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CTRI Number  CTRI/2017/07/009164 [Registered on: 28/07/2017] Trial Registered Retrospectively
Last Modified On: 28/05/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Probiotic 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study to evaluate, safety and efficacy of probiotic UB 0316 as an adjuvant in adults suffering from Type II diabetes in comparison with placebo. 
Scientific Title of Study   A double blind, randomized, placebo controlled study to determine the safety and efficacy of UB 0316 as an adjuvant for 12 weeks in type 2 diabetes mellitus. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
IHS/UBL/03/16 (Version 1.0 - 20/06/16)  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anirudh Tripathi  
Designation  Principal Investigator 
Affiliation  Life Veda Treatment and Research Centre 
Address  Life Veda Treatment and Research Centre 7/6, Century Quarters, Next to Doordarshan towers, P.B.road Worli, Mumbai-400030

Mumbai
MAHARASHTRA
Mumbai-400030
India 
Phone  91-9820180084  
Fax    
Email  dranirudh_t@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jayanthi Neelamraju 
Designation  Manager- Business Development  
Affiliation  Unique Biotech Ltd. 
Address  Block:G-43, Madhura Nagar, Yousufguda, Hyderabad - 500 038, India
Plot no 2. Phase II, Alexandria Knowledge Park, Kolthur Village, Shameerpet Mandal, Ranga Reddy Dist. Hyderabad - 500078
Rangareddi
ANDHRA PRADESH
Hyderabad-500078
India 
Phone  91-4023751346  
Fax    
Email  jayanthi@uniquebiotech.com  
 
Details of Contact Person
Public Query  
Name  Dr Jayanthi Neelamraju 
Designation  Manager- Business Development  
Affiliation  Unique Biotech Ltd. 
Address  Block:G-43, Madhura Nagar, Yousufguda, Hyderabad - 500 038, India
Plot no 2. Phase II, Alexandria Knowledge Park, Kolthur Village, Shameerpet Mandal, Ranga Reddy Dist. Hyderabad - 500078
Rangareddi
ANDHRA PRADESH
Hyderabad-500078
India 
Phone  91-4023751346  
Fax    
Email  jayanthi@uniquebiotech.com  
 
Source of Monetary or Material Support  
Unique Biotech Ltd Plot no 2. Phase II, Alexandria Knowledge Park, Kolthur Village, Shameerpet Mandal, Ranga Reddy Dist. Hyderabad - 500078 
 
Primary Sponsor  
Name  Unique Biotech Ltd 
Address  Unique Biotech Ltd., G-43, Madhura Nagar, Yousufguda, Hyderabad. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anirudh Tripathi  Life Veda Treatment and Research Centre  7/6, Century Quarters, Next to Doordarshan towers, P.B.road Worli, Mumbai-400030
Mumbai
MAHARASHTRA 		 91-9820180084

dranirudh_t@yahoo.com 
Dr Satyavrat Nanal  Nanal Ayurvedic Clinic.  Room no - 102, Anand bhuvan, Gorewadi, Opposite MTNL Colony, Near Matunga Road Railway station,Mahim west, Mumbai – 400016.
Mumbai
MAHARASHTRA 		 91-9892229523

srnanal@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Intersystem Biomedica Ethics Committee  Approved 
Intersystem Biomedica Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Diabetes mellitus type 2,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  2 capsules/per orum/per day for 12 Weeks  
Intervention  UB-0316  2 UB0316 capsules/per orum/per day for 12 Weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Male or female outpatient between the ages of 18- 65 years.
2.Subject states that he/she has type 2 diabetes (as evidenced by use of stable metformin monotherapy medication for at least 8 weeks prior to screening).
3.Subject has an HbA1c level ≥ 7 % & ≤ 9%
4.Subject’s BMI is > 23 kg/m2 and < 32 kg/m2
5.If on anti-hyperglycemic, anti-hypertensive, lipid-lowering, or thyroid medications or hormone therapy, has been on constant dosage for at least six months prior to screening visit.
6.Female, not currently pregnant or breast feeding and are using mechanical contraceptive devices such as Intra-uterine devices (IUD). (Barrier method of birth control; abstinence) prior to entry into study, during the period of study participation.
7.Ability to understand and the willingness to sign and date a written Informed Consent document at the screening visit before any protocol specific procedures are performed

 
 
ExclusionCriteria 
Details  1.Subject states that he/she has type 1 diabetes.
2.Subject states that he/she has history of diabetic ketoacidosis.
3.Subject uses anti-hyperglycemic medication other than metformin for glucose control.
4.Subject has fasting blood triglycerides > 400 mg/dL and/or LDL cholesterol > 190 mg/dL at screening.
5.Subject has an HbA1c level > 9.0% at screening.
6.Known hypersensitivity to any of the study drugs or constituents.
7.Subjects suffering from severe systemic disease.
8.Subjects receiving any Ayurvedic, Homeopathic or Herbal drug continuously for one month; in last 30 days during screening visit.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. The primary outcome is change in hemoglobin A1c from baseline to week 12  1. The primary outcome is change in hemoglobin A1c from baseline to week 12 
 
Secondary Outcome
Modification(s)  
Outcome  TimePoints 
1. Change in blood glucose levels from baseline to week 12
2. Change in fasting blood lipids (total cholesterol, LDL cholesterol, HDL cholesterol, VLDL cholesterol, triglycerides) from baseline to week 12
3. Change in body weight from baseline to week 12
4. Change in Quality of Life (QOL) from baseline to week 12
5. Change in insulin levels from baseline to week 12
7. Change in HOMA-IR from baseline to week 12.
 		 1. Change in blood glucose levels from baseline to week 12
2. Change in fasting blood lipids (total cholesterol, LDL cholesterol, HDL cholesterol, VLDL cholesterol, triglycerides) from baseline to week 12
3. Change in body weight from baseline to week 12
4. Change in Quality of Life (QOL) from baseline to week 12
5. Change in insulin levels from baseline to week 12
7. Change in HOMA-IR from baseline to week 12.

 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
Final Enrollment numbers achieved (Total)= "79"
Final Enrollment numbers achieved (India)="79" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   12/01/2017 
Date of Study Completion (India) 25/01/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Given the potential role of the intestinal microbiota in metabolic disorders, it is reasonable to hypothesize that restoration or supplementation of certain microbial populations may have a beneficial effect. Similarly, our probiotic formulation may influence the energy metabolism, lipolysis, anti-inflammatory effect and regulate the gut microbiota to support the Diabetes treatment. This may probably establish overall relation of gut-health and diabetes. Therefore; the aim of this study is to investigate the UB0316 capsule supplementation for diabetes. The primary objective of the study to determine the safety and efficacy of UB0316 as an adjuvant for 12 weeks in type 2 diabetes mellitus. 


 
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