life scores
4.Clinical and biochemical markers of Diabetes mellitus |
Day 0 to Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Secondary endpoints:
Safety will be assessed from the number of adverse events occurred and judging their causal relationship to the study herbal supplement. |
Day 0 to Day 90 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
23/12/2024 |
| 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="3"
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 is a randomized, single centric, open label study to evaluate the efficacy of a Diabetes Herbal Supplement in Type 2 diabetes mellitus patients. The aim of the study is to examine the effects of diabetes herbal supplement on symptoms of Diabetes Mellitus, wellbeing and quality of life. The hypothesis is that symptoms of Type-II Diabetes Mellitus, wellbeing and quality of life will be improved in the herbal supplement administered to subjects with reduction in HbA1c, Fasting and Post prandial Glucose levels. The impact of the supplements on lipids will also be documented. The study comprises of 3 Phases: Phase 0- Screening Visit (Day -3 to Day 0) Phase 1- Baseline Visit (Day 0) Phase 2- Follow-Up (Day 1 to Day 30) Phase 3- Follow-Up Visit (Day 90)
|