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CTRI Number  CTRI/2026/02/105003 [Registered on: 27/02/2026] Trial Registered Prospectively
Last Modified On: 16/02/2026
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   A study to evaluate the efficacy of Lohagudhadi Gutika by comparing with the efficacy of Punarnava mandura in iron deficiency anemia in children 
Scientific Title of Study   Randomized open - label clinical study on the efficacy of Lohagudhadi Gutika in Rasapradoshaja pandu with special reference to iron deficiency anemia in children with comparison to the efficacy of Punarnava mandura 
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 Rachana J  
Designation  PG scholar 
Affiliation  Sri Sri College of Ayurvedic Science and Research, Bangalore. 
Address  Room no-9, kaumarabhritya OPD, Sri Sri College of Ayurvedic science and Research Hospital, 21st K.M. Kanakapura Road, Udayapura. Bangalore KARNATAKA 560082 India

Bangalore Rural
KARNATAKA
560082
India 
Phone  7619353325  
Fax    
Email  rachanajayaram1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kripakaran P P  
Designation  Associate Professor  
Affiliation  Sri Sri College of Ayurvedic Science and Research, Bangalore. 
Address  Room no-9, kaumarabhritya OPD, Sri Sri College of Ayurvedic science and Research Hospital, 21st K.M. Kanakapura Road, Udayapura. Bangalore KARNATAKA 560082 India

Bangalore Rural
KARNATAKA
560082
India 
Phone  8921542722  
Fax    
Email  kripz850@gmail.com   
 
Details of Contact Person
Public Query  
Name  Dr Kripakaran P P  
Designation  Associate Professor  
Affiliation  Sri Sri College of Ayurvedic Science and Research, Bangalore. 
Address  Room no-9, kaumarabhritya OPD, Sri Sri College of Ayurvedic science and Research Hospital, 21st K.M. Kanakapura Road, Udayapura. Bangalore KARNATAKA 560082 India

Bangalore Rural
KARNATAKA
560082
India 
Phone  8921542722  
Fax    
Email  kripz850@gmail.com  
 
Source of Monetary or Material Support  
Sri Sri college of ayurveda science and research Bengaluru 560082. Karnataka. India. 
 
Primary Sponsor  
Name  Dr Rachana J  
Address  Sri Sri College of Ayurvedic science and Research, Bangalore 560082. Karnataka. India. 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rachana J   Sri Sri College of Ayurvedic and Research Hospital, Bangalore  Room no-9, kaumarabhritya OPD.
Bangalore Rural
KARNATAKA 		 7619353325

rachanajayaram1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRI SRI INSTITUTIONAL ETHICAL COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:D508||Other iron deficiency anemias. Ayurveda Condition: PANDUROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Punarnava mandura , Reference: Charaka samhita pandu roga chikitsa, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 200(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Buttermilk ), Additional Information: Punarnava mandura will be administered orally 1tabelt twice daily containing 200mg of mandura bhasma according to age appropriate doseage
2Intervention ArmDrugClassical(1) Medicine Name: Lohagudhadi Gutika , Reference: Sahasrayoga , Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 200(mg), Frequency: bd, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: Buttermilk ), Additional Information: Lohagudhadi Gutika will be administered orally 2tabelt twice daily containing 200mg of mandura bhasma according to age appropriate doseage
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1. Participants between the age group of 15years - 18years irrespective of their religion, gender and socio-economic status.
2. Participants presenting with the clinical features of mild to moderate anemia and haematocrit value less than 36% will be included. 3. Participants with clinical features of Rasapradoshaja Pandu roga.
4. Participants with cardinal signs of iron deficiency anemia.
5. Participants whose parents are willing to sign the written consent form and follow the protocol.  
 
ExclusionCriteria 
Details  1. Children with Hb% less than 7 g/dl (severe anemia).
2. Children with congenital anomalies, inborn errors of metabolism and with the evidence of any malignancy will be excluded.
3. Children with hepatic, renal dysfunction, chronic systemic illness and other hemoglobinopathies will be excluded.
4. History of hypersensitivity to any ingredient used in the medicinal preperation.  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Significant improvements in parameters of Pandu with special reference to iron deficiency anemia based on hematological parameters with the main focus on Hb%  0th - 30th - 45th day 
 
Secondary Outcome  
Outcome  TimePoints 
Generation of in-depth analysed data on different aspects of disease
Generation of data on possible unexpected drug reaction  		 6months - 1year 
 
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)   01/03/2026 
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="0"
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   Iron deficiency anemia remains highly prevalent among children due to increased nutritional demands during growth. 
Untreated IDA can cause impaired growth, cognitive deficits, and reduced academic performance. Although conventional iron supplements are effective, their gastrointestinal side effects often lead to poor compliance in children. Lohagudhadi Gutika, an Ayurvedic formulation containing Mandura Bhasma and Triphala, is traditionally indicated for anemia and is considered safe and well tolerated in children, but lacks scientific evaluation. Hence, this study aims to assess the efficacy, safety, and tolerability of Lohagudhadi Gutika in Rasapradoshaja Pandu (Iron Deficiency Anemia) in pediatric age group, in comparison with the standard control drug Punarnava Mandura.
 
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