| CTRI Number |
CTRI/2026/01/100751 [Registered on: 09/01/2026] Trial Registered Prospectively |
| Last Modified On: |
02/01/2026 |
| 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 Vidangadya louha Vati on Iron Deficiency Anemia in Children |
|
Scientific Title of Study
|
Randomized Controlled Clinical Trial of Vidangadya louha Vati on Alparaktata of Panduroga (Iron Deficiency Anemia) in School Going 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 |
Dr Asmita Ashokrao Bhadre |
| Designation |
PhD Scholar in Kaumarbhritya |
| Affiliation |
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Paithan Road Chhatrapati Sambhajinagar |
| Address |
House No.3-2-1112, Survey No. - 8/1, Ashirwad Building, Samarth Colony, Degloor Road, Udgir, TAL. Udgir, Dist. Latur, Maharashtra 413517
1st Floor, Kaumarbhritya Department, CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Paithan Road Chhatrapati Sambhajinagar Maharashtra India 431011
Latur
MAHARASHTRA
413517
India |
| Phone |
8408917577 |
| Fax |
|
| Email |
asmita4192@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karuna Sunil Ratnparkhi |
| Designation |
Professor in Kaumarbhritya |
| Affiliation |
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Paithan Road Chhatrapati Sambhajinagar |
| Address |
1st Floor, Kaumarbhritya Department, CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Paithan Road Chhatrapati Sambhajinagar Maharashtra India 431011
Aurangabad
MAHARASHTRA
431011
India |
| Phone |
9421771722 |
| Fax |
|
| Email |
karunaratnaparkhi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Asmita Ashokrao Bhadre |
| Designation |
PhD Scholar in Kaumarbhritya |
| Affiliation |
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Paithan Road Chhatrapati Sambhajinagar |
| Address |
House No. 3-2-1112, Survey No. - 8/1, Ashirwad Building, Samarth Colony, Degloor Road, Udgir, TAL. Udgir, Dist. Latur, Maharashtra 413517
1st Floor, Kaumarbhritya Department, CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Paithan Road Chhatrapati Sambhajinagar Maharashtra India 431011
Latur
MAHARASHTRA
413517
India |
| Phone |
8408917577 |
| Fax |
|
| Email |
karunaratnaparkhi@gmail.com |
|
|
Source of Monetary or Material Support
|
| CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Paithan Road Chhatrapati Sambhajinagar Maharashtra India 431011 |
|
|
Primary Sponsor
|
| Name |
Dr Asmita Ashokrao Bhadre |
| Address |
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Paithan Road Chhatrapati Sambhajinagar Maharashtra India 431011 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| CSMSS Ayurved Mahavidyalaya and Rugnalaya |
CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Paithan Road Chhatrapati Sambhajinagar Maharashtra India 431011 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Asmita Ashokrao Bhadre |
CSMSS Ayurved Mahavidyalaya and Rugnalaya |
Kaumarbhritya OPD, CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Paithan Road Chhatrapati Sambhajinagar Maharashtra India 431011
Aurangabad
MAHARASHTRA |
8408917577
asmita4192@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-CSMSS Ayurved Mahavidyalaya and Rugnalaya Kanchanwadi Paithan Road Chhatrapati Sambhajinagar |
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: Vidangadya louha Vati, Reference: चक्रदत्त पाण्डुरोग अध्याय ८, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 4(), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: (2) Medicine Name: bd, Reference: Adhobhakta, Route: 60 Days, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: Koshnajal(-), Frequency: , Bhaishajya Kal: , Duration: , anupAna/sahapAna: No, Additional Information: | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: DHATRYAVLEHA, Reference: चरक चिकित्सास्थान अध्याय १६/१०१ , Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 4(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Ksheer), Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients showing cardinal signs of Pandu.
2. Children in between the age group of 6 years to 12 years .
3. Hemoglobin Percentage between 7 - 10 gm/dl.
4. Patients diagnosed as iron deficiency anemia by performing CBC.
5. Patients will be included irrespective of sex, religion, caste, socio-
economic status and food habits, etc. |
|
| ExclusionCriteria |
| Details |
1. Mridbhakshanjanya pandu .
2. Hb percentage below 6 gm/dl and above 11 gm/dl.
3. Patients suffering from major systemic disorders like severe
jaundice, congenital heart disease, bleeding disorders & all
seropositive patients.
4. Diagnosed cases of Hemolytic disorders.
5. Acute bleeding due to recent trauma will be excluded.
6. Other types of Anemia like Sickle cell, Thalassemia, Megaloblastic,
Aplastic Anemia etc.
7. Any patient requiring Hospitalization. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase in Hemoglobin (%) after 60 days of oral administration of Vidangadya louha Vati on Alparaktata of Panduroga (Iron Deficiency Anemia) in School Going Children |
after 60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in appetite
2. Decrease in pallor and fatigue
3. Weight Gain |
after 60 days |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
30/03/2026 |
| 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="0" |
|
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 present study is a Randomized Controlled Clinical Trial designed to evaluate the efficacy and safety of Vidangadya Louha Vati in the management of Alparaktata of Panduroga (Iron Deficiency Anemia) in school-going children. Iron deficiency anemia is one of the most common nutritional disorders seen in the paediatric age group, and it is associated with impaired performance in
mental and physical functions, including physical coordination and capacity,
cognitive abilities, and social and emotional development in children.
In this study, eligible children diagnosed with Alparaktata will be randomly allocated into two groups. The trial group will receive Vidangadya Louha Vati in an age-appropriate dose for 60 days, while the control group will receive Dhatravleha in age appropriate dose. Assessments will be made on both subjective parameters (clinical signs and symptoms of Panduroga such as panduta, Akshikuta Shotha, Aarohannayas, Shrama) and objective hematological parameters (Hemoglobin %, RBC count, RDW, MCV, MCH, MCHC, Sr. Iron, etc.).
The primary outcome will be the improvement in Hemoglobin percentage and clinical symptoms after 60 days of treatment, comparing pre- and post-treatment values.
The study aims to scientifically validate the classical Ayurvedic formulation Vidangadya Louha Vati as an effective and safe remedy for Iron Deficiency Anemia in school-going children, thereby contributing to evidence-based Ayurvedic pediatric practice (Kaumarbhritya).
|