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CTRI Number  CTRI/2026/02/105010 [Registered on: 27/02/2026] Trial Registered Prospectively
Last Modified On: 27/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   “Comparison of Two Ayurvedic Formulations Gud Haritaki & Darvyadi Leha in Managing Iron Deficiency Anaemia in Children” 
Scientific Title of Study   A Comparative Clinical Study to Evaluate The Efficacy Of Gud Haritaki and Dravyadi Leha In The Management Of Pandu Roga with special reference To Iron Deficiency Anaemia Amomg 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  Babita kumari 
Designation  PG scholar 
Affiliation  Government Ayurvedic college and hospital,patna,Bihar-800003, India. 
Address  Government Ayurvedic college,Near Buddha Murti, Kadamkuan,patna.

Patna
BIHAR
800003
India 
Phone  7707065355  
Fax    
Email  babitagupta7515@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Arvind Chaurasia 
Designation  Professor & HOD Department of Kaumarbhritya 
Affiliation  Government Ayurvedic college and hospital patna  
Address  Department of kaumarbhritya,2nd floor, Government Ayurved College,Near Buddha Murti Kadamkuan Patna Bihar - 800003, India

Patna
BIHAR
800003
India 
Phone  9835255180  
Fax    
Email  arvindschaurasia@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Arvind Chaurasia 
Designation  Professor & HOD Department of Kaumarbhritya 
Affiliation  Government Ayurvedic college and hospital patna  
Address  Department of kaumarbhritya,2nd floor, Government Ayurved College,Near Buddha Murti Kadamkuan Patna Bihar - 800003, India

Patna
BIHAR
800003
India 
Phone  9835255180  
Fax    
Email  arvindschaurasia@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Government Ayurvedic College and Hospital,patna 
Address  Government Ayurvedic College and Hospital Near Buddha Murti, Kadamkuan, Patna Bihar -800003, India. 
Type of Sponsor  Government medical college 
 
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 
DrArvind Chaurasia  Government Ayurvedic College and Hospital,Patna.  Department of kaumarbhritya,Government ayurvedic college and hospital,Buddha murti,Kadamkuan,Patna,Bihar-800003.
Patna
BIHAR 
7707065355

babitagupta7515@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Commitee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:D509||Iron deficiency anemia, unspecified. Ayurveda Condition: PANDUROGAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator ArmDrugClassical(1) Medicine Name: Gud Haritaki, Reference: Charak samhita , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: -Ushnodak), Additional Information: -
2Intervention ArmDrugClassical(1) Medicine Name: Darvyadi leha , Reference: Charak samhita and Bhaishajya ratnavali , Route: Oral, Dosage Form: Churna/ Powder, Dose: 3(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 1 Months, anupAna/sahapAna: Yes(details: -madhu and ghrit ), Additional Information: -
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  1.Children with haemoglobin level in between 7-10 g/dl.
2.The patients will be selected on the basis of Hb% found in laboratory.
3.Patients with classical symptoms of pandu roga. 
 
ExclusionCriteria 
Details  1.Blood Hb% less than 7 g/dl.
2.patients with hereditary anaemia (eg-Thalassemia, aplastic anaemia,sickle cell anaemia etc.)and any other types of anaemia except iron deficiency anaemia.
3.Iron deficiency anaemia with any associated severe complications. 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Centralized 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Improvement in the Daurbalyata Shrama,Aruchi,Shwasa Hridayaspandana sign and symptoms of pandu roga.  1 month.

 
 
Secondary Outcome  
Outcome  TimePoints 
Changes in the laboratory investigation.To assess the efficacy of trial drug.  1 month. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   15/03/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  15/03/2026 
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 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  
Pandu is a disease characterized by pallor of body which strikingly resembles with "Anaemia’ of modern science. Iron deficiency anaemia (IDA) is a very common nutritional disorder worldwide and is known to affect approximately one third of the global population. While its incidence in affluent countries is low, the incidence of IDA in India is very high. According to National Family Health Survey (NFHS) III data, the incidence of anemia in urban children is 71%, rural is 84%, and overall is 79%. It occurs when there is a decrease in total iron body content, severe enough to diminish erythropoiesis and cause anaemia. Rakta has been considered as a key factor for the Jeevana, Prinana, Dharana and Poshana karma of the body. Many a times it is seen that Rakta gets vitiated by Doshas, mainly by Pitta dosha as Rakta is Pittavargiya and disease like Pandu appear. In Ayurveda, Pandu is considered as a specific disease with its own pathogenesis and treatment. Thus an attempt has been made to study disease Pandu Roga according to Ayurvedic text in the parlance of Iron Deficiency Anaemia. In modern medicine, there is good treatment for Anaemia with considerable result but that is only for acute deficiencies Anaemia. No significant therapy is there for Chronic Anaemia which occur due to metabolic defects. Ayurveda can provide better management in this area. Iron deficiency anaemia is the most common type of anaemia throughout the world, although it occurs to a lesser extent in the United States because of the higher consumption of iron-rich red meat and the practice of food fortification (addition of iron to foods by manufacturers). In developing countries in tropical climates, the most common cause of iron deficiency anemia is infestation with worm.
Guda Haritaki yoga is one of the important medicines used in Panduroga mentioned in Bhaisajya Ratnavali. The primary etiological factor for Panduroga is Mandagni. With the aid of Haritaki’s deepana and pachana qualities, it can be cured. Pandu roga mostly contains vitiated rasa and rakta dhatu. Haritaki, a Rasayana medication, aids in restoring balance to vitiated Dhatu and encouraging the manufacture of healthy Dhatu. According to modern science Haritaki has antibacterial, anthelminthics, antioxidant, and immunomodulatory effects. Minerals like Iron and calcium are prevalent in jaggery (Gud), a sugarcane product. Jaggery contains 10-13 mg of iron per 100 g. Darvyadi Leha is a classical Ayurveda herbomineral formulation for Pandu Roga (anemia) described in Charak Samhita. Most of the ingredients of Darvyadi Leha possess qualities like Tridoshahara, Deepana, Pachana, Hridya, Yakriduttejaka, Krimighna, Shwasahara, Raktavardhaka and Rasayana. Both the drugs will help in managing pandu roga very well that’s why the present study entitled "A comparative clinical study to evaluate the efficacy of Gud haritaki & Darvyadi leha in the management of pandu roga W.S.R Iron deficiency anemia among children.
 
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