| CTRI Number |
CTRI/2025/10/096288 [Registered on: 22/10/2025] Trial Registered Prospectively |
| Last Modified On: |
15/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Clinical Study to assess the effect of Rajanyadi Churna in the management of Iron Deficiency Anemia (Pandu Rago) in Children. |
|
Scientific Title of Study
|
A clinical study of Rajanyadi Churna in the management of Pandu Roga with special reference to Iron Deficiency Anemia 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 |
Gunjal Priya |
| Designation |
PG Scholar(Ayu.) Department of Kaumarbhritya |
| Affiliation |
Government Ayurvedic College and Hospital, Patna |
| Address |
Department of Kaumarbhritya, Government Ayurvedic College and Hospital, Landmark-Buddha Murti, Kadamkuan, Patna-800003, Bihar
Patna
BIHAR
800003
India |
| Phone |
8340135811 |
| Fax |
|
| Email |
gunjal.priya26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arvind Chaurasia |
| Designation |
Professor and HOD, Department of Kaumarbhritya |
| Affiliation |
Government Ayurvedic College and Hospital, Patna |
| Address |
Department of Kaumarbhritya, Government Ayurvedic College and Hospital, Landmark-Buddha Murti, Kadamkuan, Patna-800003, Bihar
Patna
BIHAR
800003
India |
| Phone |
9835255180 |
| Fax |
|
| Email |
arvindschaurasia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gunjal Priya |
| Designation |
PG Scholar(Ayu.) Department of Kaumarbhritya |
| Affiliation |
Government Ayurvedic College and Hospital, Patna |
| Address |
Department of Kaumarbhritya, Government Ayurvedic College and Hospital, Landmark-Buddha Murti, Kadamkuan, Patna-800003, Bihar
Patna
BIHAR
800003
India |
| Phone |
8340135811 |
| Fax |
|
| Email |
gunjal.priya26@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Ayurvedic College and Hospital, Landmark-Buddha Murti, Kadamkuan, Patna-800003, Bihar |
|
|
Primary Sponsor
|
| Name |
Gunjal Priya |
| Address |
Department of Kaumarbhritya, Government Ayurvedic College and Hospital, Landmark-Buddha Murti, Kadamkuan, Patna-800003, Bihar |
| 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 Gunjal Priya |
Government Ayurvedic College and Hospital, Patna |
Department of Kaumarbhritya, Government Ayurvedic College and Hospital, Landmark-Buddha Murti, Kadamkuan, Patna-800003, Bihar
Patna
BIHAR |
8340135811
gunjal.priya26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee(IEC of Government Ayurvedic College and Hospital, Patna-800003, Bihar) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E611||Iron deficiency. 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: Ashtang Hrudya Uttarsthan (2/38-40), Route: Oral, Dosage Form: Churna/ Powder, Dose: 5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 2 Months, anupAna/sahapAna: Yes(details: -Madhu or Milk), Additional Information: -Total Patient - 30
-Duration - 2 Months (60 Days)
-Follow up - Every 15 Days and whenever required. |
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
-Patients of either sex from age 1 to 16 years.
-Children with haemoglobin level more than 6 gm/dl and less than 11gm/dl.
-Low Haemoglobin due to nutritional deficiency. |
|
| ExclusionCriteria |
| Details |
-Haemoglobin level less than 6gm/dl.
-Patient having occult blood positive on stool examination.
-Children having severe diseases like HIV, Tuberculosis, Juvenile diabetes and cardiac patient, any other type of anemia except IDA.
-IDA with any associated severe complication. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in the clinical signs and symptoms of Pandu Roga (Iron Deficiency Anemia) and increase in hemoglobin level after taking Rajanyadi Churna. |
Baseline and after 60 Days of treatment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in hemotological parameters (RBC, Hb%, Hematocrit) and overall physicall well being. |
Baseline and after 60 Days of treatment. |
|
|
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 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 present clinical study is designed to evaluate the efficacy and safety of Rajanyadi Churna in the management of Pandu Roga with special reference to Iron Deficiency Anemia in children. Pandu Roga described in Ayurveda closely resembles Iron Deficiency Anemia in modern medicine, characterized by pallor, fatigue, weakness, and poor appetite.In this study, children diagnosed with Pandu Roga will be selected based on specific inclusion and exclusion criteria. Rajanyadi Churna, a classical Ayurvedic formulation containing herbs with Deepana, Pachana, Raktavardhaka and Balya properties, will be administered in appropriate pediatric dosage for 60 days.The assessment will be carried out on both subjective parameters such as pallor, weakness, and appetite, and objective parameters including hemoglobin level, RBC count, serum iron, and hematocrit values. The outcomes will be compared before and after treatment to evaluate the effectiveness of Rajanyadi Churna in improving hematological status and overall health of children suffering from Pandu Roga. This study aims to provide scientific validation to the traditional Ayurvedic approach in managing Iron Deficiency Anemia and to establish Rajanyadi Churna as a safe and effective formulation for pediatric use. |