| CTRI Number |
CTRI/2025/02/080783 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
21/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Darvyadi Leha in the Pandu roga (Iron Deficiency Anemia in Children) |
|
Scientific Title of Study
|
Clinical Study to Determine the Efficacy of Darvyadi Leha in the Management of Pandu roga w.s.r 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 |
Dr Naval Kishor Gurjar |
| Designation |
Md Scholar of Kaumarbhritya Department |
| Affiliation |
Madan Mohan Malviya Government Ayurved College Udaipur |
| Address |
PG Department of Kaumarbhritya, Madan Mohan Malviya Government Ayurved College,Rada ji circle Ambamata Udaipur 313001 Rajasthan.
Udaipur
RAJASTHAN
313001
India |
| Phone |
7727882146 |
| Fax |
|
| Email |
clnaval1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof. Ram Kumar |
| Designation |
Professor and Head of Kaumarbhritya Department |
| Affiliation |
Madan Mohan Malviya Government Ayurved College Udaipur |
| Address |
PG Department of Kaumarbhritya, Madan Mohan Malviya Government Ayurved College,Rada ji circle Ambamata Udaipur 313001 Rajasthan.
Udaipur
RAJASTHAN
313001
India |
| Phone |
8005857838 |
| Fax |
|
| Email |
drbhamuramkumar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naval Kishor Gurjar |
| Designation |
Md Scholar of Kaumarbhritya Department |
| Affiliation |
Madan Mohan Malviya Government Ayurved College Udaipur |
| Address |
PG Department of Kaumarbhritya, Madan Mohan Malviya Government Ayurved College,Rada ji circle Ambamata Udaipur 313001 Rajasthan.
Udaipur
RAJASTHAN
313001
India |
| Phone |
7727882146 |
| Fax |
|
| Email |
clnaval1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Madan Mohan Malviya Govt. Ayurved college Pharmacy.
Iron and Folic acid tablets from market. |
|
|
Primary Sponsor
|
| Name |
Madan Mohan Malviya Government Ayurved College Udaipur |
| Address |
Madan Mohan Malviya Government Ayurved College,Rada ji circle Ambamata Udaipur, Rajasthan, India.
Pin Code-313001 |
| Type of Sponsor |
Government medical college |
|
|
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 Naval Kishor Gurjar |
Campus hospital and Mottichohatta hospital |
Kaumarbhritya Opd no.4 in Campus hospital and Opd no.3 in mottichohatta hospital, Madan Mohan Malviya Government Ayurved College Udaipur (Rajasthan) 313001
Udaipur
RAJASTHAN |
7727882146
clnaval1997@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Madan Mohan Malviya Government Ayurved College Udaipur |
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: Darvyadi Leha, Reference: Bhaisajyaratnavali, Route: Oral, Dosage Form: Avleha/Leha/Paka/Raskriya, Dose: 15(mg), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: Madhu and Ghrit), Additional Information: Drug Dose will be 15mg/kg/day body weight for group A | | 2 | Comparator Arm (Non Ayurveda) | | - | Iron and folic acid | (1) Medicine Name: Iron and folic acid tablet, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 100(mg), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 8 Weeks, anupAna/sahapAna: Yes(details: Water), Additional Information: Drug Dose will be 1Tablet/day (100mg elemental Iron and 500 mcg folic acid) for group B |
|
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children whose parents are willing to give consent/assent for clinical trial.
1. Children aged between 6-12 years of either sex.
2. Children with Iron Deficiency Anemia(Hb between
7 gm% to 11.9 gm %). |
|
| ExclusionCriteria |
| Details |
Children suffering from major systemic illness necessitating long term treatment.
1. Children with evidence of malignancy.
2. Co-morbidity like TB, UTI and bleeding disorders etc.
3. H/o hypersensitivity to any of the trial drug or their ingredients.
4. Children who have completed participation in any other clinical trial during the past six
months.
5. Children with blood Hb less than 7gm/dl
6. Children Age below 6 years and above 12 years of either sex |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Effectiveness of darvyadi leha in Pandu roga |
8 Week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare bothe drugs Darvyadi leha & Iron & folic acid tablet |
8th Week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
20/07/2025 |
| 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="10"
Days="10" |
|
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
|
This Study is about CLINICAL STUDY TO DETERMINE THE EFFICACY OF DARVYADI LEHA IN THE MANAGEMENT OF PANDU ROGA W.S.R. TO IRON DEFICIENCY ANEMIA IN CHILDREN .There will be 2 Groups of a study, In Group A - Darvyadi Leha will be given = 15mg/kg/day with anupana Madgu and Ghrit = OD In Group B - Iron and folic acid tablets will be given = 1Tablet/day (100mg elemental Iron and 500 mcg folic acid) with anupana Water = OD Trial will be conduct for a period of 8 weeks and Follow up of the case will be after every 2nd week days that is 4 times ( At 2nd week ,At 4week ,At 6th week ,At 8th week ) during treatment. Final assessment will be done after completion of 8th week of treatment course on the basis of subjective, objective assessment and laboratory investigation. The results and observation will be analyzed and presented in accordance with the respective and applicable statistical test .
|