| CTRI Number |
CTRI/2017/12/010856 [Registered on: 13/12/2017] Trial Registered Retrospectively |
| Last Modified On: |
08/04/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of ayurvedic drug KAL-10 on diabetes and related conditions |
|
Scientific Title of Study
|
Effect of ayurvedic drug KAL-10 on lowering hyperglycemic in subjects with diabetes: A Randomized Placebo Controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S K Singh |
| Designation |
Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Endocrinology and Metabolism
Faculty of Medicine
Institute of Medical Sciences
Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
|
| Fax |
|
| Email |
sksendocrine@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jayashree M |
| Designation |
Manager - Technical Marketing and Research |
| Affiliation |
|
| Address |
No. 1134, 1st floor, 100 feet road, HAL 2nd stage, Indiranagar, Bengaluru
Bangalore
KARNATAKA
560008
India |
| Phone |
9880677814 |
| Fax |
08041808043 |
| Email |
jayashree@katraphyto.com |
|
Details of Contact Person
Public Query
|
| Name |
Jayashree M |
| Designation |
Manager - Technical Marketing and Research |
| Affiliation |
|
| Address |
No. 1134, 1st floor, 100 feet road, HAL 2nd stage, Indiranagar, Bengaluru
Bangalore
KARNATAKA
560008
India |
| Phone |
|
| Fax |
08041808043 |
| Email |
jayashree@katraphyto.com |
|
|
Source of Monetary or Material Support
|
| Kerala Ayurveda Limited,
no. 1134, 1st Floor, 100 Feet Road, HAL 2nd Stage, Indiranagar, Bangalore - 560008 |
|
|
Primary Sponsor
|
| Name |
Kerala Ayurveda Limited |
| Address |
1134, 1st floor, 100 ft road, HAL 2nd stage, Indiranagar, Bangalore |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
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 S K Singh |
Banaras Hindu University |
Department of Endocrinology and Metabolism, Institute of Medical Sciences, BHU, Varanasi
Varanasi
UTTAR PRADESH |
9369192077
awanindra.bhu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee- Banaras Hindu University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Type 2 Diabetes Mellitus, (1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHAH, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
KAL 10 Plus |
Ayurvedic drug, 650 mg capsule twice daily for 12 weeks, oral route |
| Intervention |
KAL-10 |
Ayurvedic drug, KAL-10 (600 mg) capsule twice daily for 12 weeks, oral route |
| Comparator Agent |
Placebo |
Placebo, 600 mg capsule twice daily for 12 weeks, oral route |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Informed consent obtained before any trial-related activities
Male or female patients between 18 to 70 years of age
Newly diagnosed with hyperglycemia
FBS≥110 mg/dL but ≤200 mg/dL, measured on day-1
PPBS >120 mg/dL and ≤ 200 mg/dL
HbA1c 6% ≥ & ≤ 10%
C peptide ≥ 1.0 ng/ml
Ability to comply with study requirements
|
|
| ExclusionCriteria |
| Details |
Females who are pregnant and/or lactating and/or sexually active but not using an acceptable method of contraception
History of allergy or contraindications to the ingredients present in the drug
History of uncontrolled or poorly controlled serum cholesterol
Renal impairment/insufficiency (i.e., nephritis, polycystic kidney disease, acute or chronic renal failure, end stage renal disease, >1.5 times the upper limit of normal (ULN) of serum Creatinine, etc.)
AST, ALT >3 times the ULN
Thyroid dysfunction
Gastrointestinal disorders (ulcerative colitis, etc.)
Hepatic impairment/ acute liver disease or persistent elevations in liver function tests (3 times the upper limit of normal (ULN) of LFT Uncontrolled hypertension, as defined by SBP >160 mmHg or DBP >100 mmHg while on anti-hypertensive medication
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Statistically significant reduction in fasting blood glucose
Reduction in total triglyceride
Reduction in postprandial blood glucose level from the baseline
Decrease in HbA1c levels
Improvement in Insulin sensitivity
C-Peptide |
Base line Visit (visit-1) (Day 0)
2nd interim visits (visit 2) (Day 30)
3rd interim visits (visit -3) (Day 60)
Last visit (visit-4) (Day 90)
|
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
Reduction in Cholesterol and LDL levels
Improvement in HDL levels
Clinical chemistry |
Base line Visit (visit -1) (Day 0)
Last visit (visit-4) (Day 90) |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
17/05/2013 |
| Date of Study Completion (India) |
20/12/2016 |
| 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
|
kindly note that we have not yet published this clinical study |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Metabolic syndrome is defined as a group of factors that when present in an individual can lead to coronary heart disease, stroke and or Type II Diabetes. The two main risk factors include increased weight and insulin resistance. Other contributing factors including genetic history, age, hormone changes as well as lack of exercise. Control of body weight and reduction of sugars thus plays an important role for in the treatment of metabolic disorder and the prevention of Type II diabetes and heart disease. KAL-10 and KAL-10 Plus are Ayurvedic formulations which are designed to treat metabolic syndrome such as Type II Diabetes. KAL-10 is defined as purely herbal preparation. KAL-10 Plus is defined as KAL-10 containing microgram quantities of mineral and amino acids. These formulations contain Ayurvedic herbs prepared by a proprietary process to enhanced efficacy.
This study is a Randomized, Placebo Controlled,
parallel group, single center monotherapy trial comparing the efficacy of
KAL-10 at 600 mg and KAL-10 Plus 650 mg twice daily for 12 weeks in patients
with type-II diabetes that will be conducted in Banaras Hindu University,
India. The primary outcome measures will be to monitor Fasting Blood Sugar level,
postprandial blood glucose level and HbA1c level reduction, in addition to improvement in insulin sensitivity, reduction in c-peptide levels and reduction in total triglycerides at 12 weeks. The secondary outcome will be to observe the improvement in lipid
profile. Comparator agent will be a
placebo.
|