| 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
|
|
|
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
|
|
|
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 |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:D509||Iron deficiency anemia, unspecified. Ayurveda Condition: PANDUROGAH, |
|
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Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (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: - | | 2 | Intervention Arm | Drug | Classical | | (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: - |
|
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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. |
|
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Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
Centralized |
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Blinding/Masking
|
Participant Blinded |
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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. |