| CTRI Number |
CTRI/2016/12/007598 [Registered on: 19/12/2016] Trial Registered Retrospectively |
| Last Modified On: |
20/12/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Haematinic action of Beet root and Prickly pear |
|
Scientific Title of Study
|
Clinical evaluation of beet root and prickly pear in the management of Anemia: A Randomized clinical 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 Sanjay P Chauhan |
| Designation |
Associate Professor |
| Affiliation |
Faculty of Pharmacy, Dharmsinh Desai University |
| Address |
College road, Nadiad
J.S. Ayurved Mahavidyalaya,
College road,
Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
09427614966 |
| Fax |
|
| Email |
sanjaychauhan.ph@ddu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sanjay P Chauhan |
| Designation |
Associate Professor |
| Affiliation |
Faculty of Pharmacy, Dharmsinh Desai University |
| Address |
College road, Nadiad
J.S. Ayurved Mahavidyalaya,
College road,
Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
09427614966 |
| Fax |
|
| Email |
sanjaychauhan.ph@ddu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sanjay P Chauhan |
| Designation |
Associate Professor |
| Affiliation |
Faculty of Pharmacy, Dharmsinh Desai University |
| Address |
College road, Nadiad
J.S. Ayurved Mahavidyalaya,
College road,
Nadiad
Kheda
GUJARAT
387001
India |
| Phone |
09427614966 |
| Fax |
|
| Email |
sanjaychauhan.ph@ddu.ac.in |
|
|
Source of Monetary or Material Support
|
| Gujarat Council on Science and Technology (Gujcost)
Block B, 7th Floor, M. S. Building,
Near Pathikashram, Sector 11,
Gandhinagar - 382011, Gujarat |
|
|
Primary Sponsor
|
| Name |
Faculty of Pharmacy Dharmsinh Desai University |
| Address |
College road Nadiad - 387001, Gujarat |
| Type of Sponsor |
Government funding agency |
|
|
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 Sanjay P Chauhan |
P D Patel Ayurvedic Hospital, Panchkarma Department |
J. S. Ayurvedic Mahavidyalaya
College road, Nadiad - 387001
Kheda
GUJARAT |
9427614966
sanjaychauhan.ph@ddu.ac.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Human Studies of JS Ayurved Mahavidyalaya |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Anemic and Hb in between 8 to 10, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Beet root Capsule (500 mg) |
Capsule three times a day for 60 days, Orally |
| Intervention |
Prickly pear Capsule (500 mg) |
Capsule three times a day for 60 days, Orally |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Haemoglobin level between 8 to 10 gm |
|
| ExclusionCriteria |
| Details |
(1) Pregnancy and lactation
(2) Any other chronic clinical conditions like kidney and liver disfuntion
(3) Any continuing blood loss e.g. Haematemesis, Melaena, bleeding piles etc.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| this project provides important initiative and facet for further research to find out efficacy profile of beet root and prickly pear in the management of anemia. |
Estimate CBC on zore, 30 and 60th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Safety profile of beet root and prickly pear |
estimate liver and kidney function tests on zero, 30 and 60th day |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
05/09/2013 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Yet not done |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Present research will
focus on clinical evaluation of traditional nutritional supplements in the
management of anemia. At present only ferrous salts are available for the
treatment of anemia, while beet root and prickly pear traditionally used in the
anemia, but there is no sufficient scientific evidence for the same. Outcome of
this project may provide important initiative and facet for further research to
find out efficacy and safety profile of beet root and prickly pear in the
management of anemia. |