| CTRI Number |
CTRI/2022/05/042422 [Registered on: 09/05/2022] Trial Registered Prospectively |
| Last Modified On: |
05/05/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Clinical Study to Evaluate the Efficacy of Cresvin Beta Capsules in Type II Diabetes Mellitus Patients |
|
Scientific Title of Study
|
A Prospective Randomized Comparative Clinical Study to Evaluate the Efficacy of Cresvin Beta Capsules in Type II Diabetes Mellitus Patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
S N MEENAKSHI SUNDARI |
| Designation |
PROFESSOR |
| Affiliation |
Department of General Medicine SRM Medical College Hospital & Research Centre |
| Address |
SRM Medical College Hospital
and Research Centre
SRM Medical College Hospital and Research Centre
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
|
| Fax |
|
| Email |
dr.meenakshisundari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
T M VIJAYAKUMAR |
| Designation |
Associate Professor |
| Affiliation |
Department of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology, |
| Address |
Department of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur– 603203
Department of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur– 603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
|
| Fax |
|
| Email |
vijaypractice@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
G ASVITHA |
| Designation |
PHARM.D [Intern] |
| Affiliation |
Department of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technolog |
| Address |
Department of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur– 603203
Department of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur– 603203
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
|
| Fax |
|
| Email |
ashvithaa0609@gmail.com |
|
|
Source of Monetary or Material Support
|
| Metabolic ward, Clinical Trial and Research Unit, SRM Medical College Hospital and Research Centre, No:o1, 4th floor,SRM Medical College Hospital and Research Centre, SRM Institute of Science and Technology, Kattankulathur, 603203. Kancheepuram TAMIL NADU
|
|
|
Primary Sponsor
|
| Name |
Apex Laboratories Pvt Ltd |
| Address |
chennai, Tamil Nadu |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| SRM INSTITUTE OF SCIENCE AND TECHNOLOGY |
Kattankulathur, Chengalpattu, Tamil Nadu, India, 603203
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| R C SATISH KUMAR |
Metabolic ward, Clinical Trial and Research Unit, SRM Medical College Hospital and Research Centre |
No:o1, 4th floor,SRM Medical College Hospital and Research Centre, SRM Institute of Science and Technology, Kattankulathur, 603203.
Kancheepuram
TAMIL NADU
Kancheepuram
TAMIL NADU |
9884845887
ayursatish@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM MEDICALCOLLEGE HOSPITAL RESEARCH CENTRE INSTITUTIONAL ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E088||Diabetes mellitus due to underlying condition with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
cresvin beta capsule 500mg |
two times for a day for three months |
| Comparator Agent |
Standard Treatment |
Standard Treatment |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
-Male or female patients within the age range of 18 to 60 years (both years inclusive) diagnosed with T2DM for at least 3 months.
-Willingness to provide written informed consent to participate in the study.
-Patients understanding the nature and purpose of the study and who are willing to comply with study procedures.
-Fasting plasma glucose greater than or equal to 126 mg/dL
-Random plasma glucose greater than 200 mg/dL in a person with symptoms of diabetes.
-Duration of diabetes – Newly diagnosed diabetics or diagnosed within past 5 years
-HbA1C between 7-9.5%
|
|
| ExclusionCriteria |
| Details |
-Type 1 diabetes mellitus
-Patients with severe hyperglycemia (FBS greater than 234 mg per dl or PPBS greater than 360 mg per dl
-HbA1C is more than 9.5 per cent.
-ASAT and ALT levels greater than 2.5 times the upper normal limits
 Severe renal, hepatic, cardiac, gastrointestinal, neurological, hematological or respiratory
 disorders, in view of the investigator.
 Patients with psychiatric disorder.
 History of smoking (more than 10 cigarettes/day) or alcohol intake > 20gm/day.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
-To evaluate the efficacy of Cresvin Beta capsules in Type II Diabetes Mellitus Patients by means of measuring patient FBS, PPBS and HBA1C values.
-To assess adverse drug reactions during the study period.
|
06 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| -To evaluate the adverse drug reaction during the study period.. |
06 months |
|
|
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)
|
11/05/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Publication work will commence after finishing the theoretical section.
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The Patients will be given Cresvin Beta capsules orally
at a dose of 2 tablets twice daily 20
minutes before food for a period of 3 months. The Patients will be evaluated at
the beginning of the study, at 4
weeks, at 8 weeks and at 12 weeks. At
each visit the patients will be
evaluate for efficacy and any adverse effects, vital examination and laboratory investigation. The efficacy parameters are
incidence of Polyuria, Polydipsia, Polyphagia
and peripheral tingling sensation. |