| CTRI Number |
CTRI/2024/04/065871 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
10/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Suvarnamakshik Bhasma and Amalaki Rasayan in school children suffering from Anemia due to Iron deficiency |
|
Scientific Title of Study
|
Randomized controlled trial to assess the efficacy of Suvarnamakshik Bhasma & Amalaki Rasayana in management of Iron deficiency Anemia in school age 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 |
Yogita Shrivas |
| Designation |
Professor |
| Affiliation |
Datta Meghe Ayurvedic Medical College Hospital & Research centre, Nagpur |
| Address |
HOD room, Dpt of Kaumarbhritya ,fourth floor, College Building, DMAMACHRC,YCCE campus Wanadongri,
Hingna , Nagpur
Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
07083308259 |
| Fax |
|
| Email |
yogitashrivas@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Yogita Shrivas |
| Designation |
Professor |
| Affiliation |
Datta Meghe Ayurvedic Medical College Hospital & Research centre, Nagpur |
| Address |
HOD room, Dpt of Kaumarbhritya ,fourth floor, College Building, DMAMACHRC,YCCE campus Wanadongri,
Hingna , Nagpur
Nagpur
Nagpur
MAHARASHTRA
440019
India |
| Phone |
07083308259 |
| Fax |
|
| Email |
yogitashrivas@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Yogita Shrivas |
| Designation |
Professor |
| Affiliation |
Datta Meghe Ayurvedic Medical College Hospital & Research centre, Nagpur |
| Address |
HOD room, Dpt of Kaumarbhritya ,fourth floor, College Building, DMAMACHRC,YCCE campus Wanadongri,
Hingna , Nagpur
Nagpur
H
Nagpur
MAHARASHTRA
440019
India |
| Phone |
07083308259 |
| Fax |
|
| Email |
yogitashrivas@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Maharshtra University of Health Sciences |
|
|
Primary Sponsor
|
| Name |
Maharshtra University of Health Sciences |
| Address |
Gangapur Road, Nashik ,Maharashtra, India |
| 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 Yogita Shrivas |
Datta Meghe Ayurvedic Medical College Hospital & Research center |
Datta Meghe Ayurvedic Medical College Hospital & Research center, wanadongri, Hingna, Nagpur
Balrog OPD
YCCE college campus
Wanadongri
Hingna
Nagpur
Nagpur
MAHARASHTRA |
07083308259
yogitashrivas@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NYSS Ayurveda Physiotherapy Nursing (APN)Colleges Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D509||Iron deficiency anemia, unspecified. Ayurveda Condition: PANDUROGAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Suvarnamakshik Bhasma, Reference: RasaTarangini , Route: Oral, Dosage Form: Bhasma, Dose: 50(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: honey ), Additional Information: -(2) Medicine Name: Amalaki Rasayan , Reference: RasaTantra Sar evam Siddha Prayoga Sangraha, Route: Oral, Dosage Form: Churna/ Powder, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: honey ), Additional Information: | | 2 | Comparator Arm (Non Ayurveda) | | - | ferrous fumarate in syrup form 100mg/5 ml equivalent to 32.8 mg elemental iron | 3 mg/kg per day orally in two divided doses for two months |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children of either sex between 6 to 12 years of age Hb less than 12 gm%
Microcytic hypochromic anemia on peripheral blood smears (PBSs)
Children whose parents give consent to undertake the trial |
|
| ExclusionCriteria |
| Details |
Blood Hb less than 6 gm per dL
Known case of Sickle cell anaemia thalassemia or other forms of haemolytic anaemia
Children requiring blood transfusion
history of any systemic illness
children undergoing any long term treatments for systemic disease
history of fresh bleed in or out of any part of body
Patient having occult blood positive on stool examination
Any other type of anaemia except IDA
IDA with any associated severe complication |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
effectiveness of Suvarnamakshik Bhasma and Amalaki Rasayana in increasing the hemoglobin percentage in iron deficiency anaemia in school age children.
|
on day 0 and day 60th |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| increase in haemoglobin percentage in school age children with iron deficiency anaemia |
on day 0, day 15th, day 30th , day 45th & day 60th |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
25/04/2024 |
| 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="6"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The current study is a randomized controlled trial to study the efficacy of Suvarnamakshik Bhasma and Amalaki Rasayana in management of Iron deficiency anaemia in school age children. India being a developing country factors like socio economic state, awareness about nutrition and dedication to childhood care, environmental factors affect the quality of child diet.Wrong food practices also add to the problem. Thus, gradually anaemia sets in very easily in the paediatric age group.School age children are transiting through a phase of rapid growth and development .During this time they require high energy for maintaining normal body functions as well as for growth and development. Hence the need to find an economic and palatable in children , therapeutic Ayurveda solution is need of the hour . |