| CTRI Number |
CTRI/2024/10/074975 [Registered on: 09/10/2024] Trial Registered Prospectively |
| Last Modified On: |
21/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Trial To Study Evaluation Of Rajanyadi Churna In Management Of Pandu w r t Iron Deficiency Anemia In Adolescents |
|
Scientific Title of Study
|
Evaluation Of Rajanyadi Churna In Management Of Pandu w r t Iron Deficiency Anemia In Adolescents – A Randomised Controlled Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Savita Sunadholi |
| Designation |
PG Scholar |
| Affiliation |
KAHER Shri B M Kankanawadi Ayurveda Mahavidyalaya Belagavi Karnataka |
| Address |
Department of Kaumarabhritya KAHER Shri B M Kankanawadi Ayurveda Mahavidyalaya Belagavi Karnataka
Belgaum
KARNATAKA
590003
India |
| Phone |
8073620576 |
| Fax |
|
| Email |
savitasunadholi17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aziz Arbar |
| Designation |
HOD and Professor |
| Affiliation |
KAHER Shri B M Kankanawadi Ayurveda Mahavidyalaya, Belagavi Karnataka |
| Address |
Department of Kaumarabhritya KAHER Shri B M Kankanawadi Ayurveda Mahavidyalaya Belagavi Karnataka
Belgaum
KARNATAKA
590003
India |
| Phone |
9844532113 |
| Fax |
|
| Email |
azizarbar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aziz Arbar |
| Designation |
HOD and Professor |
| Affiliation |
KAHER Shri B M Kankanwadi Ayurveda Mahavidyalaya Belagavi Karnataka |
| Address |
Department of Kaumarabhritya KAHER Shri B M Kankanwadi Ayurveda Mahavidyalaya Belagavi Karnataka
Belgaum
KARNATAKA
590003
India |
| Phone |
9844532113 |
| Fax |
|
| Email |
azizarbar@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHER Shri B M Kankanawadi Ayurveda Mahavidyalaya Post Graduate Studies And Research Centre Shahapur Belagavi Karnataka India 590003 |
|
|
Primary Sponsor
|
| Name |
Dr Savita Sunadholi |
| Address |
KAHER Shri B M Kankanawadi Ayurveda Mahavidyalaya Post Graduate Studies And Research Centre Shahapur Belagavi Karnataka India 590003 |
| Type of Sponsor |
Other [Self] |
|
|
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 Savita Sunadholi |
KAHER Shri B M Kankanawadi Ayurveda Mahavidyalaya and KLE Ayurveda Hospital Belagavi Karnataka |
OPD number 10 Department of Kaumarabhritya Belagavi Karnataka
Belgaum
KARNATAKA |
8073620576
savitasunadholi17@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Research On Human Subjects |
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: RAJANYADI CHURNA, Reference: ASHTANGA HRUDAYA UTTARASTHANA CHAPTER NO.2 BALAMAYAPRATISHEDHADHYAYA SHLOKA NO.38-40, Route: Oral, Dosage Form: Churna/ Powder, Dose: 2(g), Frequency: od, Bhaishajya Kal: Madhyabhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -MADHU AND GHRUTA), Additional Information: - | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: PUNARNAVADI MANDUR, Reference: CHARAKA SAMHITA CHIKITSA STHANA CHAPTER NO.16 PANDUROGA CHIKITSITAM SHLOKA NO.93-95, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -WATER), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Children of either sex from age 10 to 16 years
Children with mild and moderate severity of anemia according to WHO Hb
threshold
Children fulfilling the diagnostic criteria |
|
| ExclusionCriteria |
| Details |
Children having any other known type of anemia except IDA
Children having IDA with any associated severe complication like CCF,Splenomegaly etc.
Children with severe developmental disabilities such as autism, cerebral palsy etc.
Children with any known pathology associated with kidney, liver etc
Children with any known bleeding disorders, genetic disorders, metabolic
disorders etc
Children who have received any form of supplements for IDA in last 1 month |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| measured by changes in HB% |
0 day
15 day
30 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| measured by changes in Peripheral Smear and lakshana’s of Pandu through gradings |
0 day
15 day
30 day |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/01/2025 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Iron deficiency anemia (IDA) is the most frequent hematological and nutritional disorder of childhood and adolescence which is the commonest form of anemia.1 Approximately 25% of people worldwide have anemia. Iron deficiency, the most common cause, is responsible for 50% of all anemia.2 Data from the NFHS5 shows that 57% Indian adolescent girls and 31% boys are anemic. The prevalence of anemia has remained unchanged over the last 3 decades.3 Iron deficiency anemia can cause diminished growth and learning and have serious consequences such as Congestive cardiac failure, splenomegaly in children which indirectly affecting the quality of life in children.4 The widely used medications for treating IDA are oral iron preparations (ferrous fumarate etc.) which have adverse effects such as nausea, epigastric distress, decreased appetite, flatulence, constipation or diarrhea.5 The adverse effect of Intravenous iron therapy such as Extravasation of iron solutions into the subcutaneous tissue which causes brownish stains that can be permanent and aesthetically unpleasant for the patient.6 Therefore there is a need to overcome the consequences of iron therapies and to help in improving the growth and cognitive deficits caused by IDA. In Ayurveda there are various formulations known for their efficacy in treating Pandu roga with their karmas like Deepana, Pachana, Srotoshodhana, Rasa Dhatu prasadaka. One such preparation is Rajanyadi churna, which is mentioned in Pandu roga. Therefore, this study is taken to address the management of Pandu roga in children with Rajanyadi churna . |