| CTRI Number |
CTRI/2015/06/005891 [Registered on: 05/06/2015] Trial Registered Prospectively |
| Last Modified On: |
05/06/2015 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
ASSESSING THE EFFECTIVENESS OF A NEW ANTI-DIABETIC FORMULATION (DIAKURE) |
|
Scientific Title of Study
|
A RANDOMISED, PROSPECTIVE SINGLE BLIND CLINICAL TRIAL OF ANTI DIABETIC POLYHERBAL FORMULATION [DiaKure] |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHAWN TOMY |
| Designation |
RESEARCH SCHOLAR |
| Affiliation |
RVS COLLEGE OF PHARMACEUTICAL SCIENCES |
| Address |
RVS COLLEGE OF PHARMACEUTICAL SCIENCES
242 TRICHY ROAD
SULUR, COIMBATORE
RVS COLLEGE OF PHARMACEUTICAL SCIENCES
242 TRICHY ROAD
SULUR COIMBATORE 641402
Coimbatore
TAMIL NADU
641402
India |
| Phone |
8122472770 |
| Fax |
04222687604 |
| Email |
shawn.kandathil1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
J Sam Johnson |
| Designation |
Asst. Professor |
| Affiliation |
RVS COLLEGE OF PHARMACEUTICAL SCIENCES |
| Address |
RVS COLLEGE OF PHARMACEUTICAL SCIENCES
242 TRICHY ROAD
SULUR COIMBATORE 641402
Coimbatore
TAMIL NADU
641402
India |
| Phone |
9894676716 |
| Fax |
04222687604 |
| Email |
fly2johnny@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
CS Kandasamy |
| Designation |
Professor |
| Affiliation |
RVS COLLEGE OF PHARMACEUTICAL SCIENCES |
| Address |
RVS COLLEGE OF PHARMACEUTICAL SCIENCES
242 TRICHY ROAD
SULUR COIMBATORE 641402
Coimbatore
TAMIL NADU
641402
India |
| Phone |
9842634055 |
| Fax |
04222687604 |
| Email |
kandacognosy@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
RVS COLLEGE OF PHARMACEUTICAL SCIENCES |
| Address |
242 TRICHY ROAD
SULUR, COIMBATORE 641402 |
| Type of Sponsor |
Research institution |
|
|
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 |
| SHAWN TOMY |
AYURVEDA HOSPITAL COIMBATORE |
AYURVEDA HOSPITAL
242TRICHY ROAD
SULUR COIMBATORE 641402
OUR HOSPITAL IS 100 BEDDED WITH 5 MAJOR DEPARTMENTS LIKE GENERAL MEDICINE, PAEDIATRICS, GENERAL SURGEY, ENT, GYNECOLOGY.
Coimbatore
TAMIL NADU |
9952164122
shawn.kandathil1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KG HOSPITAL AND POST GRADUATE MEDICAL INSTITUTE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
DIABETIC, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Metformin/glipizide |
500/5 mg tablets given twice in the morning and at bedtime after food.This regimen will be continued for 180 days. |
| Intervention |
Vetivera Zizanoidis; Hemidesmus Indicus; Strychnos Potatorum; Salacia Reticulata; Acasia Catechu; Holarhena Antidysenterica; Cassia Auriculata; Trigonella Gracun |
12 gm per day as a powder formulation mixed in hot water given twice a day in the morning and at bedtime after food.This regimen will be continued for 180 days. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients diagnosed with type 2 diabetes mellitus.
2. Patient who are keeping up their regular follow-up visits.
3. Patients who are competent enough to consider informed consent. |
|
| ExclusionCriteria |
| Details |
1. Patients who are very frail.
2. Patients in their gestational and lactating period.
3. Patients diagnosed with cardiac and psychiatric disorders.
4. Patients above and below the age group. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Blood sugar levels (both random and fasting) |
Once in 15 days. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Glycosylated Hemoglobin (HbA1c)
BMI |
Once in 60 days. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/07/2015 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Chander et al., A Study of Pharmaceutical Care Impact on Cardiovascular Risk in Diabetic and Hypertensive Patients: IJPSR, 2013;vol 4 (8): 3235-3141 |