| CTRI Number |
CTRI/2017/03/008152 [Registered on: 20/03/2017] Trial Registered Retrospectively |
| Last Modified On: |
11/03/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to study the effect of lauh bhasma in patient with iron deficiency anaemia |
|
Scientific Title of Study
|
A Clinical Study of Gomutra Bhavita Lauh Bhasma in the management of Pandu (Iron Deficiency Anaemia) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shreeba Jadeja |
| Designation |
PG scholar |
| Affiliation |
Akhandanand Ayurveda Mahavidhyalaya, Ahmedabad. |
| Address |
Department of kayachikitsa
Room no 9
Akhandanand Ayurveda Mahavidhyalaya,Bhadra, Ahmedabad.
Department of kayachikitsa
Room no 9
Akhandanand Ayurveda Mahavidhyalaya,Bhadra, Ahmedabad.
Ahmadabad
GUJARAT
335501
India |
| Phone |
7405600446 |
| Fax |
|
| Email |
shreejadeja.m@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhamini Nirmal |
| Designation |
Lecturer |
| Affiliation |
Akhandanand Ayurveda Mahavidhyalaya, Ahmedabad. |
| Address |
Akhandanand Ayurveda Mahavidhyalaya,Bhadra, Ahmedabad.
Akhandanand Ayurveda Mahavidhyalaya,Bhadra, Ahmedabad.
Ahmadabad
GUJARAT
335501
India |
| Phone |
9427772868 |
| Fax |
|
| Email |
drdhamini.dubal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shreeba Jadeja |
| Designation |
PG scholar |
| Affiliation |
Akhandanand Ayurveda Mahavidhyalaya,Bhadrdabad.Akhandanand Ayurveda Mahavidhyalaya, Ahmedabad. |
| Address |
Department of Kayachikitsa
Room NO. 9
Akhandanand Ayurveda Mahavidhyalaya,Bhadra, Ahmedabad.
Department of Kayachikitsa
Room NO. 9
Akhandanand Ayurveda Mahavidhyalaya,Bhadra, Ahmedabad.
Ahmadabad
GUJARAT
335501
India |
| Phone |
7405600446 |
| Fax |
|
| Email |
shreejadeja.m@gmail.com |
|
|
Source of Monetary or Material Support
|
| Akhandanand Ayurveda Mahavidhyalaya,Bhadra, opposite Tilak Baug
Ahmedabad.
PIN code-335501 |
|
|
Primary Sponsor
|
| Name |
Akhandanand Ayurveda Mahavidhyalaya Ahmedabad |
| Address |
Akhandanand Ayurveda Mahavidhyalaya,Bhadra, Ahmedabad.
|
| Type of Sponsor |
Government medical college |
|
|
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 Shreeba Jadeja |
Akhandanand Ayurveda Mahavidhyalaya, Ahmedabad. |
Department of Kayachikitsa
Room No 9
Akhandanand Ayurveda Mahavidhyalaya,Bhadra, Ahmedabad.
Ahmadabad
GUJARAT |
7405600446
shreejadeja.m@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ANAEMIC PATIENT, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lauh Bhasma with Dugdha |
Lauh Bhasma 125mg in twice a day empty stomach with Dugdha (as a Anupan)
Total Duration 3 month |
| Comparator Agent |
Lauh Bhasma with water |
Lauh Bhasma 125mg in twice a day empty stomach with Water(as a Anupan)
Total Duration 3 month |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Hb.< 12GM%
S. Ferritine <12NG/ML |
|
| ExclusionCriteria |
| Details |
Hb<6GM%
Pregnant and lactating women
Genetic disorder
chronic and acute blood lose
Bleeding disorder
Defective absorption
IDA with systemic disorder |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in symptoms and storage form of iron(s.ferritine) |
3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in symptoms and storage form of iron (s.ferritine) |
2 month |
|
|
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)
|
01/08/2016 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NOT YET PUBLISTI |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This
is a randomized parallel group trial in department of kayachikitsa OPD at Govt.
akhandanand
Ayurveda Mahavidhyalaya Ahmedabad
In
this trial selected patients will be randomly distributed in two groups,
group-A and group-B.
Group-A
:Approx 15 patients of this group, LAUH BHASMA in dose of 125mg twice a day, with dugha(as a anupan), empty stomach for 12 weeks will administrated.
group-B: Approx 15 patients of this group, LAUH BHASMA in dose of 125mg twice a day, with water(as a anupan), empty stomach for 12 weeks will administrate
|