| CTRI Number |
CTRI/2025/07/090154 [Registered on: 03/07/2025] Trial Registered Prospectively |
| Last Modified On: |
26/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurvedic trial for treatment of panduroga |
|
Scientific Title of Study
|
A Randomised Comparitive Clinical Study To Evaluate The Efficacy Of Vidangadi Loha And Punarnavadi Mandura In Panduroga Wsr To Iron Deficiency Anemia In Children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aiswarya s |
| Designation |
PG SCHOLAR |
| Affiliation |
Rajiv Gandhi University of health sciences, bengalaru |
| Address |
Opd 11 , Department of Kaumarabhrithya,Shri Dharmasthala Manjunatheshwara college of Ayurveda hospital and Research centre kuthpady udupi
Udupi
KARNATAKA
574118
India |
| Phone |
7561849211 |
| Fax |
|
| Email |
aiswaryastephen97@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prathviraj puranik |
| Designation |
B.A.M.S .MD(AYU) Phd, Professor and HOD Kaumarabhrithya |
| Affiliation |
SDM College of Ayurveda kuthpady udupi |
| Address |
Opd no 11, department of Kaumarabhrithya,Shri Dharmasthala Manjunatheshwara college of Ayurveda hospital and Research centre udupi
Shri Dharmasthala Manjunatheshwara college of Ayurveda hospital and Research centre udupi
Udupi
KARNATAKA
574118
India |
| Phone |
9448745477 |
| Fax |
|
| Email |
drprathvirajpuranik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prathviraj puranik |
| Designation |
B.A.M.S .MD(AYU) Phd, Professor and HOD Kaumarabhrithya |
| Affiliation |
SDM College of Ayurveda kuthpady udupi |
| Address |
Opd-11, Department of Kaumarabhrithya,Shri Dharmasthala Manjunatheshwara college of Ayurveda hospital and Research centre udupi
Udupi
KARNATAKA
574118
India |
| Phone |
7561849211 |
| Fax |
|
| Email |
drprathvirajpuranik@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kaumarabhrithya opd number11 SDM College of Ayurveda hospital kuthpady udupi 574118 Karnataka india |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 Aiswarya s |
Shri Dharmasthala Manjunatheshwara Ayurveda hospital kuthpady udupi 574118 |
OPd number 11, Department of Kaumarabhrithya ,Shri Dharmasthala Manjunatheshwara
college of Ayurveda hospital kuthpady udupi 574118 Karnataka india
Ayurveda hospital and research centre kuthpady udupi
Udupi
KARNATAKA |
7561849211
aiswaryastephen97@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Clearance Committee Human |
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 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Punarnavadi mandura , Reference: Charaka samhitha , Route: Oral, Dosage Form: Lauha-Mandura, Dose: 1(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Takra), Additional Information: - | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Vidangadi loha, Reference: Bhaishajya ratnavali , Route: Oral, Dosage Form: Lauha-Mandura, Dose: 2(g), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Sukhoshna jala), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
The children of age group 4 years fullfilling the diagnostic criteria
Children who have taken prior written assent from his or her parent |
|
| ExclusionCriteria |
| Details |
Children having history of systemic illness which interfers the treatment
Children with acute symptoms of IDA requiring blood transfusion
Children with other congenital disorders related with haemopoetic system like thalassemia sickle cell anemia leukemia
Children with neurobehavioral disorders like ADHD autism developmental disorders like cerebral palsy protein energy malnutrition metabolic disorders systemic infections |
|
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Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Vidangadi loha may show better results in panduroga comparison to punarnavadi mandura |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Vidangadi loha may have better results on signs and symptoms of panduroga |
30 days |
|
|
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 3 |
|
Date of First Enrollment (India)
|
10/07/2025 |
| 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="0"
Days="6" |
|
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
|
There are reasearch articles showing vidangadi loha in adult group but not in paediatric age group punarnavadi mandura is a drug which is used both in paediatric and adult group loha and mandura preparations are widely used in ayurveda to treat panduroga by considering the fact that reduced iron storage is replaced by iron itself and also ingredients of vidangadi loha have the ability to break the pathogenesis of panduroga so present study is planned to evaluate the efficacy of vidangadi loha and punarnavadi mandura in management of panduroga wsr to iron deficiency anemia in children if 4 yrs |