| CTRI Number |
CTRI/2019/11/022083 [Registered on: 20/11/2019] Trial Registered Prospectively |
| Last Modified On: |
28/07/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical trial on type 2 diabetes patients |
|
Scientific Title of Study
|
An Open labeled, Non Randomized, Clinical study to Evaluate the Glucose Lowering effect of KAL-10 Meal in patients with type 2 diabetes Mellitus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| KAL-10/02/2019 Version 2.0 Dated 2nd August 2019 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Jayashree M |
| Designation |
Senior Scientific officer |
| Affiliation |
Kerala Ayurveda Limited |
| Address |
#1134, 1st Floor, 100 Feet Road,HAL 2nd Stage, Indiranagar,
Bengaluru, India
Bangalore
KARNATAKA
560008
India |
| Phone |
9880677814 |
| Fax |
|
| Email |
jayashree@keralaayurveda.us |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Jayashree M |
| Designation |
Senior Scientific officer |
| Affiliation |
Kerala Ayurveda Limited |
| Address |
#1134, 1st Floor, 100 Feet Road,HAL 2nd Stage, Indiranagar,
Bengaluru, India
Bangalore
KARNATAKA
560008
India |
| Phone |
9880677814 |
| Fax |
|
| Email |
jayashree@keralaayurveda.us |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Jayashree M |
| Designation |
Senior Scientific officer |
| Affiliation |
Kerala Ayurveda Limited |
| Address |
#1134, 1st Floor, 100 Feet Road,Medical Department
Room HAL 2nd Stage, Indiranagar,
Bengaluru India.
Bangalore
KARNATAKA
560008
India |
| Phone |
9880677814 |
| Fax |
|
| Email |
jayashree@keralaayurveda.us |
|
|
Source of Monetary or Material Support
|
| Kerala Ayurveda Limited
#1134, 1st Floor, 100 Feet Road,
HAL 2nd Stage, Indiranagar,
Bengaluru – 560008, India
|
|
|
Primary Sponsor
|
| Name |
Kerala Ayurveda Limited |
| Address |
#1134, 1st Floor, 100 Feet Road,
HAL 2nd Stage, Indiranagar,
Bengaluru – 560008, India
|
| Type of Sponsor |
Other [Ayurveda based company ] |
|
|
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 |
| DrAmarnath Reddy |
Shettys Hospital |
Ground floor Room number 2 Plot No, 11 & 12, 12th F Main Rd, Kaveri Nagar, Bommanahalli, Bengaluru, Karnataka 560068
Bangalore
KARNATAKA |
8105815867
dramarclinicblr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shettys hospital 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 |
KAL-10 meal (Food product) |
03 scoops KAL-10 mealwith morning meal,After noon and evening meal daily for a period of 12 weeks |
| Comparator Agent |
Not applicable (Single arm study) |
Not applicable ((Single arm study) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients in the age group of 18 to 60 years, both inclusive.
2. Patients suffering from Type II Diabetes Mellitus for more than one
year, and stabilized on mono / poly oral hypoglycemic drug underanti-diabetic therapy.
3. Patients having HbA1c value below 8% at screening.
4. Patients of female gender or non-pregnant, non-lactating females.
A urine pregnancy test is required for all female subjects of
childbearing potential unless subject has had a hysterectomy, tubal
ligation, or is > 2 years postmenopausal.
5. Patients who willing to follow the procedures as per the study
protocol and voluntarily sign an informed consent form. |
|
| ExclusionCriteria |
| Details |
1. Type-I & Type-II Diabetic patients who are on Insulin.
2. Known cases of severe/chronic hepatic or renal disease.
3. Known patient of any active malignancy.
4. Patients giving history of significant cardiovascular event 5.
Patients having history of known major complications of Diabetes like
Ketoacidosis, Nephropathy, Neuropathy, Retinopathy, and Diabetic
wounds.
6. Patients having history of known chronic, contagious infectious
disease, such as active tuberculosis, Hepatitis B or C, or HIV.
7. Known patients of having active metabolic or gastrointestinal
diseases that may interfere with nutrient absorption, metabolism, or
excretion, excluding diabetes.
8. Patients using any other investigational drug within 1 month prior
to recruitment
9. Patients currently participating in any other clinical study
10. Any other condition due to which patients are deemed to be
unsuitable by the investigator for reason(s) not specifically stated in
the exclusion criteria |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Evaluate changes in level of HbA1c after 12
weeks intake of KAL-10 meal |
Base line and Week 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Evaluate the effect of KAL-10 meal by
observing changes on FBG and PPG and lipid
profile after 12 weeks intake of KAL-10 meal
2. Evaluate Changes in glucose level by
continuous glucose monitoring for 2 weeks
following intake of KAL-10 meal in a subset from the baseline.
3. Evaluate changes in weight, body mass index
after 12 week intake of KAL-10 meal
|
Baseline to Week 12 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
28/11/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Kerala Ayurveda Limited innovative product KAL-10 meal is a holistic Ayurveda principle based food to help in type 2 diabetes patients lower blood glucose to healthy levels.
|