| CTRI Number |
CTRI/2017/04/008432 [Registered on: 27/04/2017] Trial Registered Retrospectively |
| Last Modified On: |
24/04/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda
Preventive |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
RANDOMIZED CLINICAL TRIAL TO ASSESS THE EFFECT OF RAJANYADI SYRUP IN THE MANAGEMENT OF PANDU W.S.R. TO IRON DEFICIENCY ANEMIA (IDA) IN CHILDREN |
|
Scientific Title of Study
|
RANDOMIZED CLINICAL TRIAL TO ASSESS THE EFFECT OF RAJANYADI SYRUP IN THE MANAGEMENT OF PANDU W.S.R. TO IRON DEFICIENCY ANEMIA (IDA) IN CHILDREN |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
S Sujan |
| Designation |
PG SCHOLAR |
| Affiliation |
parul institute of ayurveda |
| Address |
parul institute of ayurveda
parul university
limda vadodara
parul institute of ayurved
parul university
limda vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
8015956379 |
| Fax |
|
| Email |
drsujanbams@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil P Changle |
| Designation |
associate proffesor |
| Affiliation |
parul institue of ayurveda |
| Address |
parul institute of ayurveda
parul university
limda vadodara
parul institute of ayurveda
parul university
limda vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9687613916 |
| Fax |
|
| Email |
sunilchangle16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunil P Changle |
| Designation |
associate proffesor |
| Affiliation |
parul institue of ayurveda |
| Address |
parul institute of ayurveda
parul university
limda vadodara
parul institute of ayurveda
parul university
limda vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9687613916 |
| Fax |
|
| Email |
sunilchangle16@gmail.com |
|
|
Source of Monetary or Material Support
|
| Parul Institute of Ayurveda |
|
|
Primary Sponsor
|
| Name |
Parul Institute Of Ayurveda |
| Address |
Parul University
Limda Vadodara-391760 |
| Type of Sponsor |
Private 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 |
| s sujan |
Parul Ayurveda Hospital |
Parul Ayurvedic Hospital
Kawmarabhrtiya Depepartment
Opd no 112
limda vadodara
Vadodara
GUJARAT |
8015956379
drsujanbams@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 |
iron deficency, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
FERROUS FOLICACID TABLETS (FSFA) |
according to standard age dose
Duration: 8weeks
Follow up: 4weeks
|
| Intervention |
rajanyadi syrup |
2-5Years 10ml (in 2 divided doses)
6-9years 20ml (in 2 divided doses)
10-12years 25ml (in 2 divided doses)
Duration: 8weeks
Follow up: 4weeks
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children of 2-12 years of age of either sex
Hemoglobin count below 11.5gm/dl (WHO guideline)
Patients having classical sign and symptoms of Pandu Roga |
|
| ExclusionCriteria |
| Details |
Age below 2years and above 12 years
Hemoglobin count below 6.5gm/dl
Hemoglobinopathies especially thalassemias, sickle cell anemia, aplastic anemia etc.
Sprue syndrome, Worm infestation
Chronic illness like TB, CA etc.
ï‚·Juvenile disorders like DM, RA etc. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
increases the iron level in children
reduces ida |
12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduces the wekness,increse general healt,helps to produce normal mcv,mch,mchc,and pcv valves |
12 weeks |
|
|
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/04/2017 |
| 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="2"
Months="3"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Ayurveda describes the disease Pandu which shows similarities with the iron deficiency anemia the management of IDA is exclusively providing iron supplements. Various factors hamper the digestion and metabolism of iron in the body it was the main cause of Pandu Ayurveda explained the large number of remedies in the form of herbal drugs to treat the Pandu. But the preparation does not contain iron in it correction of metabolism is the important part of nutrition deficiency. Children are in growing age and required increased nutritional demand and also should be treated with the safe and pleasing drug. Rajanyadi Yoga is such combination. By this rajanyadi yoga the iron deficiency anemia will get reduce |